2019 IL and Federal Pharmacy Law Review PDF

2019 Illinois and Federal Pharmacy Law Review
PharmacyLaw.net
1547 Warren Avenue
Downers Grove, IL 60515
ILExam@pharmacylaw.net
www.pharmacylaw.net
Section 1 Pharmacy Law Review – Main Handout
Section 2 Practice Exam Questions
Section 3 Federal Poison Prevention Packaging Act
Section 4 Federal Health Insurance Portability and Accountability Act

(“HIPAA”)
© 2019 Edward D. Rickert (All Rights Reserved)

DO NOT COPY OR DISTRIBUTE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION
SECTION 1
PHARMACY LAW REVIEW
Main Handout

SECTION ONE
GENERAL EXAM INFORMATION
MPJE® Registration Bulletin has information about the exam. Much of the following information comes from
that bulletin. (https://nabp.pharmacy/wp-content/uploads/2019/02/NAPLEX-MPJE-Bulletin-
Feb-2019.pdf)
Time allotment - 2.5 hours
• You will be given 3 hours from the time you sit at the computer to allow for time to read and agree to
the confidentially/non-disclosure agreement, tutorial, and post-exam survey.
o Getting comfortable with the format: There is a computerized tutorial that will let you get
used to the computer and exam question format at the beginning. This DOES NOT count in
your allotted time - take your time to use this to get comfortable with the equipment and
exam question format.
o No breaks – use the bathroom before you start the test.
• Materials available at Exam Location: The administrator will provide you with an erasable note
board and pen. You may not remove these materials from the testing room at any time. Using your
own scratch paper or pen is prohibited.
• No reference, study, or other materials or devices may be brought into the testing center.
• Calculator – No longer provided on computer for MPJE®. Cannot bring your own. The NABP bulletin
states that a calculator is not required for the MPJE®, and if a candidate requests a calculator, it will
NOT be provided. If there are calculations on MPJE® you will need to perform them the old-fashioned
way.
• The number of questions was increased from 90 to 120 questions in 2016.

o 100 will be used to produce a score and 20 will be non-scored pretest items. Pretest
questions are scattered throughout the exam and are not identified.
o Penalty applied if you do not complete the exam:
 To receive an MPJE® test score, you must have completed at least 107 questions on
the examination. Candidates completing fewer than 107 questions will not have their
scores reported.
 Candidates who complete at least 107 questions, but fewer than 120 questions, will
have a penalty applied and their scores adjusted to reflect the number of questions
that remained unanswered. Therefore, it is in the candidate’s best interest to answer
all questions presented.
• Scaling: Some questions may be "weighted" more heavily, but you will not be able to identify these.
• You need to score "75" to pass. This is a “scaled” score and does not mean 75% - you may pass with
less than 75%, and may not with more than 75%. Depends on how questions are weighted.
“Pharmacy Practice” questions are likely given greater weight.
• Adaptive Format - “Adaptive" = computer selects questions for each candidate based on candidate's
ability level (your prior answers). If you answer a question correctly, the computer selects a more
difficult question; if you answer incorrectly, an easier question is selected. The number of questions
answered correctly and the difficulty level are factored into the scoring
• DO NOT try to attempt to figure out if the questions are getting easier/harder. This will not help you;
it will only distract you. Remember, the exam is based on your ability level - you will likely not be
able to detect a difference!
1
© 2019, Edward D. Rickert (All Rights Reserved)
• Answering questions: You'll be able to practice this in the tutorial before the real exam starts. Select;
submit; confirm. Once you confirm an answer, you cannot change it! You will not be able to go back
and change answers to your questions as you take the exam.
AREAS COVERED ON EXAM
Area 1 – Pharmacy Practice (83%)

 1.1 Legal responsibilities of the pharmacist and other pharmacy personnel
 1.1.1 Unique legal responsibilities of the pharmacist-in-charge (or equivalent), pharmacists, interns,
and pharmacy owners
 Responsibilities for inventory, loss and/or theft of prescription drugs, the
destruction/disposal of prescription drugs and the precedence of Local, State, or Federal
requirements
 1.1.2 Qualifications, scope of duties, and conditions for practice relating to pharmacy technicians and
all other non-pharmacist personnel
 Personnel ratios, duties, tasks, roles, and functions of non-pharmacist personnel
 1.2 Requirements for the acquisition and distribution of pharmaceutical products, including
samples
 1.2.1 Requirements and record keeping in relation to the ordering, acquiring, and maintenance of all
pharmaceutical products and bulk drug substances/excipients
 Legitimate suppliers, pedigrees and the maintenance of acquisition records
 1.2.2 Requirements for distributing pharmaceutical products and preparations, including the content
and maintenance of distribution records
 Legal possession of pharmaceutical products (including drug samples), labeling, packaging,
repackaging, compounding, and sales to practitioners
 1.3 Legal requirements that must be observed in the issuance of a prescription/drug order
 1.3.1 Prescription/order requirements for pharmaceutical products and the limitations on their
respective therapeutic uses
 Products, preparations, their uses and limitations applicable to all prescribed orders for both
human and veterinary uses
 1.3.2 Scope of authority, scope of practice, and valid registration of all practitioners who are
authorized under law to prescribe, dispense, or administer pharmaceutical products, including
controlled substances
 Federal and State registrations, methadone programs, office-based opioid treatment
programs, regulations related to retired or deceased prescribers, Internet prescribing, limits
on jurisdictional prescribing
 1.3.3 Conditions under which the pharmacist participates in the administration of pharmaceutical
products, or in the management of patients' drug therapy
 Prescriptive authority, collaborative practice, consulting, counseling, medication
administration (including immunization, vaccines), ordering labs, medication therapy
management, and disease state management
 1.3.4 Requirements for issuing a prescription/order
 Content and format for written, telephonic voice transmission, electronic facsimile,
computer and Internet, during emergency conditions, and tamper-resistant prescription
forms.
 1.3.5 Requirements for the issuance of controlled substance prescriptions/orders
 Content and format for written, telephonic voice transmission, electronic facsimile,
computerized and Internet, during emergency conditions, conditions for changing a
prescription, time limits for dispensing initial prescriptions/drug orders, and requirements
for multiple Schedule II orders
 1.3.6 Limits of a practitioner’s authority to authorize refills of a pharmaceutical product, including
controlled substances
2
 1.4 Procedures necessary to properly dispense a pharmaceutical product, including
controlled substances, pursuant to a prescription/drug order
 1.4.1 Responsibilities for determining whether prescriptions/orders were issued for a legitimate
medical purpose and within all applicable legal restrictions
 Corresponding responsibility, maximum quantities, restricted distribution systems, red
flags/automated alerts, controlled substances, valid patient / prescriber relationship, and
due diligence to ensure validity of the order
 1.4.2 Requirements for the transfer of existing prescription/order information from one pharmacist
to another
 1.4.3 Conditions under which a prescription/order may be filled or refilled
 Emergency fills or refills, partial dispensing of a controlled substance, disaster or emergency
protocol, patient identification, requirement for death with dignity, medical marijuana, and
conscience /moral circumstances
 1.4.4 Conditions under which prospective drug use review is conducted prior to dispensing
 Patient specific therapy and requirements for patient specific documentation
 1.4.5 Conditions under which product selection is permitted or mandated
 Consent of the patient and/or prescriber, passing-on of cost savings, and appropriate
documentation
 1.4.6 Requirements for the labeling of pharmaceutical products and preparations dispensed
pursuant to a prescription/order
 Generic and therapeutic equivalency, formulary use, auxiliary labels, patient package inserts,
FDA medication guides, and written drug information
 1.4.7 Packaging requirements of pharmaceutical products, preparations, and devices to be dispensed
pursuant to a prescription/order
 Child-resistant and customized patient medication packaging
 1.4.8 Conditions under which a pharmaceutical product, preparation, or device may not be
dispensed
 Adulteration, misbranding, and dating
 1.4.9 Requirements for compounding pharmaceutical products
 Environmental controls, release checks and testing, beyond use date (BUD), initial and
ongoing training
 1.4.10 Requirements for emergency kits
 Supplying, maintenance, access, security, and inventory
 1.4.11 Conditions regarding the return and/or reuse of pharmaceutical products, preparations, bulk
drug substances/excipients, and devices
 Charitable programs, cancer or other repository programs, previously dispensed, and from
""will call"" areas of pharmacies
 1.4.12 Procedures and requirements for systems or processes whereby a non-pharmacist may
obtain pharmaceutical products, preparations, bulk drug substances/excipients, and devices
 Pyxis (vending), after hour’s access, telepharmacies, and secure automated patient drug
retrieval centers
 1.4.13 Procedures and requirements for establishing and operating central processing and central
fill pharmacies
 Remote order verification
 1.4.14 Requirements for reporting to PMP, accessing information in a PMP and the maintenance of
security and confidentiality of information accessed in PMPs
 1.4.15 Requirements when informed consent must be obtained from the patient and/or a duty to
warn must be executed
 Collaborative practice and investigational drug therapy
 1.5 Conditions for making an offer to counsel or counseling appropriate patients, including
the requirements for documentation
 1.5.1 Requirements to counsel or to make an offer to counsel
 1.5.2 Required documentation necessary for counseling
 1.6 Requirements for the distribution and/or dispensing of non-prescription pharmaceutical
products, including controlled substances
3
 1.6.1 Requirements for the labeling of non-prescription pharmaceutical products and devices
 1.6.2 Requirements for the packaging and repackaging of non-prescription pharmaceutical products
and devices
 1.6.3 Requirements for the distribution and/or dispensing of poisons, restricted, non-prescription
pharmaceutical products, and other restricted materials or devices
 Pseudoephedrine, dextromethorphan, emergency contraception, and behind the counter
products as appropriate
 1.7 Procedures for keeping records of information related to pharmacy practice,
pharmaceutical products and patients, including requirements for protecting patient
confidentiality
 1.7.1 Requirements pertaining to controlled substance inventories
 1.7.2 Content, maintenance, storage, and reporting requirements for records required in the
operation of a pharmacy
 Prescription filing systems, computer systems and backups, and prescription monitoring
programs
 1.7.3 Requirements for protecting patient confidentiality and confidential health records
 HIPAA requirements and conditions for access and use of information
 1.8 Requirements for handling hazardous materials such as described in USP <800>
 1.8.1 Requirements for appropriate disposal of hazardous materials
 1.8.2 Requirements for training regarding hazardous materials
 Reverse distributors, quarantine procedures, comprehensive safety programs, Material
Safety Data Sheets
 1.8.3 Environmental controls addressing the proper storage, handling, and disposal of hazardous
materials
 Ventilation controls, personal protective equipment, work practices, and reporting
 1.8.4 Methods for the compounding, dispensing and administration of hazardous materials
 All hazardous materials including sterile and non-sterile compounding
Area 2 – Licensure, Registration, Certification, and Operational Requirements (15%)

 2.1 Qualifications, application procedure, necessary examinations, and internship for
licensure, registration, or certification of individuals engaged in the storage, distribution,
and/or dispensing of pharmaceutical products (prescription and non-prescription)
 2.1.1 Requirements for special or restricted licenses, registration, authorization, or certificates
 Pharmacists, pharmacist preceptors, pharmacy interns, pharmacy technicians, controlled
substance registrants, and under specialty pharmacist licenses (Nuclear, Consultant etc.)
 2.1.2 Standards of practice related to the practice of pharmacy
 Quality assurance programs (including peer review), changing dosage forms, therapeutic
substitution, error reporting, public health reporting requirements (such as notification of
potential terrorist event, physical abuse, and treatment for tuberculosis), and issues of
conscience and maintaining competency
 2.1.3 Requirements for classifications and processes of disciplinary actions that may be taken against
a registered, licensed, certified, or permitted individual
 2.1.4 Requirements for reporting to, and participating in, programs addressing the inability of an
individual licensed, registered, or certified by the Board to engage in the practice of pharmacy with
reasonable skill and safety
 Impairment caused by the use of alcohol, drugs, chemicals, or other materials, or mental,
physical, or psychological conditions
 2.2 Requirements and application procedure for the registration, licensure, certification, or
permitting of a practice setting or business entity
 2.2.1 Requirements for registration, license, certification, or permitting of a practice setting
 In-state pharmacies, out-of-state pharmacies, specialty pharmacies, controlled substance
registrants, wholesalers, distributors, manufacturers/repackagers, computer services
providers, and internet pharmacies
 2.2.2 Requirements for an inspection of a licensed, registered, certified, or permitted practice setting
4
 2.2.3 Requirements for the renewal or reinstatement of a license, registration, certificate, or permit
of a practice setting
 2.2.4 Classifications and processes of disciplinary actions that may be taken against a registered,
licensed, certified, or permitted practice setting
 2.3 Operational requirements for a registered, licensed, certified, or permitted practice
setting
 2.3.1 Requirements for the operation of a pharmacy or practice setting that is not directly related to
the dispensing of pharmaceutical products
 Issues related to space, equipment, advertising and signage, security (including temporary
absences of the pharmacist), policies and procedures, libraries and references (including
veterinary), and the display of licenses
 2.3.2 Requirements for the possession, storage, and handling of pharmaceutical products,
preparations, bulk drug substances/excipients, and devices, including controlled substances
 Investigational new drugs, repackaged or resold drugs, sample pharmaceuticals, recalls, and
outdated pharmaceutical products
 2.3.3 Requirements for delivery of pharmaceutical products, preparations, bulk drug
substances/excipients, and devices, including controlled substances
 Issues related to identification of the person accepting delivery of a drug, use of the mail,
contract delivery, use of couriers, use of pharmacy employees, use of kiosks, secure mail
boxes, script centers, use of vacuum tubes, and use of drive-up windows
Area 3 – General Regulatory Processes (2%)

 3.1 Application of regulations
 3.1.1 Laws and rules that regulate or affect the manufacture, storage, distribution, and dispensing of
pharmaceutical products, preparations, bulk drug substances/excipients, and devices, (prescription
and non-prescription), including controlled substances
• Food, Drug, and Cosmetic Act(s) and Regulations, the Controlled Substances Act(s) and Regulations,
OBRA 90's Title IV Requirements, Practice Acts and Rules, other statutes and regulations, including
but not limited to, dispensing of methadone, child-resistant packaging, tamper resistant packaging,
drug paraphernalia, drug samples, pharmacist responsibilities in Medicare-certified skilled-nursing
facilities, NDC numbers, and schedules of controlled substances
Exam Format (Directly from MPJE® Bulletin)

• Basic multiple choice:
How many total continuing pharmacy education hours are required to be completed upon the second
renewal of a pharmacist’s license in this jurisdiction?
A. 15
B. 20
C. 25
D. 30
E. 40
• Multiple Response:
Which of the following medications are classified as Schedule II controlled substances in this
jurisdiction? (Select ALL that apply.)
A. Strattera
B. Lisdexamfetamine
C. Meprobamate
5
D. Pemoline
E. Dexmethylphenidate
• Ordered Response Question Format:
Place the following in the order in which they would expire according to federal regulations, starting
with the earliest. (ALL options must be used.) 1
Left-click the mouse to highlight, drag, and order the answer options.
Unordered Options Ordered Response

1. A partially filled methylphenidate prescription
for a patient not in a long-term care facility
2. A phoned-in, emergency oxycodone prescription
3. A written bupropion prescription
4. An electronic pemoline prescription
5. A partially filled morphine prescription for a
patient in a long-term care facility
GENERAL TIPS FOR SUCCESS

The exam has many "pharmacy practice" questions that are geared more towards retail pharmacy.
“Pharmacy practice” questions may be weighed more heavily. Review the following:
o For drugs that are available both OTC and RX-only, you should know what strengths are OTC
and which are RX-only.
o You must be familiar with the names (brand and generic) and schedules of controlled
substances. For non-controlled substances, know brand and generic names of commonly
prescribed drugs.
o Expect some off-the-wall questions that you cannot answer. Answer to the best of your
ability and move on! Use common sense!
Examples of “goofy” questions:
o How are poisons and alcohol regulated?
o How long after a doctor dies can you continue to refill an otherwise refillable prescription?
o If there is a fire in the front end of your pharmacy, but the flames do not reach the
prescription department, are the drugs there (a) misbranded, (b) adulterated, (c) both, (d)
neither?
o Who is best suited to deliver a prescription to a patient in their home? (a) pharmacist, (b)
technician, (c) cab driver, (d) non-pharmacist/non-technician clerk employed by the
pharmacy.
You must pick the BEST answer, even when there is more than one "good" choice, and even when none of the
choices make sense.
Do NOT overanalyze questions. They really are NOT trying to trick you.
Take the exam seriously. Begin studying early. Use the Competency Statements as your guide to which areas
to focus most of your efforts. (Hint: 84% is more than 2%.)
There is no penalty for guessing, but make educated guesses.
Begin studying early – do not wait until the last minute.
1 Answer: 1 (72 hours under state law/30 days under federal law), 2 (7 days), 5 (60 days), 4 (180 days), 3 (365 days).
6
ILLINOIS AND FEDERAL CONTROLLED SUBSTANCES ACTS
The state and federal controlled substances acts regulate the manufacture, distribution, dispensing and
delivery of controlled substances. The Drug Enforcement Administration (“DEA”) is the federal agency
responsible for enforcing controlled substances laws. The Department of Human Services, Office of
Alcoholism and Substance Abuse and the Department of Financial and Professional Regulation are the Illinois
agencies responsible for monitoring and enforcement of the Illinois act.
Suggested Reading: Pharmacist’s Manual
• Access at http://www.deadiversion.usdoj.gov/; click on “Publications and Manuals”; then
“Manuals” – see “Pharmacist’s Manual in html and pdf formats)
• Also a good idea to review general “Q&A” page on DEA website.
• There is also a list of all federal scheduled controlled substances, information about forms,
applications, and other useful information available on the site.
Controlled substances are regulated by both Federal and State Laws
• If state law and federal law overlap, state law must be more stringent to be valid. (e.g. Illinois
Controlled Substance Act)
• One notable “exception” is “Medical Marijuana ("MMJ")”; if there are questions on MMJ on
the exam; Marijuana is still considered a schedule I controlled substance under federal law.
• Note: questions on the MPJE® should be answered with the “most stringent” law in mind. Where
Illinois and federal law differ, answer the question with regard to the stricter law.
o Example: Federal law permits persons 18 years old or older to purchase certain liquid
cough and cold preparations containing codeine (referred to as “exempt narcotics”) without
a prescription. In Illinois, the purchaser must be at least 21 years old. Illinois law is more
stringent. If the exam asks “In your jurisdiction, how old must a patient be to purchase
exempt narcotics without a prescription”, and the choices are “a. 21 years old, b. 18 years old,
c. 25 years old d. 16 years old, e. none of the above”, the correct answer is “a.”
Drug Enforcement Administration (DEA) is part of the Department of Justice (DOJ)
1970 – Controlled Substances Act (CSA)
• Also known as Title 2 of the Comprehensive Drug Abuse Prevention and Control Act of 1970
• Gave FDA authority to determine the scheduling of controlled substances
• Repealed earlier laws and created a comprehensive approach to preventing drug abuse
1973 – Creation of the DEA by Department of Justice.
• Removed Scheduling responsibility from the FDA
• Provided the DEA with the following functions associated with CSA: Interpretation: Implementation;
Enforcement; Development of regulations
Controlled Substances – Closed System of Distribution; this is a key concept for understanding the CSA
and regulations!
• The federal controlled substances laws and regulations are intended to create a "closed system of
distribution, such that only the substances themselves are scheduled, and all persons with lawful
access are registered. Access to controlled substances are restricted through REGISTRATION and
SCHEDULING.
• Once a scheduled substance leaves the closed system of distribution, and can only re-enter the closed
system under limited circumstances.
Registration and Scheduling – Cornerstones of the “Closed System of Distribution”.
7
• Scheduling: Substances that have the potential for abuse, or can cause addiction, are scheduled into
one of 5 schedules. Note that the laws of some states add additional schedules. Illinois law follows
federal law, and has 5 schedules that correspond to the federal schedules.
• Registration: All who come in contact with controlled substances must be registered (or in some
cases employed by a registered entity) with the exception of the patient that has a legitimate medical
need for the medication, and accesses it through a valid prescription.
• Once a scheduled substance leaves the “closed system”, it cannot re-enter.

o Example:
- A manufacturer makes Vicodin, which it sells to a distributor. The distributor sells the
product to the pharmacy. The pharmacy receives a prescription from a doctor. The
manufacturer, distributor, pharmacy and prescriber are all registered with the DEA.
- The Vicodin prescription is filled by the pharmacy and dispensed to the patient. The
patient is NOT registered with the DEA. The patient can access the medication only because
s/he has a valid prescription.
- If a patient no longer wants the Vicodin, s/he can return it to the pharmacy only under very
limited circumstances.
Returning Controlled Substances to a Pharmacy
Question: What happens if the patient no longer needs the medication – can it be returned to the
pharmacy??
Answer: No!!! When it is dispensed to the patient, it leaves the closed distribution network. It cannot
re-enter that closed network.
Exception: DEA regulations permit a CS can be returned to the pharmacy when:
(1) There has been dispensing error, and the improperly dispensed CS is brought back to the
pharmacy;
(2) There has been a recall of the drug; or
(3) The pharmacy to register as an authorized collector of controlled substances by amending its
existing registration to add this additional category.
See, http://www.deadiversion.usdoj.gov/faq/prescriptions.htm (accessed 2/14/2019). Note that in these
situations, the pharmacy can take the drug back, but obviously cannot re-dispense it.
Exam Tip: Only Manufacturers, distributors, reverse distributors, narcotic treatment programs,
hospitals/clinics with an on-site pharmacy, and retail pharmacies are permitted to be an authorized
collector. Physicians and other practitioners, hospitals without a pharmacy, and clinics without a
pharmacy cannot be an authorized collector of controlled substances.
To qualify for registration as an authorized collector, the registrant must be registered to handle schedule II
controlled substances.
There are two permissible methods for an authorized collector to take back controlled substances: (1)
maintaining collection receptacles and (2) administering mail-back programs. In addition, the regulations
allow authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at
long-term care facilities.
The new regulations do not require a particular method of destruction, so long as the desired result is
achieved. Pharmaceutical controlled substances must be rendered “non-retrievable” in compliance with all
applicable Federal, State, tribal and local laws. This standard is intended to allow public and private entities
to develop a variety of destruction methods that are secure, convenient, and responsible, consistent with
preventing the diversion of such substances.
8
“Non-retrievable” means the condition or state to which a controlled substance shall be rendered following a
process that permanently alters that controlled substance’s physical or chemical condition or state through
irreversible means and thereby renders the controlled substance unavailable and unusable for all practical
purposes. A controlled substance is considered “non-retrievable” when it cannot be transformed to a physical
or chemical condition or state as a controlled substance or controlled substance analogue.
Collection by Law Enforcement Agencies – In addition to Authorized Collectors, law enforcement agencies
are permitted to take back controlled substances. No DEA registration is required for the law enforcement
agency.
DEA Take Back programs: From time to time throughout the year, DEA sponsors “National Prescription
Take Back Days”. It partners with local law enforcement to encourage patients to bring unused controlled
substances to law enforcement for proper disposal.
Exam Tip: Patients are not required to bring controlled substances to an authorized collector or to law
enforcement for destruction. They are permitted to destroy substances themselves.
Registration
Every person or firm that manufactures, distributes, dispenses (including prescribing and administering),
conducts instructional activities with, exports, imports or conducts narcotic maintenance or detoxification
programs with controlled drugs must register with federal DEA unless exempted under law or regulations.
Classifications - eleven (11) categories, grouped by activity:
• (1) manufacturer; (2) distributor; (3) dispenser (C-II thru C-V); (4) research; other than narcotic
treatment program (C-II thru C-V); (5) instructional activities (C-II thru C-V); (6) narcotic treatment
programs (C-II thru C-V); (7) research with C-I substances; (8) chemical analysis; (9) importer; (10)
exporter (C-I thru C-IV); and (11) compounding by mixing, preparing, packaging or changing dosage
form of C-II thru C-V narcotic for use in maintenance or detoxification by another narcotic treatment
program. (“detox compounder”)
For MPJE® purposes, the most important categories are: (1) manufacturer; (2) distributor; (3) dispenser (C-II
thru C-V); (4) narcotic treatment program; and (5) detox compounder. That is because these are the types of
registrations a pharmacy may be required to obtain, depending on its activities.
Exam Tip: Note that a “dispenser” registration is the type of registration that is issued to a doctor or
mid-level practitioner who “prescribes” a controlled substance. There is no such thing as a “prescriber”
registration.
Note – The Illinois and DEA registration can be limited by schedule. In other words, a practitioner can have a
DEA registration for just CIII, IV and V substances. It can also be limited by drug class (narcotic versus non-
narcotic).
An application for controlled substance registration is divided into the following categories:
• II narcotic
• II non-narcotic
• III narcotic
• III non-narcotic
• IV
• V
Exam Tip: A dispenser may voluntarily limit his/her registration, by selecting only certain schedules
when completing the DEA registration application or renewal. In addition, the DEA may limit a
dispenser's registration. This occurs when the DEA believes that continued registration in all categories is
inconsistent with the public interest.
Exam Tip: In practice, pharmacists, physicians and other health care professionals sometimes refer to all
CIIs as "narcotics". That is not correct. Narcotics are a limited subgroup of controlled substances.
9
Under federal law, a "narcotic" means any of the following whether produced directly or indirectly by
extraction from substances of vegetable origin or independently by means of chemical synthesis or by a
combination of extraction and chemical synthesis:
(1) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and
salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers and salts is
possible within the specific chemical designation. Such term does not include the isoquinoline
alkaloids of opium.
(2) Poppy straw and concentrate of poppy straw.
(3) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine and
derivatives of ecgonine or their salts have been removed.
(4) Cocaine, its salts, optical and geometric isomers, and salts of isomers.
(5) Ecgonine, its derivatives, their salts, isomers and salts of isomers.
(6) Any compound, mixture, or preparation which contains any quantity of any of the substances
referred to in paragraphs (1) through (5) of this definition.
Illinois defines a "narcotic" exactly the same way as the federal law.
Applying for a DEA Registration

Applicant for a Controlled Substance Registration: The applicant must be an owner, active partner, or any
corporate officer. May assign, by power of attorney, another person to sign orders for purchases of controlled
drugs.
When an entity applies for the registration, the registration form is signed by the “owner”. The “owner” is:
• The “sole proprietor” if the entity is a sole proprietorship (i.e., “Joe’s Pharmacy” – Joe completes the
form).
• Partnership – Any partner is the owner, and can complete the form (i.e., “Joe and Flo’s Pharmacy” –
either Joe or Flo can complete the form.)
• Corporation – Any Officer or Director of the corporation can complete the form.
• The person who completes the form is referred to as the “registrant”. The entity that receives the
registration is also called the “registrant”.
Power of Attorney ("POA") – Method for delegating responsibility to another person at the store level.
21 CFR §1305.05 Power of attorney.
(a) A registrant may authorize one or more individuals, whether or not located at his or her
registered location, to issue orders for Schedule I and II controlled substances on the registrant's
behalf by executing a power of attorney for each such individual. The POA is maintained on-site at
the registered location with executed Forms 222 where applicable, for the same period as any order
bearing the signature of the attorney. The power of attorney must be available for inspection
together with other order records.
(b) A registrant may revoke any power of attorney at any time by executing a notice of revocation.
(c) The power of attorney and notice of revocation must be similar to the following format:
Power of Attorney for DEA Forms 222 and Electronic Orders
(Name of registrant)
(Address of registrant)
(DEA registration number)
10
I, ____ (name of person granting power), the undersigned, who am authorized to sign the current application for registration of
the above-named registrant under the Controlled Substances Act or Controlled Substances Import and Export Act, have made,
constituted, and appointed, and by these presents, do make, constitute, and appoint ____ (name of attorney-in-fact), my true
and lawful attorney for me in my name, place, and stead, to execute applications for Forms 222 and to sign orders for Schedule
I and II controlled substances, whether these orders be on Form 222 or electronic, in accordance with 21 U.S.C. 828 and Part
1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and confirm all that said attorney must lawfully do or cause
to be done by virtue hereof.
(Signature of person granting power)
I, ____ (name of attorney-in-fact), hereby affirm that I am the person named herein as attorney-in-fact and that the signature
affixed hereto is my signature.
(signature of attorney-in-fact)
Witnesses:
1. ______
2. ______
Signed and dated on the ____ day of ____, (year), at ____ .
Notice of Revocation
The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign the current application for
registration of the above-named registrant under the Controlled Substances Act or the Controlled Substances Import and
Export Act. Written notice of this revocation has been given to the attorney-in-fact ____ this same day.
(Signature of person revoking power)
Witnesses:
1. ______
2. ______
Signed and dated on the ____ day of ____, (year), at ____.
(d) A power of attorney must be executed by the person who signed the most recent application for
DEA registration or reregistration; the person to whom the power of attorney is being granted; and
two witnesses.
(e) A power of attorney must be revoked by the person who signed the most recent application for
DEA registration or reregistration, and two witnesses.
Exam Tip: The POA is an important concept. The POA is used to provide authority to execute federal
order forms to obtain schedule II controlled substances. The POA can be assigned to anyone - not just
pharmacists, including non-pharmacist owners, technicians, pharmacy interns (students), and even
unlicensed persons. However, read exam questions carefully, because it is always preferable (even if not
legally required) that only pharmacists order controlled substances.
Pharmacy Registration: Pharmacies register as a dispenser of controlled substances. One registration
covers dispensing of all C-II thru C-V substances. Employee pharmacist need not obtain separate registration.
Exam Tip: If RPh has prescribing authority, s/he will need to have his/her own individual DEA number
(because s/he is not dispensing under the pharmacy registration, but is making an independent
prescribing decision). Pharmacists do not have prescribing authority in Illinois, but in other states, a
pharmacist with controlled substance prescriptive authority would register as a mid-level practitioner.
• Pharmacies and other dispensers register with DEA Form 224 for initial registration, and DEA 224a
for renewal. Renewal is every 3 years.
• Separate registration needed for each pharmacy owned or operated by same entity.
Exam Tip: Neither federal nor Illinois law require the applicant or the person with POA to be pharmacist.
However, under state law, the ordering, securing and dispensing of controlled substances is
responsibility of PIC, regardless of whether the PIC is the registrant, and regardless of whether the PIC
has POA.
11
Hospital registrations: Hospitals register “institutional practitioners”. This registration is issued to the
entire hospital, allowing controlled substances to be stored anywhere in the registered location, and to give
employee practitioners, nurses, pharmacists the authority to possess, prescribe, dispense, and administer
controlled substances.
• A separate registration for pharmacy is not required; pharmacy is permitted to use the institutional
dispenser registration issued to hospital.
• An institutional practitioner registration is also available to clinics that are licensed under state law.
• A doctor employed by a hospital can, in some limited circumstances, use the hospital’s registration to
prescribe to the hospital’s patients. This will be discussed in greater detail below.
Multiple Registration Requirement – A separate registration is required for each:
(1) Location: A registration is required for each site with different street address
Example: A chain pharmacy may have thousands of pharmacies, all owned by the same corporation. Each
pharmacy location has its own DEA number, even though all locations share the same owner.
(2) Activity: For each activity, even if all activity is occurring at a single site. (see below for discussion of
activities that trigger need for multiple registrations at a single location).
• Example: single pharmacy could be required to have multiple DEA numbers, depending on its
activities (i.e., it needs a dispenser’s registration to dispense, but would need a separate detox
compounder registration if it compounded and provided product to a narcotic treatment program.
Activities that Trigger Multiple Registrations
1. Pharmacy as Distributor - Pharmacy must register as a controlled substances distributor if:
• It participates in joint buying activities, and is the location from which drugs are stored and shipped
to other pharmacies; or
• Its annual distribution of controlled substances to other pharmacies or practitioners exceeds five
percent (5%) of the total number of dosage units dispensed.
2. Pharmacy as Manufacturer – Pharmacy must register as a controlled substances distributor if:
• It purchases of controlled substances for purposes of repackaging for sale within the pharmacy
without a prescription or to other registrants requires registration as a manufacturer.
• It compounds for office use, if permitted under state law. (Note: Office use compounding is
considered to be manufacturing, and is NOT permitted, so this "exception" no longer has validity.)
Exam Tip: Remember that if a practitioner orders a controlled substance for office administration by
issuing a patient specific prescription, the pharmacy is acting as a dispenser when it fills that order.
Accordingly, a dispenser registration is all that is required.
3. Pharmacy as “DETOX COMPOUNDER” - Pharmacy must register as a “detox compounder” if:
• It compounds a controlled substance product for sale or distribution to a narcotic treatment program
for purposes of addiction treatment. Note that the NTP must be registered with DEA.
• Do not confuse registration requirement for detox compounders with office use compounders!
Manufacturers/wholesalers/importers/exporters/researchers register with DEA Form 225, and renew with
225a. Renewal is every 3 years. Same multiple registration rules apply.
Denial or Revocation of Registration
DEA may deny registration if the Applicant has:
• Materially falsified information in application;

• Been convicted of a drug-related felony;
• Committed such acts as to make registration inconsistent with the public interest; or
• Has had its state license suspended, revoked or denied.
12
DEA may revoke registration for same reasons, and in addition:
• Where applicant has been subject to mandatory exclusion from participation in the Medicare or any
state health care program.
Illinois registration requirements: Some states, including Illinois, require a separate state controlled
substance registration, in addition to the DEA registration, and in addition to the pharmacy or other
practitioner's state professional license. 2
Exam Tip: If asked what type of license a pharmacy in your jurisdiction must possess in order to
dispense all prescription drugs, the answer would be: a pharmacy license, a federal DEA registration, and
a state controlled substance license or registration.
Requirements for Illinois CS registration:
• Proof of federal registration and payment of registration fee. No additional requirements.

• Registration expires on date certificate holders pharmacy license expires (i.e. March 31 on even
years).
• Denial and revocation standards are similar to federal law.
Exam Tip: Note that the practitioner’s state registration need not appear on the RX, just the DEA number.
However, the practitioner, as well as the pharmacy, must have both a DEA registration number, and a
state controlled substances license.
DEA Registration Number - Once registered, a registrant will receive a DEA registration number. A DEA
number is a series of two letters, followed by seven numerical digits.
Registrant type (first letter of DEA Number):
A/B/F/G – Hospital/Clinic/Practitioner/Teaching Institution/Pharmacy (“G” has been added for
Department of Defense practitioners).
M – Mid-Level Practitioner
• Nurse practitioners
• Physician assistants
• Optometrists
• Pharmacists
• Chiropractic, naturopaths
• Psychologists
L - Reverse Distributors
P/R – Manufacturer/Distributor/Researcher/Analytical Lab/Importer/Exporter/Reverse
Distributor/Narcotic Treatment Program
X - DEA number is for use by a practitioner in the treatment of addictions on an outpatient basis. It is
issued and used in addition to the A, B, F, or G DEA number.
Verification of DEA registration number
First letter identifies type of registration. The second letter is usually (but is not always) the first letter of the
prescriber’s last name.
• For example, a practitioner is not required to change his/her DEA number if his/her name changes.
Thus, if “Dr. Sheila Smith” obtains a DEA registration number, it could start with “AS” as the first two
letters. If later in life she married, and her name is legally changed to “Sheila Jones”, she is not
required to get a new DEA registration number. Although her last name is “Jones”, her DEA number.
would begin “AS”.
2For a list of states that require a separate state license or registration, See,
https://www.deadiversion.usdoj.gov/drugreg/reg_apps/pract_state_lic_require.htm (accessed 2/14/2019).
13
The two letters are followed by 7 numbers. The numbers follow a formula that can be used to verify the
number:
• Add digits 1, 3, and 5
• Add digits 2, 4, and 6, and multiply the sum by two.
• Add the results of the above and the last number of the summation should equal last number in the
DEA number
o Example: DEA No. AB387843n can be verified as follows:
3 + 7 + 4 = 14;
8 + 8 + 3 = 19; 19 x 2 = 38;
14 + 38 = 52
The seventh digit of the DEA number should be “2” (i.e. AB38784332). If it is not, the
number is incorrect, and fraud may be suspected.
Exam Tip: When reviewing a fact pattern, look at the letters in the DEA number. If it starts with “M”,
immediately recognize that this is a MLP, and there may be limited prescriptive authority. Conversely, if
the fact patter identifies the prescriber as a MLP, but provides a DEA number that starts with an A, B, F, or
G, you should treat the DEA number, and the Rx, as invalid.
Exam Tip: Do not assume that the numerical sequence provided in a DEA number is correct. DO THE
MATH. If the numbers are incorrect based on the formula, the DEA number, and the Rx, are invalid.
Scheduling
Controlled substances are scheduled by DEA into one of five (5) schedules, based on the medical utility of
the substances, compared to its abuse potential and addictive propensities.
Schedules established in federal law are, with limited exceptions, followed in Illinois. CS scheduling is
“automatically” made uniform with federal law thirty days after federal scheduling unless Dept. of Human
Services objects and holds hearing to place in different schedule.
Comprehensive list at http://www.deadiversion.usdoj.gov/schedules/
• Note: Some states have 6 or more schedules
There are five (5) schedules under federal law; Illinois largely follows federal law:
Schedule I: High potential for abuse, no currently acceptable medical use, and lack of accepted safety for use
under medical supervision. If used medically, must be approved by FDA and DEA under investigational
protocol.
• Heroin
• LSD
• Mescaline
• Marijuana – even “medical marijuana”; but not Marinol®
• Methaqualone
• Peyote
• Controlled substance analogs (essentially an illegal copy of a FDA/DEA approved controlled
substance)
Schedule II: Currently accepted medical use and high abuse potential, with severe psychological or physical
dependence.
• Narcotic analgesics
14
• Amphetamines and derivatives
• Barbiturates
• Examples:
o Amphetamine
o Cocaine
o Codeine Sulphate or Phosphate
o Fentanyl (Sublimaze, Duragesic, Actiq)
o Hydromorphone (Dilaudid)
o Mepridine (Demerol)
o Methylphenidate (Ritalin)
o Methadone (Dolophine)
o Morphine (MS Contin)
o Methamphetamine (Desoxyn)
o Pentobarbital (Nembutal)
o Oxycodone/APAP (Percocet)
o Oxymorphone (Numorphan)
o Secobarbital (Seconal)
o Sufentanil (Sufenta)
o Tincture of opium
o Oxycodone HCl (Oxycontin, Percodan)
o Tapentadol (Nucynta)
o Lisdexamfetamine (Vyvanse)
Hydrocodone Products – In 2014, the DEA reclassified all commercial products containing any amount of
hydrocodone from CIII to CII. Examples include:
• Hydrocodone /APAP (Vicodin, Lortab, Norco)

• Hydrocodone/ibuprofen (Vicoprofen)
Note: Pentazocine (Talwin) – If not mixed with any other substance, pentazocine is a Schedule II in Illinois;
All pentacozine products are Schedule IV under federal law.
Schedule III: Currently acceptable medical use. Abuse potential less than C-I and C-II, but abuse may be
dangerous, or lead to moderate or low physical dependence or high psychological dependence.
• Anabolic steroids have been placed in this category.

• Mainly analgesics.
• Examples:
o Acetaminophen with codeine (Empirin #3, Empirin #4; Tylenol #3 or #4)
o Anabolic steroids (Testoderm, Winstrol)
o Aprobarbital (Alurate)
o Butalbital (Butisol, Fiorinal)
 Combination products are either CIII or are not scheduled at all
• Fiorinal (butalbital w/ASA) – CIII under both Illinois and federal law.
• Fioricet and Esgic (butalbital w/APAP) – Some formulations are CIII under
Illinois and federal law. 3
o Ketamine (Ketlar)
o Paregoric
3 There is some ambiguity in Illinois law about the status of combination products that contain butalbital. The state CSA suggests that all
products that contain any amount of butalbital are schedule III, unless "specifically excepted". IDFPR and the state PMP program takes
the view that the federal exemption creates the exception, and therefore, the federal schedule prevails.
15
o Pentobarbital rectal suppository (Nembutal suppositories)
o Thiopental (Pentothal)
o Buprenorphine (Suboxone, Subutex)
o Benzphetamine (Didrex)
o Butobarbital (Soneryl)
o Butabarbital (Butisol, Butibel)
o Phendimetrazine (Plegine)
o Dihydrocodeine (Synalgos-DC)
o Thiopental (Pentothal)
GHB - schedule I or III under both Illinois and federal law (recent change):
o Gamma Hydroxybutyric Acid (GHB) - GHB, gamma hydroxybutyrate, sodium oxybate, non-
pharmaceutical is a schedule I.
o Gamma Hydroxybutyric Acid preparations – Commercially available/FDA approved drug
products (Xyrem, GHB, gamma hydroxybutyrate) are schedule III.
Schedule IV: Currently acceptable medical use and lesser abuse potential than drugs in C-III category. Abuse
may lead to only a limited physical or psychological dependence.
• Generally: Anxiolytics; sedatives

• Examples:
o Alprazolam (Xanax)
o Butorphanol (Stadol)
o Chloral Hydrate (Noctec)
o Chlordizepoxide (Librium)
o Diazepam (Valium)
o Flurazepam (Dalmane)
o Meprobamate (Equanil, Miltown)
o Oxazepam (Serax)
o Phenobarbital
o Propoxyphene (Darvon, Darvocet)
o Triazolam (Halcion)
o Zaleplon (Sonata)
o Zolpedim (Ambien)
o Clonazepam (Klonopin)
o Tenazepam (Restoril)
o Lorezepam (Ativan)
o Carisoprodol (Soma, Soprodal, Vanadom) - a muscle relaxant
o Dichloralphenazone (Midrin) - Sedative for tension relief/vascular headaches
o Fospropofol (Lusedra) - Sedative/hypnotic; note – NOT propofol (Diprivan)
o Zopiclone (Imovane) - Non-benzodiazepine hypnotic
o Tramadol (Ultram) – Synthetic Opioid Agonist
o Pemoline (Cylert)
Schedule V: Current accepted medical use and low abuse potential. Limited physical and psychological
dependence compared to C-IV substances (“Exempt” Narcotics). Limited quantities may be purchased
without a prescription. (rules outlined below)
• Mainly: Cough; Cold; Anti-diarrheals

• Examples:
o Acetaminophen with codeine elixir
o Actifed with Codeine
o Dimetane-DC
o Novahistine DH
16
o Phenergan with Codeine
o Phenergan VC with Codeine
o Robitussin A-C with Codeine
o Robitussin DAC with Codeine
o Triaminic Expectorant with Codeine
o Diphenoxylate with Atropine (Lomotil)
o Lacosamide (Vimpat) - Anti-seizure medication; neuropathic pain
o Pregabalin (Lyrica) - Anti-seizure; neuropathic pain
o Ezogabine (Potiga) – adjunctive treatment for partial-onset seizures
Products containing not more than 10* milligrams of dihydrocodeine; or any of its salts, per 100ml or per 100
grams are also considered to be CV substances (*was 100 milligrams)
Methamphetamine Precursors – not scheduled under federal law; lots of variation from state to state:
o Ephedrine (EPH) and pseudoephedrine (PSE) – Schedule V in Illinois; not scheduled under
federal; RX only in some states (not IL); restricted distribution in most states (See below for
IL rules).
General Rules for Scheduling
Short acting and/or quickly absorbed products are more prone to be abused, and will be scheduled
accordingly.
• Examples:
o barbiturates:
 Schedule II- short-acting (pentobarbital, secobarbital) – oral and injectable
 Schedule III - combination barbiturates, suppository forms of short acting
barbiturates
 Schedule IV - long acting (phenobarbital)
o amphetamines: all are in Schedule II
o Anabolic steroids are schedule III controlled substances.
Schedule IV is the entry point for newly scheduled controlled drugs; interesting but relatively useless
information (except for MPJE® purposes); reality is that drug is placed in permanent schedule by the time it is
approved for marketing.
Exempt Narcotics - Dispensing Schedule V Controlled Substances without Prescription
Illinois and Federal Law permit a pharmacy to sell certain Schedule V controlled substances without a
prescription. This category of drugs is sometimes referred to as exempt narcotics. Here are some important
points to remember:
• State and federal laws are different in several respects, with Illinois law being stricter. Many states do
not permit the sale of exempt narcotics without a prescription. Verify your state’s law before the
exam. Under federal and state law, a patient may obtain up to four (4) ounces of a CV controlled
substance without a prescription.
• In Illinois, no person shall purchase or be dispensed more than 120 milliliters or more than 120
grams of any Schedule V substance which contains codeine, dihydrocodeine, or any salts thereof, in
any 96 hour period.
Important Exam Tip: Do not confuse these rules with the rules applicable to the sale of PSE and
other Methamphetamine Precursors. EPH and PSE are NOT controlled substances under federal law,
or under the laws of some other states. Different sales rules apply!!!
17
18
Comparison of Illinois Law and Federal Law on Schedule V Substances (Exempt Narcotics)
Requirement Illinois Law Federal Law

Age 21 yrs. old 18 yrs old
Two (2) positive forms of Must provide 1 valid ID
identification required
Time Limitation at least 96 hours at least 48 hours

Records signature of purchaser, initials of purchaser, date of sale,
certification of no purchases and initials of RPh
within 96 hours, time of sale, and
signature of pharmacist
Reporting maintain records for 2 years and maintain records for two years
send copy to IDPR by 15th of next
month
Possession Limits not more than 4.5 liters per drug silent
product plus amount of product
needed for dispensing during
busiest week
Refills if RX Max of 5 refills or 6 months, No max time limit or refills

whichever comes first
Exam tip: Under IL law, only a pharmacist can “sell” an exempt narcotic. This means a pharmacist must
complete the log book, verify the age of the seller, etc. After that part of the transaction is complete, however,
anyone can ring up the sale.
Exam tip: EPH and PSE are different. Technicians can “sell” these products, including obtaining the required
identification and patient signature. Do NOT confuse the requirements applicable to the exempt narcotics
with the requirements applicable to these “methamphetamine precursors” (PSE and EPH).
Illinois PSE and EPH Laws
Both Illinois and federal law require a patient to jump through hoops to purchase most PSE and EPH
containing products without a prescription. There are quantity limitations in terms of what can be sold to an
individual patient per transaction and per month. Illinois law is stricter than federal law.
Products:
• Single entity and combination ephedrine (EPH) and pseudoephedrine (PSE) products in all forms are
C-V controlled substances.
• Product Exemptions:
o “Convenience packages” may be sold by non-pharmacy retailers so long as the requirements
of the law (ID, log books, quantity limitations, etc.) are complied with.
 Note: Convenience packages are defined as 360 mg or less of EPH or PSE or their
salts in liquid or liquid-filled capsule form.
 Targeted packages are defined as any package, including convenience packages,
containing any amount of a methamphetamine precursor.
o Dispensing pursuant to a valid prescription for PSE or EPH is exempt from these
requirements and limitations.
o (720 ILCS 648/10; 720 ILCS 570/212; 720 ILCS 570/201).
Sales Limits:
19
• No person may knowingly purchase products containing more than 7500 mg of EPH or PSE within
any 30 day period, and retailers, pharmacy operators, pharmacists and technicians may not
knowingly distribute more than 7500 mg within 30 days to any single person (720 ILCS 648/20; 720
ILCS 648/30).
• No person may knowingly purchase more than one convenience package within a 24 hour period,
and retailers, pharmacy operators, pharmacists and technicians may not knowingly distribute more
than one convenience package within a 24 hour period to any single person. (720 ILCS 648/20; 720
ILCS 648/30).
• No person may knowingly purchase more than two packages of products containing PSE or EPH
(including convenience packages) per transaction. Pharmacy operators, pharmacists and technicians
may not knowingly distribute more than two packages of products containing PSE or EPH (including
convenience packages) per transaction.
(720 ILCS 648/20; 720 ILCS 648/25).
Sales Restrictions:
• All prescription-only products containing PSE and EPH are designated as Schedule V drugs (for more
information, see “product exceptions” above). (720 ILCS 570/212).
• PSE and EPH products may only be administered, dispensed or distributed by pharmacists,
practitioners authorized to do so by the Illinois Controlled Substances Act, a pharmacy, a retail
distributor (defined as grocery store, general merchandise store, drug store, other merchandise store,
or a distributor authorized by DEA to distribute bulk quantities of List I chemicals (720 ILCS 648/15).
• Anyone who purchases PSE or EPH products must be at least 18 years old. Retailer distributors,
pharmacy operators, pharmacists and technicians may not knowingly distribute to anyone under 18.
(720 ILCS 648/20; SB 273 – 720 ILCS 648/30).
• Products containing PSE and EPH must be packaged in blister packs, with each blister containing not
more than 2 dosage units, or when the use of blister packs is technically infeasible, in unit dose
packets and contain no more than 3,000 milligrams of PSE or EPH or their salts or isomers. (720 ILCS
648/25).
• PSE products sold in pharmacies may only be distributed by a pharmacist or pharmacy technician
licensed under the Pharmacy Practice Act. (720 ILCS 648/25).
• Non-pharmacy retailers may sell convenience packages only. Convenience packages are defined as
360 mg or less of EPH or PSE or their salts in liquid or liquid-filled capsule form.
ID Requirements:
• Purchaser must provide a driver’s license or other government issued ID showing purchaser’s name,
date of birth and photograph (720 ILCS 648/20).
• It is the responsibility of any retail distributor operating a pharmacy and retail distributors in
general as well as pharmacists or pharmacy technicians involved in the transaction to verify that the
purchaser is at least 18 years old and resemble the photo on the ID. They must also verify that the
name entered into the log correspond to the name on the purchaser’s government issued ID (720
ILCS 648/25; 720 ILCS 648/30)
Recordkeeping Requirements:
• Purchasers of PSE and EPH products must sign a log including purchaser’s name and address, the
date and time of the transaction, the brand, product name and quantity of PSE / EPH distributed. The
log may be maintained in electronic format if it includes all of the above listed information. (720 ILCS
648/20; 720 ILCS 648/25). Logs must be kept confidential and maintained for not less than 2 years.
(720 ILCS 648/25; 720 ILCS 648/30).
Product Placement:
20
• All PSE and EPH products sold in pharmacies must behind the pharmacy counter and distributed by a
pharmacist or pharmacy technician licensed under the Pharmacy Practice Act. (720 ILCS 648/25).
• Convenience packages sold by retail distributors must be displayed behind store counters or in
locked case so that customers must request store employee assistance to access the products. (720
ILCS 648/30).
Key Points for Pharmacists
• Only persons aged 18 years or older may purchase PSE and EPH.
• Purchaser must present a valid driver's license or other government-issued identification showing
the person's name, date of birth, and photograph.
• Verify that the purchaser resembles the photograph on the identification presented
• Document the purchaser's name and address, date and time of transaction, brand name/product
name, and quantity purchased. Records must be kept for at least 4 years.
• Quantity of PSE or EPH that can be sold within a 30-day period must not exceed 7500 mg.
• Number of PSE or EPH targeted packages that can be sold to an individual, in one transaction, must
not exceed 2 packages.
• PSE and EPH are to be stored behind the pharmacy counter and sold by a pharmacist, pharmacy
technician or an agent of the pharmacist or the pharmacy technician.
Compounded/Combination Products
MPJE® may ask you to calculate the amount of controlled substance in a compounded product, and determine
the correct schedule for the substance.
Unless specifically excepted, or listed in another schedule, any material, compound, mixture, or preparation
containing any of the following narcotic drugs, or their salts, calculated as the free anhydrous base or alkaloid,
are placed in schedule III or schedule V, as follows:
Schedule III (720 ILCS 570/208):
• Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 mg. per dosage unit, with
an equal or greater quantity of an isoquinoline alkaloid of opium.
• Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 mg. per dosage unit, with
1 or more active, non-narcotic ingredients in recognized therapeutic amounts.
• Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 mg. per dosage
unit, with 1 or more active, non-narcotic ingredients in recognized therapeutic amounts.
• Not more than 300 mg of ethylmorphine per 100 milliliters or not more than 15 mg. per dosage unit,
with 1 or more active, non-narcotic ingredients in recognized therapeutic amounts.
• Not more than 500 mg. of opium per 100 milliliters or per 100 grams or not more than 25 mg. per
dosage unit, with 1 or more active, non-narcotic ingredients in recognized therapeutic amounts.
• Not more than 50 mg. of morphine per 100 milliliters or per 100 grams, with 1 or more active, non-
narcotic ingredients in recognized therapeutic amounts.
Schedule V:
• When combined with 1 or more active, non-narcotic ingredients in sufficient proportion to confer
upon the mixture valuable medicinal qualities other than those possessed by narcotic drugs alone,
the following are placed in schedule V: (720 ILCS 570/212)
• Not more than 200 mg. of codeine per 100 milliliters or per 100 grams.
• Federal Law- Not more than 100 mg. of dihydrocodeine per 100 milliliters or per 100 grams.
o Illinois law is stricter - In IL, if not more than 10 milligrams of dihydrocodeine; or any of its
salts, per 100ml or per 100 grams (effective 1/1/2012)
• Not more than 100 mg. of ethylmorphine per 100 milliliters or per 100 grams.
21
• Not more than 2.5 mg. of diphenoxylate and not less than 25 micrograms of atropine sulfate per
dosage unit.
• Not more than 100 mg. of opium per 100 milliliters or per 100 grams.
• Not more than 0.5 mg. of difenoxin and not less than 25 micrograms of atropine sulfate per dosage
unit.
Exam Tip: Compounded products containing any amount of dihydrcodeinone/hydrocodone should be
treated as a CII.
Exam Tip: Compounded products are NOT considered to be exempt narcotics, and always will require a
prescription.
Sample Question:
Pharmacy receives RX asking RPH to compound:
Codeine 2 grams
APAP 12 grams
Q.S. Cherry syrup 200 mL
Sig: 2 tsp q 4 hrs prn HA
Question - How often can this RX be refilled?
Answer: Two step process:

Step 1: Determine amount of codeine per 100 mL:
o Codeine:
o 2 grams/200 mL = x grams/mL
o 2000 mg/200 mL = x mg/mL
o X = 10 mg = 1,000 mg/100 mL
o < 1.8 gm/100 mL; > 200 mg /100 mL
Since it is more than 200 mg, but less than 1.8 gm, this would be a C III, refillable 5 times in 6 months.
However, you must also determine how much codeine there is per dose
Step 2: Determine amount of codeine per dose

o 10 mg/mL = x mg/10 mL
o X = 100 mg per each 10 ml (2 tsp) dose
Therefore, this RX is for a C II controlled substance, and cannot be refilled!
EXAM TIP: Occasionally, there are some strange, off the wall drugs mentioned in the exam. A list of most
controlled substances, by brand and generic name, is available on the DEA web site at
http://www.usdoj.gov/dea/pubs/scheduling.html. CAUTION: Do not attempt to memorize the entire list,
but review it and look for familiar names to learn what class they belong in, and then become generally
familiar with other names.
Ordering Controlled Substances

Schedule II Ordering (also applies to Schedule I) – DEA 222 Order Form (21 §1305.13)
Pharmacies or other registrants that order controlled substances must use DEA form 222 to order CI and II
substances. The pharmacy or other registrant will initiate the transaction by completing the DEA 222 form.
22
• Must be signed by original DEA registrant or person given power of attorney to order. Power of
Attorney is given by the DEA registrant. For example, the pharmacist-in-charge may be given power
of attorney for a particular store by a corporate chain.
• Applicants receive a maximum of 6 order form books, each containing 7 numbered blank forms.
Each form contains 10 lines. (only 1 item per line, no alterations or erasures)
• Must Include:
o Name of drug
o NDC number of drug (if available)
o Strength, package size and number of packages
o Number of lines completed
o Signature of purchaser or agent
o DEA number of pharmacy
o Date form issued
• When drugs are received, the registrant, POA, or any person designated by the registrant or POA, is
required to:
o Verify all drugs ordered have been received.
o Indicate receipt on the form.
o Date and sign the form to confirm receipt of the order.
• Items received are recorded and the signed and dated form is filed for 2 years
• If any drug not received (if, for example, the drug is out of stock), the form remains active for 60 days.
Order can be completed anytime during that 60 day period. If not received after 60 days, item is
voided, and new order must be placed in order to receive the drug.
• The form may be refused by the seller/distributor:

o If improperly completed
o Appears altered
Forms are in triplicate; copy 1 and 2 go to supplier and 3 is maintained at the pharmacy. Supplier retains
copy 1 and forwards copy 2 to DEA.
If supplier cannot supply an ordered drug, partial filling is permitted provided that remaining items are
supplied within 60 days.
Upon receipt of drugs, the number of containers received and the date of receipt are indicated on the official
order form by the registrant, the individual with power of attorney, or other pharmacist, and filed for two (2)
years.
Note: The MPJE® may ask questions based on the color of the form, instead of copy number. Here is the
information you will need:
Copy 1 - Brown (goes to the supplier)
Copy 2 - Green (goes to supplier and is forwarded to DEA)
Copy 3 - Blue (stays with the recipient)
Exam Tip: Think of it this way – start from the ground up: Copy 1 is closest to the ground, and is brown
like dirt; copy 2 is next, and is green like the grass; above the dirt and grass is the sky, which is blue; dirt
(1), grass (2) and sky (3).
Timing – The supplier is required to forward Copy 2 (green) to the “Special Agent in Charge” of the DEA in
the area in which the supplier is located by close of the month during which the order is filled. If an order is
filled by partial shipments, Copy 2 must be forwarded at the close of the month during which the final
shipment is made or the 60-day validity period expires.
23
Electronic Ordering of C-IIs
Effective summer, 2005, the DEA implemented the Controlled Substance Ordering System (“CSOS”), which
allows pharmacies to order C-I and C-II controlled substances electronically. The CSOS system is optional, but
offers many efficiencies that encourage the use of electronic ordering to replace the paper 222 forms.
DEA's CSOS program allows for secure electronic controlled substances orders without the supporting paper
DEA Form 222. Using a technology called “Public Key Infrastructure” (“PKI”), CSOS requires that each
individual purchaser enroll with DEA to acquire a CSOS digital certificate.
CSOS subscribers achieve the following benefits:
• Ordering Freedom: CSOS transactions are the only allowance for electronic ordering of Schedule I
and II controlled substances, but may also be used for Schedule III-V substances. Additionally, CSOS
has no line item limit for a single order.
• Faster Transactions: CSOS certificates contain the same identification information as DEA Form 222,
which allows for timely and accurate validation by the supplier. Faster transactions allow for just-in-
time ordering and smaller inventories.
• Accurate Orders: CSOS reduces the number of ordering errors.
• Decreased Cost: Order accuracy and decreased paper work result in a lower transaction cost.
DEA will require a one-time, independent, third-party audit of any vendor's software for CSOS purchaser or
supplier functions to certify that it performs the necessary PKI functions. McFaul said the agency would not
routinely be checking purchasers' and suppliers' systems, but that it might check a system if a concern exists
about it.
Beyond inventory and turnaround advantages, the electronic format will also accommodate the Schedules I, II,
III, IV, and V drug orders. (The paper form can be used only for Schedules I and II drugs.) The electronic
version will also allow drugs from the different schedules to be ordered on the same form. The electronic
form can hold any number of orders, in contrast to the paper form's limit of 10.
Under the rules, while the software packages may allow the purchaser simply to enter the NDC number
rather than the entire product description, the software must be able to automatically retrieve the product
description.
Acquisitions from Other Pharmacies/Dispensers
• If obtaining C-IIs from another pharmacy in an emergency situation, the ordering pharmacy prepares
the 222, and submits it to the supplying pharmacy.
• Supplying pharmacy retains original, and sends copy 2 to DEA. Thus, supplier acts as temporary
distributor.
• Transfers Between Registrants
o Returns to distributor or manufacturer is permitted by federal law.
o If returning for credit, supplier prepares form and provides copies 1 and 2 to pharmacy.
Pharmacy forwards copy 2 to DEA, and retains copy 1.
o When pharmacy closes or is sold, C-IIs are accounted for in the transaction by the
completion of official order form by the buyer, and issued to the selling pharmacy.
Examples:
24
Identify which party gets which copies under the following scenarios 4:
1. ABC pharmacy “borrows” a supply of OxyContin from a neighboring pharmacy.
Copy 1:
Copy 2:
Copy 3:
2. The pharmacy in example #1 discovers that it does not need the OxyContin. The OxyContin has not
yet arrived – it is in transit. The pharmacist calls the delivery person and tells him to go back to the
neighboring pharmacy and return the Oxy. Is it necessary to use the 222 form, or can the order be canceled?
If a 222 is required, where do the copies go:
Copy 1:
Copy 2:
Copy 3:
3. A veterinarian purchases a bottle of Ketamine from a pharmacy:

Copy 1:
Copy 2:
Copy 3:
4. A pharmacy returns a bottle of unused morphine to the manufacturer.

Copy 1:
Copy 2:
Copy 3:
Lost or Stolen Forms (21 CFR § 305.16)
• If forms are lost in transit and not received, new form should be submitted.
• Written statement should accompany all three copies of new form, stating (1) drugs were not
received, and (2) order form is presumed lost. File with copies of old (lost) form. If old form is
subsequently found, supplier is required to void it and return it to ordering pharmacy for filing.
• Loss should immediately be reported to DEA. Should specify serial numbers, if known, or if not,
identify estimated date of receipt of forms.
Lost and stolen DEA Forms 222.
• When any used or unused DEA Forms 222 are stolen or lost (other than in the course of
transmission) by any purchaser or supplier, the purchaser or supplier must immediately upon
discovery of the theft or loss, report the theft or loss to the Special Agent in Charge of the DEA in the
Divisional Office responsible for the area in which the registrant is located, stating the serial number
of each form stolen or lost.
• If the theft or loss includes any original DEA Forms 222 received from purchasers and the supplier is
unable to state the serial numbers of the DEA Forms 222, the supplier must report the date or
approximate date of receipt and the names and addresses of the purchasers.
4 Answer Key: 1. Copy 1 - neighboring pharmacy and copy 3 - ABC pharmacy; 2. Yes. Copy 1 - ABC pharmacy and copy 3 - neighboring
pharmacy; 3. No DEA form 222 required, because ketamine is not a CII; 4. Copy 1 - pharmacy and copy 3 - manufacturer. When a 222
form is required, the DEA always gets number 2
25
• If an entire book of DEA Forms 222 is lost or stolen, and the purchaser is unable to state the serial
numbers of the DEA Forms 222 in the book, the purchaser must report, in lieu of the numbers of the
forms contained in the book, the date or approximate date of issuance.
• If any unused DEA Form 222 reported stolen or lost is subsequently recovered or found, the Special
Agent in Charge of the DEA in the Divisional Office responsible for the area in which the registrant is
located must immediately be notified.
Illinois C-II Duplicate Order Requirement
• Applies only to Illinois C-I and C-II substances which are not so classified under federal law.
Presently, only one substance - Talwin® (pentazocine) - is in this category.
• Requires written order, in duplicate, containing the following information:
• name, address and DEA number of ordering registrant;
• name, address and DEA number of selling or transferring registrant;
• name of drug ordered;
• finished bulk form and strength of substance (e.g. 50 mg. tablet);
• number of units or volume in each container (e.g. 100 tablet bottle/10 ml. vial);
• number of containers ordered; and
• name and quantity per unit of the controlled substance contained in the order if not in pure form.
• Form to be signed and dated by person authorized to execute federal order form. Original to be
maintained by selling/transferring registrant, copy to be maintained by ordering registrant, both for
two years.
Ordering C-III through C-V Substances
• No special form required.

• Must maintain all records in “readily retrievable” form, so that inspection can be accomplished
efficiently.
Prescription Requirements
Content: (1) Signed and dated on the date of issuance; (2) full name and address of patient; (3) name,
address and DEA number of prescriber; (3) drug name, strength, dosage form and quantity; (4) directions for
use; (5) if written, must be in ink.
• If oral, reduced to writing by pharmacist with same information.
Illinois law does not permit pre-printed prescriptions. However, “Pre-printed” means a written RX in which
the drug name has been indicated prior to the time of issuance, including any pre-inked stamp that would be
applied to a RX blank. Computer generated or printed prescription forms are not considered to be “pre-
printed” (if they are not prepared in advance of the time that the patient is seen by the practitioner).
• Exam tip: If the questions suggests that the prescription is printed in advance of, err on the side of
saying that it cannot be filled until verified.
• Exam tip: Computer generated prescriptions that are printed out or faxed must be manually signed.
• Prescriptions sent by fax are NOT electronic prescriptions.
• Agents may prepare a CS RX for practitioner’s signature. However, neither a pharmacist nor a
technician may act as an agent of a practitioner. DEA takes the view that a pharmacy cannot provide
26
in whole, or in part, pre-populated information on a document and have that document then become
the prescription.
Persons Authorized To Issue Controlled Substance Prescriptions
• Federal law defers to state law.

• Illinois law identifies physicians, dentists, podiatrists, and veterinarians as authorized to prescribe
controlled substances. Also allows:
o PAs, Nurse practitioners
o Optometrist
o Clinical Psychologists
Prescribing under hospital DEA Number
• Exception to requirement that all practitioners have their own dispenser’s registration number.
• Interns, residents, and foreign-trained physicians may dispense, administer and prescribe controlled
substances under the registration of the hospital or other institution, provided that:
o it is done in the usual course of his professional practice;
o state law permits;
o hospital has verified that state law permits;
o prescriber is acting only within scope of his employment in the hospital;
o the hospital authorizes the prescriber to dispense or prescribe under the hospital
registration, and designates a specific internal code number for each such prescriber. The
code number shall consist of numbers, letter, or a combination, and shall be a suffix to the
hospital’s DEA number, preceded by a hyphen; and
o a current list of internal codes and the corresponding prescriber is kept by the hospital and
is made available to other registrants and law enforcement agencies for the purpose of
verifying the prescriber’s authority.
Note: Hospital residents who also practice outside of the hospital may not prescribe under the authority of
the hospital. In order to prescribe a controlled substance outside the hospital, the resident must have his/her
own individual DEA registration, or must have permission from the other hospital to use the facility’s DEA
registration.
Exam tip: There are no limitations on the prescriptive authority for a resident or other physician who is
operating under a hospital’s DEA registration. The scope of authority can be as broad as the facility’s, or
can be limited by the facility. A common misconception is that residents cannot prescribe CIIs. That is
NOT true!
Note: Hospital residents who practice outside of the hospital must have a state medical registration number,
and may not prescribe under the authority of the hospital.
Prescribing For a Legitimate Purpose (“Good Faith”)
• Prescriptions not written for legitimate treatment purposes for valid patients are illegal and may not
be dispensed. Must be for a legitimate medical purpose by a prescriber acting in the usual
course of his professional practice.
• Illinois requirement is more specific --- an order issued to an individual not in the regular course of
treatment nor part of an authorized methadone maintenance program, or legitimate research, and
which is intended to provide the individual with controlled substances sufficient to maintain that
person’s physical or psychological addiction, habitual or customary use, dependence, or diversion, is
not a prescription, and person issuing it shall be subject to penalties provided for violations of the
CSA.
• Maintenance of a person’s addiction is not a legitimate purpose for a controlled substance RX.
• Balance need for medication with risk that drug is being “diverted”
• Valid doctor/patient relationship
27
• Prescriber acting within the scope of practice
Pharmacists’ Corresponding Responsibility
• Federal law imposes responsibility for proper prescribing and dispensing on the physician, and a
corresponding responsibility on the pharmacist who fills the prescription.
• Illinois/Federal Good Faith Standard - means the dispensing of CS pursuant to a prescription which
in pharmacist’s professional judgment is lawful. In making the judgment, pharmacist shall rely on
accepted professional standards including:
o lack of consistency of doctor-patient relationship;
o frequency of prescriptions for same drug by one prescriber for a large number of patients;
o quantities beyond those normally prescribed;
o unusual dosages;
o unusual geographic distances between patient, pharmacist and prescriber; and
o consistent prescribing of habit forming drugs.
• Cash paying customers are a red flag!
Two requirements:
(1) Diagnosis that supports the prescribing of the CS. This is the "legitimate medical purpose prong.
(2) Prescriber acting in the “usual course” of practice. Look for odd fact patterns, such as internet prescribing,
lack of a physical exam, "bad" medical practice, etc. Also consider "scope of practice".
• MDs and DOs can prescribe outside area of specialization, but read fact patterns carefully.
• Dentists, veterinarians, optometrists, podiatrists - all have more limited scopes of practice.
If prescription looks questionable, in form, or based on a red flag, additional diligence is required prior to
dispensing. Not a hard stop, but requires further review, including prescriber outreach, review of PMP
database, discussion with patient, and any other steps required to resolve concerns.
EXAM TIP: Federal law does not prohibit self-prescribing of controlled substance. Federal law does not
place a limit on the quantity of controlled substance that can be written or dispensed in a single
prescription.
• Note: Illinois law is stricter. Illinois law prohibits self-prescribing of controls.
Prescribing to immediate family members – not prohibited by federal law
• Note: Illinois law allows prescribing for family members only if a "bona fide practitioner– patient
relationship" exists and appropriate records are maintained for all treatment of family members.
For non-controls, there is no prohibition against self-prescribing or prescribing to family members. When
reviewing examination questions, however, remember that the pharmacist must always exercise good faith.
This could result in refusing to fill prescriptions for controls or non-controls written for self-use, or use by a
family member, or for large quantities. The good faith requirements apply to the dispensing of all drugs, not
just controlled substances.
C-II Prescriptions
Some Key Points:
Federal and state law require written prescriptions for schedule II controlled substances (no verbal or fax
unless an exception applies).
Time limitations: Under federal law, there is no time limit is specified for filling of CII Rx’s; most states have
a specific expiration date for CII Rx’s
• IL law – A CII prescription is valid for 90 days after the date of issuance. (Used to be 7 days.) (720 ILCS
570/312 (a))
28
RX Form: In some states a special prescription form is needed. In Illinois, no special form is needed, but
there are special rules regarding the format or required elements for CII prescriptions.
Refills: CIIs are not refillable; may dispense a partial fill, and provide remaining quantity later, subject to
special rules (see below).
Quantity: There is no quantity limitation under federal law; in theory, could prescribe and dispense 1,000
tablets in a single RX.
• IL law –Each prescription is limited to a 30 day supply. (720 ILCS 570/312 (a)).
• Other states – varies significantly from state to state.
• CII – must be written numerically and in word form.
Transmitting CII prescriptions to pharmacy:
1. General rule: Original written and hand signed prescription is required (no fax or telephone
prescriptions permitted). Electronic prescriptions that comply with federal DEA requirements are also
permitted. Oral prescriptions are permitted under the following circumstances:
• An exception is made, and oral prescriptions are permitted for emergency situations:
o Federal law defines emergency as situations in which (a) immediate administration
of the CS is necessary for proper treatment; and (b) no appropriate alternative
treatment is available; and (c) it is not reasonably possible for prescriber to provide
a written prescription. Written prescription for the emergency quantity is to be
provided within one week.
o Illinois law refers to situations that might result in “loss of life” or “intense suffering”. The
quantity dispensed must be limited to the amount needed during the emergency period.
Requirements for pharmacy:
 All information required on a written prescription must be taken and written at the time
of the emergency order.
 Within 7 days after issuing an emergency prescription, the prescriber shall cause a
written prescription for the emergency quantity prescribed to be delivered to the
dispensing pharmacist.
• The prescription shall have written on its face "Authorization for Emergency
Dispensing", and the date of the emergency prescription.
• The written prescription may be delivered to the pharmacist in person, or by mail.
o “Mail box” rule – if mailed by prescriber, must be postmarked within 7 days.
• Upon receipt, the dispensing pharmacist shall attach this prescription to the
emergency oral prescription earlier received and reduced to writing. (720 ILCS
570/309.)
Note: If confirming written prescription is not timely received, the pharmacist must notify DEA and the
Illinois Department of Human Services, Office of Alcoholism and Substance Abuse, or the emergency
dispensing authority is voided.
2. Facsimile Prescriptions
• Federal law does NOT permit fax C-II prescriptions except under certain limited circumstances:
o For C-IIs, the original must be presented before the CS is dispensed. Illinois law is silent on
this issue.
o For Home Infusion Pharmacies, hospice and Long Term Care Facilities, federal law permits
the fax to serve as the original. State law is similar.
o 01/01/12 Illinois Addition update: A C-II prescription may be transmitted by facsimile by
the prescriber to the pharmacy providing the home infusion service if the substance is to be
compounded for direct administration to a patient in a private residence, long-term care
29
facility or hospice program. For patients in a certified Medicare hospice, the prescriber may
transmit a prescription via facsimile or electronically to the dispensing pharmacy. However
the prescriber must note on the prescription that it is for a hospice patient (720 ILCS
570/313 (c, c-1)).
 Note: If a home infusion pharmacy is dispensing a solid or liquid oral dosage form, or
an IV form to be injected by the patient (as opposed to infused), the original written
RX is still required.
• FAX prescriptions for C-III thru C-V substance are permitted. (720 ILCS 570/312 (b))
3. Electronic Prescriptions
o Illinois law permits electronic prescribing of controlled substances (including CII) provided that the
system used to transmit the prescription to the pharmacy complies with all federal requirements.
(720 ILCS 570/311.5)
o Lots of detail under federal requirements
o See, http://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html
o In general, the requirements are:
o The application must be able to import, display, and store the required contents of a
controlled substance prescription accurately and consistently.
o The application must be able to digitally sign and archive the controlled substance
prescription or import and archive the record that the last intermediary digitally signed.
o The application must electronically accept and store all of the information that DEA requires
to be annotated to document the dispensing of a prescription.
o The application must allow the pharmacy to limit access for the annotation, alteration (to the
extent such alteration is permitted by DEA regulations), or deletion of controlled substance
prescription information to specific individuals or roles.
o The application must have an internal audit trail that documents whenever a prescription is
received, altered, annotated, or deleted.
o The application must conduct an internal audit that identifies any potential security
problems daily and generate a report for review by the pharmacy if a problem is identified.
Many of these requirements are standard functionalities for pharmacy applications.
o The application provider must either hire a qualified third party to audit the application or
have the application reviewed and certified by an approved certification body.
 The auditor or certification body will issue a report that states whether the
application complies with DEA’s requirements and whether there are any
limitations on its use for controlled substance prescriptions. (A limited set of
prescriptions require information that may need revision of the basic prescription
standard before they can be reliably accommodated, such as hospital prescriptions
issued to staff members with an identifying suffix.)
 The application provider must give a copy of the report to pharmacies that use or
are considering use of the pharmacy application to allow them to determine
whether the application is compliant with DEA’s requirements.
o Important Note: A pharmacy cannot process electronic prescriptions for controlled substances
until its pharmacy application provider obtains a third party audit or certification review that
determines that the application complies with DEA’s requirements and the application provider gives
the audit/certification report to the pharmacy. The pharmacy may continue to use its pharmacy
application to store and process information from paper or oral controlled substances prescriptions
it receives, but the paper records must be retained.
Information that can be changed on a C-II Prescription
General: DEA defers to state laws and policies. Previously, DEA was clear that the following changes were
permitted, usually after consultation with the prescriber:
o After consultation with the prescribing practitioner, the pharmacist is permitted to change the
patient’s address, drug strength, drug quantity, and directions for use.
30
o The pharmacist is permitted to make information additions that may be provided by the patient or
bearer such as the patient’s address, and such additions should be verified. The pharmacist may also
add the dosage form to the prescription order after verification with the prescribing practitioner.
RX Date: Note that the date is not mentioned. That is because federal law does not have any expiration date
for C-II prescriptions. Since Illinois does have a 90-day expiration for C-IIs, Illinois regulators interpret the
law as prohibiting any changes to the date on a C-II prescription. This now includes adding a missing date!
Under federal law, you can add a date, but cannot change a date once it has been placed on the prescription by
the prescriber.
o The reason for this is that prescriptions are to be signed and dated on the date they are issued.
Changing a date, or adding a date other than the date of issuance, will invalidate the prescription.
Cannot change: patient’s identity, drug prescribed (except for generic substitution), the identity of the
prescriber.
Illinois Law – 77 IL ADC 3100.400 (c) - Changes in a Prescription
1) A pharmacist may not change the following components of a prescription for a Schedule II
controlled substance:
A) Date written, or add the date;
B) Name of the patient;
C) Name of the prescriber, or add a signature; and
D) Name of the drug.
2) Any other components of a prescription for a Schedule II controlled substance may be changed after
consultation with the prescriber.
Multiple/”Sequential” CII Prescriptions for Same Drug on same Date. (720 ILCS 570/312(a-5))
• A practitioner may provide individual patients with up to three (3) 30-day supply prescriptions for
the same schedule II controlled substance, written all on the same day, to be filled sequentially over
the course of 90 days. The combined effect of these multiple prescriptions is to allow the patient to
receive, over time, up to a 90-day supply of that controlled substance.
• Requirements for issuance:
o Each prescription issued is for a legitimate medical purpose by an individual practitioner
acting in the usual course of his/her professional practice.
o The individual practitioner must provide written instructions on each prescription
indicating the earliest date on which a pharmacy may fill each prescription.
o The issuance of multiple prescriptions is permissible under applicable state laws.
o The individual practitioner complies fully with all other applicable requirements under the
Controlled Substances Act and implementing regulations, as well as any additional
requirements under state law.
Note: There is no federal limit as to the amount of controlled substances a practitioner can legitimately
prescribe. However, if a registered practitioner issues multiple schedule II prescriptions, he /she is limited to
the combined effect of allowing a patient to receive, over time, up to a 90-day supply of a particular schedule
II controlled substance. Also, practitioners may be reluctant to allow a patient to have a 90 day supply of
medication all at once. This rule does not require individual practitioners to issue multiple prescriptions or
to see their patients only once every 90 days.
Exam Tip: “Post-dating” of prescriptions is strictly PROHIBITED; state and federal regulations have
always required that all prescriptions for controlled substances "be dated as of, and signed on, the
day when issued." (see, 21 CFR 1306.05(a)).
Exam Tip: This means a pharmacy CANNOT accept a prescription with a date in the future, and hold
the Rx until the date of fill, even if it was accidentally post-dated (i.e., MD wrote tomorrows date
instead of today).
NEW DEVELOPMENT
31
Review the following regulation regarding controlled substance prescription requirements. All of these
requirements now apply to ALL controlled substances, not just CIIs, unless the law states that it applies to
only CIIs.
77 IL ADC Section 2080.70 Schedule II, III, IV and V Drug Prescription Requirements
a) A dispenser may fill a prescription for a Schedule II, III, IV or V drug upon receipt of a written, electronic,
facsimile or verbal order of a physician unless otherwise specifically exempted or allowed by federal or State
law.
b) A prescription for a Schedule II, III, IV or V drug shall:
1) Be dated as of and signed on the day when issued;
2) Bear the full name and address of the patient, or in the case of veterinary treatment, the full name
and address of the animal owner, as well as the species or common name of the animal being treated;
3) Bear the full name and address of the prescriber;
4) Bear the DEA Registration number of the prescriber;
5) Have affixed to the face of the prescription the prescriber's electronic or handwritten signature,
initials, thumbprint or other biometric or electronic identification process approved by DFPR
pursuant to Section 3 of the Pharmacy Practice Act [225 ILCS 85];
6) If written, be written in ink with a pen, typewriter or computer printer or with an indelible pencil;
7) Specify the drug name, strength, dosage and form;
8) Specify the quantity of drug to be dispensed, both written and numeric;
9) Not allow a Schedule II prescription to be filled more than 90 days after the date of issue;
10) Not allow more than a 30 day supply of a Schedule II drug on any one prescription;
11) Not allow for any refills of Schedule II drugs;
12) Contain only one Schedule II drug prescription order per prescription blank;
13) Limit the maximum time allowed for a Schedule III, IV or V prescription to be filled at six months
with a maximum of five refills;
14) Allow more than one prescription order per prescription blank for a Schedule III, IV or V drug;
15) Allow electronic prescriptions in accordance with federal rules set forth in 21 CFR 1300, 1304,
1306, 1311 (2010) [720 ILCS 570/311.5]; and
16) Allow an individual physician the authority to prescribe multiple prescriptions (3 sequential 30-
day supplies) for the same Schedule II controlled substance, authorizing up to a 90-day supply [720
ILCS 570/312(a-5)].
c) In the case of an emergency, a prescriber may issue a lawful oral prescription, when failure to issue might
result in loss of life or intense suffering. The oral prescription shall include a statement concerning the
circumstances constituting the emergency for which the oral prescription was used. Within 7 days after
issuing an emergency prescription, the prescriber shall cause a written prescription for the emergency
quantity prescribed to be delivered to the dispensing pharmacist. The prescription shall comply with all
requirements of Section 309 of the Act.
d) Patient ID for Proper Filling:
1) The sex field is a verifying element of a patient ID. The patient's gender shall be entered in the sex field.
2) The birth date is a verifying element of a patient ID and needs to be entered in the birth date field
(yyyymmdd).
32
3) The final verifying element of a patient ID for an animal or individual is not a set standard. Each pharmacy
or chain may adopt its own standard. The concern is that if a standard is too rigid, the enterprise's business
activity will suffer. Any of the following may be used. If the primary choice is not available (e.g., if the patient
is an undocumented alien), another choice may be used:
A) Driver's license or equivalent, state issued ID;
B) Telephone number of the patient's residence (include area code);
C) An internal pharmacy ID system;
D) Employer ID;
E) Student ID;
F) Insurance ID.
Prescription Requirements For Schedules III, IV and V (720 ILCS 570/312)

o Content requirements are the same as for C-IIs. However, C-III, IV and V prescriptions may be
written, facsimile copies, or oral, and may be refilled with limitations.
o May be refilled. Federal and state law limit refills of C-III and C-IV prescriptions to five refills and six
months from date of issuance.
o Federal law provides that C-V prescriptions, if written, may be refilled as in accordance with
prescriber’s instructions.
o State law limits the refills for written C-V prescriptions to the same 5 times/6 months limitation
provided for C-III and C-IV prescriptions.
Partial Dispensing of Schedule II Controlled Substance Prescriptions

General Rule: CIIs are NOT refillable. However, a pharmacist may dispense a partial quantity, and may
supply the remaining quantity at a later date, subject to the following rules:
1. Unable to Supply: If at the time the RX is presented, the pharmacy is unable to supply the full
quantity, the pharmacist may dispense a partial quantity, and supply the remainder of the prescription
balance if filled within 72 hours.
Conditions:
o Pharmacist must note the quantity supplied on the front of the written
prescription, on a written record of the emergency oral prescription, or in the
electronic prescription record.
o The remaining portion may be filled within 72 hours of the first partial dispensing.
o However, if the remaining portion is not or cannot be filled within the 72 hour
period, the pharmacist must notify the prescribing practitioner, and no further
quantity may be supplied beyond 72 hours without a new prescription.
NOTE – If RX is partially filled, and remaining quantity is filled within 72 hours, patient can still pick up the
medication after 72 hours has passed.
Example: Original RX for 50 tablets of OxyContin is filled and dispensed with 20 tablets on 3/1/10. On
3/3/10, the pharmacy receives new inventory, and fills the remaining quantity. The patient is called, but
does not come to the pharmacy until 3/6/10. The pharmacy is still permitted to dispense the remaining
quantity, because it was filled within 72 hours.
Partial fills may be done whenever the pharmacy is unable to provide the full quantity.
• According to prior DEA guidance, this may mean that the pharmacy is out of stock, but can also mean
the patient does not want the full quantity (because of cost or because they are concerned they may
not tolerate the medication).
• Also, if the pharmacist has questions about the prescription, but cannot immediately reach the
prescriber, a partial fill can be used to ensure the patient has some medication, and avoid an
interruption in therapy until the prescriber can be contacted.
2. Long Term Care Facility patients and terminally ill patients
33
o Partial quantities may be dispensed at any time.
o Pharmacist must write “long term care patient” or “terminally ill” on prescription.
o For each partial fill, the date, quantity dispensed, and quantity remaining, and identification of
pharmacist, shall be recorded on back of RX, or another appropriate record, uniformly maintained
and readily retrievable.
o If procedure is followed, prescription shall be valid for 60 days.
Recent Change to Federal Law: Comprehensive Addiction and Recovery Act of 2016 (21 USC 829 (f))
Partial fills of schedule II controlled substances
(1) Partial fills. A prescription for a controlled substance in schedule II may be partially filled if—
(A) it is not prohibited by State law;
(B)the prescription is written and filled in accordance with this subchapter, regulations prescribed by the
Attorney General, and State law;
(C)the partial fill is requested by the patient or the practitioner that wrote the prescription; and
(D)the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
(2) Remaining portions
(A) In general, except as provided in subparagraph (B), remaining portions of a partially filled
prescription for a controlled substance in schedule II—
(i) may be filled; and
(ii) shall be filled not later than 30 days after the date on which the prescription is written.
(B) Emergency situations. In emergency situations, as described in subsection (a), the remaining portions of a
partially filled prescription for a controlled substance in schedule II—
(i)may be filled; and
(ii)shall be filled not later than 72 hours after the prescription is issued.
Exam Tip: As of May 2017, Illinois law has not changed, and is stricter than federal law. Partial fills
must be filled within 72 hours.
Exam Tip: Illinois also limits "unable to supply" to pharmacy out of stock situations.
For C-III, IV and V prescriptions, partial fills are permitted. Each partial fill should be recorded on RX. Six
month time limitation still applies.
Exam Tip: Partial fills are NOT counted as full refills.
• 77 IL ADC 3100.420 – partial fills are permitted within 6 months after the date on which the RX was
issued, provided that the total quantity does not exceed the total quantity prescribed, and each
partial filling is recorded in the same manner as a refilling. This rule clarifies this further by adding
that the recording of each partial fill is required, but shall not be considered a refill.
Transferring Controlled Substance Prescriptions (CS Regulations defer to 68 IL ADC 1330.720)

o Limited to one time transfer. Under federal law, a transfer of a CS RX can occur only for purposes of
refills. An original RX cannot be transferred.
o If allowable under state law, a CS may be transferred
o Once between pharmacies if pharmacies do not share a common electronic RX file.
o Pharmacies linked electronically
 Illinois and federal law are the same – may transfer up to the number of times of
refills authorized by prescriber
34
Exam Tip: Under state and federal law, only a pharmacist may transfer a CS RX, even if transfer is
done electronically. For all other prescriptions, an electronic transfer is NOT considered to be a
transfer. This may be different than what you see in practice.
Physical Transfer:
 Transferor must write VOID on face of transferred prescription, record on reverse side the name,
address and DEA number of pharmacy to which it is transferred, and the name of the pharmacist
receiving the transfer information, and record the date and name of the pharmacist transferring the
information.
 Pharmacist receiving the transfer must write “TRANSFER” on the face of the prescription, and record
(1) issuance date; (2) original number of refills authorized; (3) date of original dispensing; (4)
number of valid refills remaining; (5) pharmacy’s name, address, DEA number and original RX
number; and (6) name of transferor pharmacist.
Both the original and transferred RX must be maintained for two years. (Five years under Illinois law!)
Labels for Controlled Substance Prescriptions

 Federal law requires seven elements: (1) name and address of pharmacy; (2) patient name; (3)
prescription number; (4) date of initial dispensing; (5) name of prescriber; (6) directions for use; and
(7) cautionary statements, if any.
 Illinois law also requires the drug name, dosage and quantity.
Federal law requires all C-II, III and IV prescriptions to contain the following “transfer warning statement”:
“CAUTION: FEDERAL LAW PROHIBITS THE TRANSFER OF THIS DRUG TO ANY PERSON OTHER THAN THE
PATIENT FOR WHOM IT WAS PRESCRIBED.”
Prescription Filing Systems

Two approaches are permitted by federal law:
• Three separate files - one for C-IIs, one for C-III, IV and Vs, and one for non-controlled legend drugs.;
• Two files - one for C-IIs and one for all others; if Schedules III, IV, and V controlled substances are
filed with non-controls, the must be "readily retrievable" from the other prescription records of the
pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the
face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than
1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and
II or in the usual consecutively numbered prescription file for noncontrolled substances. However, if
a pharmacy employs a computer application for prescriptions that permits identification by
prescription number and retrieval of original documents by prescriber name, patient's name, drug
dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is
waived.
Record Keeping
Federal law provides that the following controlled substances records must be maintained for 2 years:
• Biennial inventory records, including records of newly scheduled substances since last inventory;
• Records of receipt of controlled substances (For C-IIs, the DEA 222, for all others, business invoices);
• Dispensing records;
• Records of return or disposal;
• Reports and estimates of controlled substances thefts (DEA 106); and
• Records of amounts of CS used in compounding or discarded during the process of administration.
Exam Tip: Illinois law is stricter, and requires all prescription records (dispensing and purchase
records) to be maintained for five (5) years!
Central Record Keeping
35
 With appropriate notice to DEA, pharmacies may arrange to have financial and shipping records
(such as invoices and packing slips but not executed 222 order forms) maintained at a central
location, rather than at the registered location.
 Written notification must be submitted by registered or certified mail, return receipt requested, in
triplicate, to the Special Agent in Charge of the DEA in the area in which the registrant is located. All
notifications must include the following:
o The nature of the records to be kept centrally.
o The exact location where the records will be kept.
o The name, address, DEA registration number and type of DEA registration of the registrant
whose records are being maintained centrally.
o Whether central records will be maintained in a manual, or computer readable, form.
 If DEA does not respond to the contrary within 14 days, the central record keeping request is deemed
to be approved.
 Certain records must still be maintained locally, including: (1) executed federal order forms; (2)
prescriptions; and (3) inventories.
 By electing to centralize records, registrant agrees to provide DEA with records within 48 hours of a
request, or to allow DEA to inspect the records at the centralized location without a warrant of any
kind.
Computerization of Prescription Information
 A pharmacy is permitted to use a data processing system as an alternative to the manual method for
the storage and retrieval of prescription order refill information for Schedules III, IV and V controlled
substances.
 The computer system must provide on-line retrieval of original prescription information for those
prescriptions which are currently authorized for refill. The information must include, but is not
limited to the original prescription number, date of issuance, full name and address of the patient, the
prescriber’s name, address, and DEA registration number; the name, strength, dosage form and
quantity of the controlled substance prescribed; and the total number of refills authorized by the
prescriber.
 In addition, the computer system must provide on-line retrieval of the current refill history for
Schedule III, IV, or V controlled substance prescriptions. This information must include, but is not
limited to:
o the name of the controlled substance, the date of refill, the quantity dispensed, the
dispensing pharmacist’s identification code, or name/initials for each refill, and the total
number of refills dispensed to date for that prescription. The pharmacist must verify and
document that the refill data entered into the system is correct. All computer generated
prescription/refill documentation must be stored in a separate file at the pharmacy and be
maintained for a two-year period from the dispensing date. To meet the CFR recordkeeping
requirements, the pharmacy’s computer must comply with the following guidelines:
 If the system provides a hard copy printout of each day’s controlled substance prescription refills,
each pharmacist who refilled those prescriptions shall verify their accuracy by signing and dating the
printout as he/she would sign a check or legal document.
 This printout must be provided to each pharmacy which uses the computer system within 72 hours
of the date on which the refill was dispensed. The printout must be verified and signed by each
pharmacist who dispensed the refills.
 In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file in which
each pharmacist involved in the day’s dispensing signs a statement verifying that the refill
information entered into the computer that day has been reviewed by him/her and is correct.
 A pharmacy computer system shall have the capability of printing out any refill data which the
pharmacy must maintain under the Controlled Substances Act. For example, this would include a
refill-by-refill audit trail for any specified strength and dosage form of any controlled substance, by
either brand or generic name or both, dispensed by the pharmacy. Such a printout must include:
36
o Prescribing practitioner’s name.
o Patient’s name and address.
o Quantity dispensed on each refill.
o Dispensing date for each refill.
o Name or identification code of the dispensing pharmacist.
o Original prescription number.
 In any computerized system employed by a user pharmacy, the central recordkeeping location must
be capable of providing a printout to a requesting pharmacy of the above information within 48
hours.
 In case a pharmacy's computer system experiences downtime, the pharmacy must have a back-up
procedure to document in writing refills of Schedule III, IV and V substances. This procedure must
ensure that refills are authorized by the original prescription, that the maximum number of refills
has not been exceeded, and that all required data is retained for on-line entry as soon as possible.
 A pharmacy may use only one of the two systems described (i.e., manual or computer).
 System approval is to be obtained by notifying DEA of pharmacy’s intention to use a particular
computer system. If no objection within 14 days, the pharmacy may begin using system.
Inventory Requirements
To be taken biennially, on any date within two years of the previous biennial inventory.
Requirements:
• Inventory should state whether it was taken at opening or close of business.

• Should be signed by person taking the inventory.
• Record should be filed within the pharmacy for two years. A copy need not be sent to DEA.
• The inventory may be taken in any written, typed or printed format, provided that all of the
descriptive requirements are met. If a tape recorder is used, it must be promptly transcribed and
reduced to writing.
• When new substances are scheduled, they must be inventoried on the date of official scheduling, and
filed with most recent inventory.
• For new pharmacies, it is not necessary to inventory new stock; required copies of invoices and DEA
222s will suffice.
• For C-IIs, an actual count is required. For C-III, IV and V drugs, quantities in containers of 1,000
tablets or less may be estimated, while containers of more than 1,000 units or larger must be
physically counted. (21 CFR 1304.11).
The required contents of the inventory record are:
• name of drug;
• dosage form and unit strength;
• number of units or the volume in the container; and
• number of containers.
What is counted?
• Drugs "in inventory";
• “Wasted” drugs awaiting disposal
• What about “will call”? No; those drugs are no longer in your inventory
37
In Illinois - every licensee shall conduct an annual inventory that includes an inventory with an actual count of the
inventory on hand for C-IIs and an approximate inventory for C-III, IV, and V drugs. The inventory shall be
maintained for a period of not less than 5 years.
EXAM TIP: Do not confuse this federal requirement with the controlled substance inventory that is
required under Illinois law when a pharmacy closes, or there is a change in PIC. That is a totally separate
requirement, with different record keeping and reporting. See, "Responsibilities of PIC" in the Illinois law
section of this handout.
Disposal of Controlled Substances
Three options are available:
1. Return to supplier – If the drug is a schedule II, must use form 222 (see below). For CIII through CV,
DEA recommends that the pharmacy maintain a written record showing:
 The date of the transaction.
 The name, strength, dosage form, and quantity of the controlled substance.
 The supplier or manufacturer’s name, address, and registration number.
2. Send to “Reverse Distributor”. A “reverse distributor” is an entity registered as a distributor by DEA
and under state law. However, instead of delivering drugs to a pharmacy, it takes controlled substances from
the pharmacy for disposal. Same types of records must be maintained (CII requires form 222; CIII – CV
require records identified above).
 When reverse distributor destroys the controlled substance, it must complete DEA form 41.
3. Disposal or destruction by pharmacy – disfavored by DEA, but is permitted by law. Registrant must
request DEA authorization to destroy damaged, outdated or otherwise unwanted controlled substances.
Must then complete DEA Form-41 (Registrants Inventory of Drugs Surrendered) listing all drugs to be
destroyed.
• Written request to DEA requesting permission to destroy the controlled substances, proposing a date
and method of destruction, and listing the names of at least two people who will witness the
destruction.
• The witnesses should be either a licensed physician, pharmacist, mid-level practitioner, nurse, a state
or local law enforcement officer, or other person or entity authorized by the state.
• Both documents must be received by the nearest DEA Diversion Field Office at least two weeks prior
to the proposed destruction date.
• After reviewing all available information, the DEA office will then notify the registrant in writing of
its decision. Once the controlled substances have been destroyed, signed copies of the DEA Form-41
must be forwarded to DEA.
• If the person is a registrant, he/she shall list the controlled substances which he/she desires to
dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in
his/her area. Form 41 is prepared in “quadruplicate” (i.e., 4 copies).
• The Special Agent in Charge shall authorize and instruct the applicant to dispose of the controlled
substances in one of the following manners:
o By transfer to person registered under the Act and authorized to possess the substance
o By delivery to an Agent of the Administration or to the nearest office of the Administration
o By destruction in the presence of an Agent of the Administration or other authorized person;
or
o By such other means as the Special Agent in Charge may determine to assure that the
substance does not become available to unauthorized persons.
38
• In the event that a registrant is required regularly to dispose of controlled substances, the Special
Agent in Charge may authorize the registrant to dispose of such substances without prior approval
of DEA in each instance, on the condition that (1) the registrant keep records of such disposals and
(2) file periodic reports with the Special Agent in Charge summarizing the disposals made by the
registrant. In granting such authority, the DEA Special Agent in Charge may place such conditions
as he deems proper on the disposal of controlled substances, including the method of disposal and
the frequency and detail of reports. Must also follow all of the other requirements set forth above
(witnesses, completion of form 41, etc.)
Note: If reviewing DEA form 41, note that there is an error on the form. The instructions on the form
directs the registrant to ship the drugs to be destroyed to the special agent in charge at DEA. This is
NOT correct. The form is sent to the SAIC, and the registrant should then await instructions from SAIC
re: how to proceed.
Illinois Law – DEA regulations provide an exception to DEA authorization for destruction
• Prior DEA authorization to destroy controlled substances is not necessary when an authorized
member of a state law enforcement authority or regulatory agency witnesses the destruction.
• Copies of a DEA Form-41 or state controlled substance destruction form must be forwarded to the
local DEA Diversion Office after the destruction.
• Illinois – list of companies authorized to destroy controlled substances is available through DHS
• Persons desiring to dispose of controlled substances may request assistance from the DEA Special
Agent in Charge of the area which the person is located. Registrants must use DEA Form 41.
Controlled Substance Theft or Loss (DEA Form 106 Requirements)
Notification to DEA
Within one business day of discovery of a theft or significant loss of controlled substances, a pharmacy must
contact the nearest DEA Diversion Field Office by telephone, facsimile or by a brief written message
explaining the circumstances. A pharmacy should also notify the local police as may be required by state law.
If there is a question as to whether a theft has occurred or a loss is significant, a registrant should err on the
side of caution and report it to DEA.
DEA must be notified directly. This requirement is not satisfied by reporting the theft or significant loss in
any other manner. For example, a corporation which owns/operates multiple registered sites and wishes to
channel all notifications through corporate management or any other internal department responsible for
security must still provide notice directly to DEA and keep a copy for its records.
Complete DEA Form-106
• A pharmacy shall also complete a DEA Form-106 (Report of Theft or Loss of Controlled Substances).
To obtain a DEA Form-106, contact the nearest DEA Diversion Field Office. The DEA Form-106 will
formally document the actual circumstances of the theft or significant loss and the quantities of
controlled substances involved, once this information has been determined conclusively. The
pharmacy should send the original DEA Form-106 and a copy to the DEA Diversion Field Office and
keep a copy for its records.
• The DEA Form 106 must include the following information:
o Name and address of firm (pharmacy).
o DEA registration number.
o Date of theft (or when it was discovered if known).
o Name and telephone number of local police department if notified.
o Type of theft (night break in, armed robbery, etc.).
o Listing of symbols or cost code used by pharmacy in marking containers (if any).
39
o Listing of controlled substances missing from theft or significant loss.
If Investigation Finds No Theft or Loss
If after an investigation of the circumstances surrounding the theft or significant loss it is determined that no
such theft or significant loss occurred, no DEA Form-106 need be filed. However, the registrant should notify
DEA in writing of this fact in order to resolve the initial report and explain why no DEA Form-106 was filed
regarding the incident.
Registrant’s Responsibility for Identifying "Significant Loss"
Although the CSA regulations do not define the term "significant loss," it is the responsibility of the registrant
to use his/her best judgment to take appropriate action. A significant loss depends, in large part, on the
business of the registrant and the likelihood of a rational explanation for a particular loss. What would
constitute a significant loss for a pharmacy may be as comparatively insignificant for a hospital or distributor.
Further, the loss of a small quantity of controlled substances, repeated over a of time, may indicate a
significant problem for a registrant, a problem must be reported to DEA, even though the individual amounts
of missing substances are not, in and of themselves, significant.
Registrants report a loss upon discovery. In particular, a pharmacist should be alert suspicious or
unexplained losses. Any signs of a break in, physical entry or robbery should be reported. The burden of
responsibility is on the registrant to identify what is a significant loss and make the required report to DEA.
Some factors to consider for determining significant loss include:
• The schedule of the missing items.

• The abuse potential of the missing items.
• The abuse potential in your area of the missing substance.
• The quantity missing (one tablet vs. one bottle or container).
• Is this the first time this loss has occurred? Has a similar loss occurred before?
• Was this loss reported to local law enforcement authorities?
• If there is a question as to whether a loss is significant, a registrant should err on the side of caution
and report it to DEA.
If it is determined that the loss is not significant, place a record of the occurrence in your theft and loss file for
future reference.
Note: A recent change to the Rules for the administration of the Illinois Pharmacy Practice Act require the
PIC to file a copy of the DEA 106 loss or theft report to DPR:
• Section 1330.710 Reporting Theft or Loss of Controlled Substances

• In every instance that a pharmacist-in-charge is required by federal law (21 CFR 1301.76) to file with
the U.S. Drug Enforcement Agency a Report of Theft or Loss of Controlled Substances, Form 106, a
copy shall be sent to the DPR. Failure to do so may result in discipline of the pharmacist.
If taking the MPJE in another state, check to see whether the state regulatory authority (Board of
Pharmacy, Department of Health, etc.) requires notice, and check to see if the reporting requirements
are stricter.
Note: Only need to report theft or significant loss of drugs that are scheduled under federal law. If a drug is a
controlled substance under state law, no report is needed.
Example: PSE is a CV under state law. It is not scheduled under federal law. If a case of PSE is stolen from
your pharmacy, you are NOT required to report that to DEA with DEA form 106.
Ryan Haight Online Consumer Protection Act
On October 15, 2008, the President signed into law the Ryan Haight Online Pharmacy Consumer Protection
Act of 2008, often referred to as the “Ryan Haight Act”. This law amends the CSA by adding a series of new
40
regulatory requirements and criminal provisions designed to combat the proliferation of so-called “rogue
Internet sites” that unlawfully dispense controlled substances by means of the Internet. The Ryan Haight Act
applies to all controlled substances in all schedules.
• The law provides that it is illegal under federal law to deliver, distribute, or dispense a controlled
substance by means of the Internet unless the online pharmacy holds a modification of DEA
registration authorizing it to operate as an online pharmacy. Thus, any person who knowingly or
intentionally dispenses a controlled substance by means of the Internet that does not have a
modification of DEA registration allowing such activity is in violation of 21 U.S.C. § 841(h)(1) and
subject to potential criminal prosecution and (in the case of DEA registrants) loss of DEA
registration.
Definition of an Online Pharmacy
An online pharmacy is a person, entity, or Internet site, whether in the United States or abroad, that
knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or
dispense, a controlled substance by means of the Internet. Examples of an online pharmacy include (but are
not limited to) the following:
• Any website that sells, or offers to sell, any controlled substance or a prescription therefor to a
person in the United States.
• Any person who operates such a website.
• Any person who pays a practitioner to write prescriptions for controlled substances for customers of
such a website.
• Any person who pays a pharmacy to fill prescriptions for controlled substances that were issued to
customers of such a website.
• Any pharmacy that knowingly or intentionally fills prescriptions for controlled substances that were
issued to customers of such a website.
• Any person who sends an e-mail that:
1. offers to sell a controlled substance or a prescription for a controlled substance in a manner not
authorized by the Act;
2. directs buyers to a website operating in violation of the Act;
3. or otherwise causes or facilitates the delivery, distribution, or dispensing of a controlled
substance in a manner not authorized by the Act.
Online Pharmacy Registration Exemptions
The following are exempt from the Ryan Haight Act's definition of an “online pharmacy” so long as their
activities are limited solely to the exemptions provided:
• Manufacturers or distributors registered under 21 U.S.C. § 823(a), (b), (d), or (e) who do not
dispense controlled substances to nonregistrants.
• Nonpharmacy practitioners who are registered under 21 U.S.C. § 823(f) and whose activities are
authorized by that registration, provided that any website operated by such nonpharmacy
practitioners complies with 21 C.F.R.§ 1304.50, which requires the website to post in a visible
and clear manner on its homepage, or on a page directly linked thereto in which the hyperlink is
also visible and clear on the homepage, a list of the DEA-registered nonpharmacy practitioners
who are affiliated with the website.
• Any hospital or other medical facility registered under 21 U.S.C. § 823(f) that is operated by an
agency of the United States (including the Armed Forces).
• A health care facility owned or operated by an Indian tribe or tribal organization carrying out a
contract or compact under the Indian Self-Determination and Education Assistance Act.
• Any agent or employee of any hospital or facility that is operated by an agency of the United
States, and any agent or employee of any hospital or facility owned or operated by an Indian
tribe or tribal organization carrying out a contract or compact under the Indian Self-
Determination and Education Assistance Act, provided such agent or employee is lawfully acting
41
in the usual course of business or employment, and within the scope of the official duties of such
agent or employee, with such hospital or facility, and, with respect to agents or employees of
such health care facilities only to the extent such individuals are furnishing services pursuant to
those contracts or compacts.
• Mere advertisements that do not attempt to facilitate an actual transaction involving a controlled
substance.
• A person, entity, or Internet site that is not in the United States and does not facilitate the
delivery, distribution, or dispensing of a controlled substance by means of the Internet to any
person in the United States.
• A pharmacy registered under 21 U.S.C. § 823(f) whose dispensing of controlled substances via
the Internet consists solely of "refilling prescriptions for controlled substances in schedule III, IV,
or V," as that term is defined in 21 C.F.R. § 1300.04(k). (This definition is set forth at the end of
this section.)
• A pharmacy registered under 21 U.S.C. § 823(f) whose dispensing of controlled substances via
the Internet consists solely of "filling new prescriptions for controlled substances in schedule III,
IV, or V," as that term is defined in 21 C.F.R. § 1300.04(d). (This definition is set forth at the end
of this section.)
• Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by
means of the Internet consists solely of filling prescriptions that were electronically prescribed
in a manner authorized by the CSA.
• Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by
means of the Internet consists solely of the transmission of prescription information between a
pharmacy and an automated dispensing system located in a Long Term Care Facility when the
registration of the automated dispensing system is held by that pharmacy as described in 21
C.F.R §§ 1301.17 and 1301.27 and the pharmacy is otherwise complying with the DEA
regulations.
EXAM TIP: This law is intended to address the issue of prescribing solely pursuant to an internet
consultation, and is not directed to legitimate pharmacies that also have a website. Most retail and mail order
pharmacies have websites that allow patients to order refills, including controlled substances. The Ryan-
Haight registration requirements do NOT apply to these type of pharmacies.
Miscellaneous Controlled Substance Laws
Emergency Medication Kits

Federal Law
A pharmacy may place an emergency kit with controlled substances in a non-DEA registered Long
Term Care Facility (LTCF), if the appropriate state agency or regulatory authority specifically
approves the placement and promulgates procedures that delineate:
1. The source from which the LTCF may obtain controlled substances for emergency kits and that the
source of supply is a DEA-registered hospital/clinic, pharmacy, or practitioner.
2. The security safeguards for each emergency kit stored at the LTCF, including who may have access to
the emergency kit, and specific limitation of the type and quantity of controlled substances permitted
in the kit.
3. The responsibility for proper control and accountability of the emergency kit within the LTCF,
including the requirement that the LTCF and the supplying registrant maintain complete and
accurate records of the controlled substances placed in the emergency kit, the disposition of the
controlled substances, and the requirement to take and maintain periodic physical inventories.
42
4. The emergency medical conditions under which the controlled substances may be administered to
LTCF patients, including the requirement that controlled substances be administered by authorized
personnel only as expressly authorized by an individual practitioner.
5. The prohibited activities that if violated could result in state revocation, denial, or suspension of the
privilege to supply or possess emergency kits containing controlled substances.
Illinois Law
Long term care facilities may store controlled substances in emergency medication kits if permitted by Dept
of Public Health standards for the facility’s particular level of care. The following requirements apply:
• Controlled Substances for the emergency kit must be obtained from a DEA registered hospital,
pharmacy or practitioner;
• Kits must be safeguarded per DPH standards;
• Only the Director of Nursing, Registered Nurse on duty, licensed practical nurse on duty, or
consultant pharmacist or practitioner shall have access to the CS;
• No more than 10 different controlled substances per kit, and no more than 3 single, injectable doses
of each controlled substance;
• Controlled substances from the kit may be administered only under emergency conditions defined by
DPH standards, and then only by an RN, LPN or practitioner.
• A “proof of use” sheet must be contained in the kit for each separate controlled substance included.
Entries shall be made on the proof-of-use sheet by the nursing staff or practitioner when any CS is
used from the kit. The consultant pharmacist shall receive and file for TWO years a copy of all
completed proof of use sheets.
• Whenever the kit is opened, the consultant pharmacist is to be notified within 24 hours. During any
shift that the kit is opened, a shift count shall be done each shift until the kit is closed or locked by the
consultant pharmacist. Shift counts are not required when the kit is sealed.
• The consultant pharmacist shall check the CS in the kit at least monthly and so document inside the
kit.
• Failure to comply could result in the loss of the privilege of having or placing CS in emergency
medication kits.
Narcotic Treatment Programs

Narcotic Treatment Programs must register with the DEA
“NTPs” are programs that use controlled substances for patients going through withdrawal from other
narcotics
• Methadone
• Levo-alpha-acetyl-methadol (LAAM)
• Programs engaged in the maintenance and detoxification treatment with narcotic drugs
With limited exceptions, the use of methadone and LAAM for maintenance or detoxification treatment is
limited to the Narcotic Treatment Program setting
• “Maintenance treatment”: the dispensing, for a period in excess of 21 days, of a narcotic drug or
narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like
drug
• “Detoxification treatment”: the dispensing, for a period not in excess of 21 days, of a narcotic drug in
decreasing doses to an individual in order to alleviate adverse physiological or psychological effects
43
incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of
bringing the individual to a narcotic drug-free state within such a period of time
When a patient is on methadone for detoxification, no methadone may be prescribed for analgesic purposes.
If, however, a patient is NOT undergoing maintenance or detoxification treatment, methadone may be
prescribed as an analgesic, and dispensed by any licensed pharmacy.
Ordering is limited to those drugs used in the program for maintenance and detoxification, but if general
medical problems of the addict are also being treated at the clinic, a physician may order other drugs.
The Drug Addiction Treatment Act was passed by Congress in October 2000. It waived the requirement for a
separate DEA registration as a opioid treatment program for practitioners who dispense or prescribe FDA-
approved Schedules III-V narcotic controlled substances for use in maintenance or detoxification treatment.
DEA and the Center for Substance Abuse Treatment worked jointly to develop a system for processing these
waivers, which allow physicians to provide addiction treatment in an office-based setting, thus expanding
access to treatment. To date, DEA and Center for Substance Abuse Treatment has issued 1,355 waivers.
In October 2002, the FDA approved two new buprenorphine drug products for use by physicians in office-
based settings as permitted under the Drug Addiction Treatment Act. These substances may soon also be
available to Narcotic Treatment Programs.
When prescribing buprenorphine (Subutex and Suboxone),the prescriber, in addition to his regular DEA
registration number, must also provide a specially assigned DEA registration number that starts with the
letter “X”. This indicates that the prescriber has received the waiver, and is permitted to treat addictions on
an outpatient basis.
Use of Methadone outside a Narcotic Treatment Program
 A practitioner may prescribe methadone or any other narcotic to a narcotic addict for analgesic
purposes. However, a practitioner may not prescribe methadone or any other narcotic medication
solely for the treatment of a patient's narcotic addiction. The individual must receive the narcotics at
a registered narcotic treatment program. In this case, the narcotics can be dispensed or administered
but not prescribed. (The regulations do not prohibit the prescribing, administering or dispensing of
methadone for analgesic purposes for medical conditions other than addiction.)
 A practitioner who is not part of a narcotic treatment program may administer narcotic substances
to an addicted individual to relieve that individual’s acute withdrawal symptoms while the
practitioner makes arrangements to refer the individual to a narcotic treatment program. Not more
than one day’s medication may be administered at one time. This treatment cannot last more than
three days and may not be renewed or extended.
 A hospital that has no narcotic treatment program on the premises may administer narcotics to a
drug dependent individual for either detoxification or maintenance purposes, if the individual is
being treated for a medical condition other than narcotic addiction.
Controlled Substance Prescription Monitoring Program (https://www.ilpmp.org/QandA.php)

This law replaces the old “triplicate” requirement for C-II prescriptions. Many states require that pharmacies
report their dispensing of certain controlled statements to a state “Prescription Drug Monitoring Program”.
In some states, only CII dispensing must be reported. Illinois law was recently changed, and requires
reporting of CII, III, IV and V controlled substances.
The law provides:
• Each time a Schedule II – V controlled is dispensed, the dispenser must report the dispensing activity
to the Illinois Prescription Monitoring Program (“PMP”). (720 ILCS 570/316) The information to be
reported must include:
o The patient’s name.
o The patient’s address.
44
o The patient's date of birth
o The patient's gender
o The national drug code (NDC) number of the controlled substance dispensed.
o The date the controlled substance is dispensed.
o The quantity of the controlled substance dispensed and days supply.
o The dispenser’s US Drug Enforcement Administration (DEA) registration number.
o The prescriber’s US DEA registration number.
o The dates the controlled substance prescription is filled.
o The payment type used to purchase the controlled substance (ex. Medicaid, cash, 3rd party
insurance)
o The patient location code (ex. Home, nursing home, etc) for the controlled substance other
than those filled at a retail pharmacy.
o Any additional information required by administration rule for instance that includes
information required for compliance with the criteria for electronic reporting.
o DHS may by rule require that additional information be reported, and may also require
reporting of other select drugs that are not included in Schedule II, III, IV, or V.
• The information required to be transmitted under this Section must be transmitted not later than the
end of the next business day after the date on which the controlled substance is dispensed.
• If no Schedule II, III, IV or V drug or other selected drugs, a "zero report" must be submitted no later
than the next business day.
• Willful failure to report controlled substance dispensing to the Prescription Monitoring Program may
be liable for a civil fine up to $100 per day from the time the report was required to resolution.
• Long-term care pharmacies shall transmit patient medication profiles to the Prescription Monitoring
Program monthly or more frequently if established by administrative rule. The data collected by the
Program may be used as a tool for addressing oversight requirements of long-term care facilities.
• Exemptions:
o Inpatient drug orders (hospital, LTC facility) are exempt from the reporting requirements.
o Medications dispensed from a hospital emergency room or discharge medications must be
reported if a quantity greater than a 72 hours supply is dispensed. Quantities of 72 hour
supply or less are exempt from the reporting requirement.
o Controlled substances administered in a narcotic treatment program.
o Controlled substances administered via infusion in the home, hospital, LTC facility or
hospice.
• A dispenser must transmit the information required under this Section by:
o An electronic device compatible with the receiving device of the central repository;
o A computer diskette;
o A magnetic tape; or
Note: Reporting to the PMP is mandatory, but there is no requirement that the PMP must be reviewed each
time a CS is prescribed or dispensed. 720 ILCS 570/314.5 (e).
Medication Shopping (720 ILCS 570/314.5 (a))
o Defined as a person who intentionally or fraudulently seeks or obtains any controlled substance or
prescription for a controlled substance while being supplied any controlled substance by another
prescriber or pharmacy without disclosing the fact of the existing controlled substance to the
subsequent prescriber or pharmacy.
o Medication shopping is illegal.
Pharmacy Shopping (720 ILCS 570/314.5 (b))
o It is fraud to obtain a controlled substance from a pharmacy while being supplied with any controlled
substance by another pharmacy w/o disclosing the fact of the existing controlled substance to the
pharmacy from which the subsequent controlled substance is obtained.
45
o When a person has been described as having 3 or more prescribers or 3 or more pharmacies that do
not utilize a common electronic controlled substances w/in the course of a continuous 30-day period,
the PDMP may issue an unsolicited report to the prescribers informing them of potential medication
shopping
Mailing of Controlled Substances
Permitted under U.S. Postal Regulations. IL law follows the postal regulations, and provides that Controlled
substances may be mailed if all of the following conditions are met:
• The controlled substances are not outwardly dangerous and are not likely to cause injury to a
person's life or health.
• The inner container of a parcel containing controlled substances must be marked and sealed and
be placed in a plain outer container or securely wrapped in plain paper.
• If the controlled substances consist of prescription medicines, the inner container must be
labeled to show the name and address of the pharmacy or practitioner dispensing the
prescription.
• The outside wrapper or container must be free of markings that would indicate the nature of the
contents.
46
Food Drug and Cosmetics Act
Laws Regarding Manufacture and Wholesale Distribution
The Food and Drug Administration (“FDA”) administers the federal Food, Drug and Cosmetics Act (“FDCA”),
and is responsible for regulating all aspects of the manufacturing and, to a lesser extent, wholesale
distribution of both prescription and non-prescription drugs. All drug manufacturers and repackagers are
required to register with FDA. If they fail to register, their products are deemed to be “misbranded.”
FDA focuses on regulating manufacturers of food, drugs and cosmetics and does not regulate the practice of
medicine or the practice of pharmacy. That function is left to the states. As long as pharmacy is being
practiced, as opposed to manufacturing, the FDA does not regulate pharmacies either.
The FDCA states that a pharmacy is exempt from FDA registration when it is (1) in conformance with local
law, and (2) are regularly engaged in dispensing prescription drugs or devices, upon prescription of
practitioners licensed to administer such drugs and devices to patients under their care in the course of
professional practice, and do not manufacture, prepare, propagate, “compound”, or process drugs or devices
for resale other than in the regular course of their business of dispensing or selling at retail.
There just a couple of ways that pharmacies are directly impacted by the FDCA: (1) when a pharmacy’s
compounding activities crosses the line, and they are viewed as manufacturing a new drug, as opposed to
compounding and dispensing pursuant to a prescription, and (2) when a pharmacy violates the FDCA
prohibition against marketing/selling a drug product that is “misbranded” or “adulterated”.
Finally, although FDA has authority to regulate drug wholesalers, the regulations promulgated under the
Prescription Drug Marketing Act sets forth only minimum standards, and states have the authority to impose
more stringent regulations.
Substances Regulated by FDA
Foods, including:
•dietary supplements
•bottled water
•food additives
•infant formulas
•other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects
of some meat, poultry, and egg products)
Drugs, including:
•prescription drugs (both brand-name and generic)
•non-prescription (over-the-counter) drugs
Biologics, including:
•vaccines
•blood and blood products
•cellular and gene therapy products
•tissue and tissue products
•allergenics
Medical Devices, including:

•simple items like tongue depressors and bedpans
•complex technologies such as heart pacemakers
47
•dental devices
•surgical implants and prosthetics
Electronic Products that give off radiation, including:

•microwave ovens
•x-ray equipment
•laser products
•ultrasonic therapy equipment
•mercury vapor lamps
•sunlamps
Cosmetics, including:
•color additives found in makeup and other personal care products
•skin moisturizers and cleansers
•nail polish and perfume
Veterinary Products, including:

•livestock feeds
•pet foods
•veterinary drugs and devices
Tobacco Products, including:

•cigarettes
•cigarette tobacco
•roll-your-own tobacco
•smokeless tobacco
History of Drug Regulation
MPJE Questions don’t usually refer to the names of Acts. It may in some cases be important, however, to
know (generally) the year law was enacted and effect the law had. For example:
After 1906, it was illegal to introduce drugs into interstate commerce which were:
I. Misbranded
II. Adulterated
III. Made with contaminated materials
IV. Not effective for intended purpose
A. I only
B. II only
C. All of the above
D. I, II and III only
Note: You will be able to answer this question after we have completed this section. The more important
laws are marked with an asterisk (*) below.
Until the 20th century, drugs were, primarily, regulated by state and local governments. Drugs "could be
bought and sold like any other consumer good" (US Regulatory Affairs History, Chapter 1). Regulation
became more stringent as medical technology improved and high-profile incidents highlighted the need for at
least some degree of government monitoring of these products.
48
Virus-Toxin Law of 1902
One of the first such incidents was associated with a vaccine. After patients suffered injuries from diphtheria
vaccine "contaminated with tetanus," Congress passed the Virus-Toxin law (also referred to as the Biologics
Control Act), which required licensing of biologics establishments, inspections of vaccine manufacturers, and
premarket approval of vaccines and other products (Hyman, 1998; CBER, Commemorating, 2002; CBER,
CBER Vision, 2002). This law also is referred to as the Biologics Control Act.
*Food and Drug Act of 1906

As the new century began, widely publicized reports began to highlight severe problems in our country’s food
and drug industry. One of the most dramatic of these reports was Upton Sinclair’s book, The Jungle, which
graphically illustrated problems in the nation’s meat processing industry. Samuel Hopkins Adams’ magazine
articles concerning what he called the Great American Fraud sparked similar concerns about fraudulent
patent medicines containing dangerous ingredients such as alcohol, cocaine, morphine, and opium advertised
by their makers as cures for diseases such as cancer and tuberculosis. These and other reports spurred
Congress to pass and President Theodore Roosevelt to sign the 1906 Food and Drug Act.
The 1906 Act prohibited the marketing of adulterated (meaning, contaminated) and misbranded food and
drugs. Under the Act, such products were subject to seizure by the government. However, the law did not
limit the claims a manufacturer can make with respect to their product as long as the product was correctly
identified. The Act also did not require premarket inspections and approval.
*Federal Food, Drug and Cosmetic Act [FD&C Act] of 1938

In 1937, nearly 100 people died after ingesting a product called Elixir Sulfanilamide, which was prepared
using a chemical called diethylene glycol.
Although the manufacturer technically violated the 1906 Act because the product was called an elixir (by
definition this is supposed to contain alcohol, and this product did not), the company’s failure to test the
product for safety and to label the product adequately were not violations of the law. The 1938 Act was
passed to ensure that such a tragedy would not occur again. Among other things, the 1938 Act did the
following:
• Compelled manufacturers to demonstrate to the FDA the safety of new drugs prior to marketing;
• Allowed the FDA to inspect manufacturing facilities;
• Allowed the FDA to seek injunctions from courts; and
• Provided detailed legal definitions of drug, devices, cosmetics, and labeling
*Durham-Humphrey Amendment of 1951

In 1951, the Act was amended to formally distinguish between prescription and over-the-counter drugs. Until
that time, consumers could purchase all drugs over-the-counter. Prescription drugs were required to contain
a warning that the drugs could be dispensed legally only with the authorization of a health professional.
Note: This is one law that you should know by name.
*Kefauver-Harris Amendment of 1962

Reports of birth defects in European nations caused by thalidomide, a drug about to be introduced into the
United States, highlighted the need for more FDA regulation. Among other things, the amendment requires
drug manufacturers to show the effectiveness of their products as well as its safety, to report adverse events
to the FDA, and to ensure that their advertisements to physicians disclose the risks as well as the benefits of
their products. Informed consent was required from participants in clinical studies. The FDA also was given
jurisdiction over prescription drug advertising. In addition, the agency was required to approve a regulatory
submission known as a new drug application before a company could market a new drug and be allowed to
49
issue good manufacturing practice guidelines governing how drugs were to be manufactured. Inspection of
drug manufacturers was mandated every 2 years. Note: This is another law that you should know by name.
Medical Device Amendments of 1976

The Amendments clarified the definition of device and categorized medical devices based on risk. Medical
devices were required to meet certain performance standards and mandates on recordkeeping and adverse
event reporting. The amendments revised the definition of medical device as defined in section 201(h) of the
Act and defined a device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar related article, which does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals and which is not dependent upon being
metabolized for the achievement of its primary intended purpose."
*Anti-Tampering Regulations
In 1982, 7 people died after Tylenol capsules were contaminated with cyanide. Tylenol maker Johnson &
Johnson recalled $100 million worth of the product and introduced "tamper-resistant" packaging. After
similar incidents in 1986, the company replaced capsules with caplets, which were harder to contaminate.
FDA anti-tampering regulations require that "cosmetic liquid oral hygiene products" and vaginal products,
contact lens solutions, and most over-the-counter drugs to be packaged in tamper-resistant packages.
Products’ packaging must be "distinctive by design," and the package labeling must indicate to consumers
what tamper-resistant measures are being used. The Federal Anti-Tampering Act makes tampering with
consumer products a felony punishable by up to 10 years in jail.
Tamper-resistant packaging is defined as a package that has "an indicator or barrier to entry, which, if
breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has
occurred." According to the FDA, blister packs (tablets or capsules "individually sealed in clear plastic or
plastic compartments with foil or paper backing"), film wrappers ("transparent film - wrapped securely
around the entire product container"), aerosol containers ("believed to be inherently tamper-resistant
because of their design"); tape seals; break-away caps, and foil paper or plastic pouches that "must be torn or
broken to obtain the product" are examples of anti-tampering measures.
Note: It is not important to know the name or year of this law, but you MUST be familiar with the
requirements of this law.
Orphan Drug Act of 1983

Drugs intended for the treatment of "rare diseases and conditions" may be designated orphan drugs under
the 1983 Orphan Drug Act, which was intended to help promote research on rare diseases, substance abuse
treatments, or products intended to treat diseases in third-world nations (U.S. Regulatory Affairs History,
Fundamentals of Regulatory Affairs, Chap. 1; Chap. 16, Orphan Products, p. 127).
*Prescription Drug Marketing Act (PDMA) of 1987 and Prescription Drug Amendments of 1992
The PDMA was passed by Congress in 1987 "because there were insufficient safeguards in the prescription
drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit
drugs and that a wholesale drug diversion submarket had developed that prevented effective control over, or
even routine knowledge of, the true sources of the drug." Congress also expressed concern that samples
provided to doctors were being sold to consumers rather than freely distributed as intended by drug
manufacturers.
Enacted in 1987, the Prescription Drug Marketing Act amends the FDCA to:
• Requires states to license wholesale distributors of prescription drugs.
• Ban the reimportation of prescription drugs, except by the manufacturer or for emergency use.
50
• Mandate storage, handling, and recordkeeping requirements for drug samples. A “drug sample” is
defined as “a unit of prescription drug that is not intended to be sold and is intended to promote the
sale of the drug. Samples may only be distributed by a practitioner licensed to prescribe, or to the
pharmacy of a hospital or health care entity (at the written request of a prescriber).
• Ban the trafficking in or counterfeiting of drug coupons
• Prohibit the resale of prescription drugs purchased by hospitals or health care facilities, with certain
exceptions.
The PDMA was amended in 1992. Consistent with these concerns, the PDMA requires companies to account
for disposition of drug samples and prohibits reimportation of drugs exported to other countries. Samples or
donated pharmaceutical products generally cannot be sold to consumers. If a company becomes aware that a
product has been stolen or that there is a "significant loss" of product, it should conduct an investigation and
report the situation to the FDA within 5 days.
The PDMA also impacts the distribution and storage of drugs by imposing certain requirements on
wholesalers, such as ensuring that drugs are stored securely and that wholesalers provide the name and lot
number of the drug to purchasers. According to the FDA report, wholesalers who "serve as middlemen
between drug manufacturers and prescription drug dispensers" such as CVS and other retail pharmacies are
supposed to be licensed by the states pursuant to FDA requirements.
The most recent significant development in this area is the requirement that prescription drug wholesalers
that do not qualify as an “authorized distributor of record” are required to provide a “pedigree” with each
wholesale distribution of drug. A “pedigree” is a statement of origin that identifies each prior sale, purchase,
or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.
Under the pedigree requirement, each person who is engaged in the wholesale distribution of a prescription
drug in interstate commerce, who is not the manufacturer or an authorized distributor of record for that drug,
must provide to the person who receives the drug a pedigree for that drug.
The PDMA states that an authorized distributor of record is a distributor that has an "ongoing relationship"
with a manufacturer to distribute that manufacturer’s drug products. The PDMA does not define "ongoing
relationship," but in 1999, FDA published final regulations that defines "ongoing relationship" to include a
written agreement between manufacturer and distributor.
FDA repeatedly delayed implementation of this requirement but they finally became effective on December 1,
2006.
Prescription Drug User Fee Act (PDUFA) of 1992 (reauthorized in 1997 and 2002)
Allows the FDA to accept user fees from drug and biologic companies in return for committing to review new
drug and biologic products within certain time frames. PDUFA has been credited with speeding the approval
of new products.
Nutrition Labeling and Education Act (NLEA) of 1990

The NLEA allowed the use of FDA-approved health claims on food labels and required a uniform format for
labels that includes serving size, contents, calories, nutrients, and the recommended daily allowance of
nutrients for which such daily values have been established; lists of ingredients, and the number of servings
per container. Certain foods such as those served in restaurants are exempt from these requirements.
Because of the NLEA, dietary supplement manufacturers now can make health claims without being
considered drugs.
Dietary Supplement Health and Education Act (DSHEA) of 1994
51
Dietary supplements defined as vitamins, herbs, and minerals are exempt from food additive provisions. This
means that the FDA must prove the supplements are unsafe as opposed to manufacturers' having to
demonstrate the safety of these products. DSHEA established labeling requirements, allowed "nutritional
support statements" describing the effect of a supplement, and provided for the FDA to issue good
manufacturing practice regulations for the dietary supplement industry. Before DSHEA, supplements were
regulated in the same way as foods, food ingredients, or food additives.
Good Manufacturing Practice regulations for the dietary supplement industry have recently been published.
The regulations require supplement manufacturers to submit to FDA inspections and "assure potency, purity,
and consistency in dietary supplement products".
Food and Drug Modernization Act (FDAMA) of 1997

FDAMA established fast-track approval for certain new drugs and accelerated approval for innovative devices
by exempting certain devices from premarket notification requirements. The Act also allowed the FDA to use
expert panels in the drug approval process, regulated health claims in food, reauthorized the Prescription
Drug User Fee Act, and provided federal requirements governing compounding. However, the compounding
part of this law is not being enforced by FDA because of ambiguity created by certain federal court decisions.
Product Registration Requirements

All drug manufacturers and repackagers are required to register with FDA. If they fail to register, their
products are deemed to be “misbranded.”
Pharmacy Exemption
Pharmacy is exempt from registration when they are in conformance with local law, and are regularly
engaged in dispensing prescription drugs or devices, upon prescription of practitioners licensed to
administer such drugs and devices to patients under their care in the course of professional practice, and do
not manufacture, prepare, propagate, compound, or process drugs or devices for resale other than in the
regular course of their business of dispensing or selling at retail.
Classification of Drugs
A Drug is a substance which is:
• recognized in USP/NF or Homeopathic Pharmacopoeia;
• intended for use in diagnosis, cure, mitigation, treatment or prevention of disease;
• non-food article intended to affect structure or function of the body; or
• intended to be used as a component of an item falling within any of these categories.
Three key points:

(1) No distinction between RX or OTC.
(2) Key element is often the intent of the manufacturer or distributor.
(3) Classifications are not mutually exclusive (i.e. a substance can be both a cosmetic and a drug).
Dietary Supplements
Think of dietary supplements as “food” products. Dietary supplement makers can promote their products
using “structure function” claims, but still cannot use “drug” claims.
A dietary supplement label can say “Regular use of this product will help maintain healthy cholesterol levels”,
but cannot say” “Regular use of this product will help prevent heart disease”.
Supplement labels must also carry a disclaimer stating that the claims made on the label “have not been
evaluated or approved by the Food and Drug Administration”.
52
Prescription Drugs
General Concept: All drugs must have labeling that describes in layman’s terms how to use the drug safely
and effectively. The only exemption from this labeling requirement is if the drug cannot be made safe by
simply adding a warning or directions for use to the label. Those drugs are called “prescription drugs” or
“legend” drugs, and can be obtained lawfully only pursuant to a prescription. Thus, prescription drugs are
drugs which:
• Cannot be made safe by including adequate directions for use (and is therefore exempt from
requirement that it contain adequate directions for use or be considered misbranded).
• Medical experts agree that adequate directions for consumer self-medication cannot be provided.
• Is limited to dispensing by a prescription because it is habit forming, toxic, has a potential for harm,
or its NDA limits it to use under a doctor’s supervision.
• Label must contain “legend” stating: “Caution: Federal law prohibits dispensing without a
prescription.” (Hence the name “legend drugs”.) (Now: “Rx Only”)
EXAM TIP: For some reason, there is a need to memorize drug names – brand and OTC – and to know what
drugs require a prescription, and which are OTC. Skeletal muscle relaxants are one category of drug comes to
mind. (example: which of the following drugs is classified as a skeletal muscle relaxant?)
Also, where products are available in both RX and OTC strengths, you should know which strengths require a
prescription, and which are OTC. (Example: cimetidine and ranitidine).
Non-Prescription Drugs (“Over the Counter” or “OTC”)

Drugs which are recognized by experts to be safe and effective.
Not considered to be “misbranded” if manufactured in accordance with GMPs and labeled with instructions
for layman that indicate their safe and effective use.
Durham-Humphrey Amendments To FDCA

The drug control law most likely to be violated by the pharmacist!
Provides that prescription drugs can be dispensed:
• only upon written RX of practitioner licensed by law to administer such drugs;
• upon the practitioner’s oral RX, which is promptly reduced to writing and filed by RPh;
• by refilling where authorized by the prescriber;
• by administration directly by the prescriber.
The DHA prohibit unauthorized refills; CS have additional refill requirements.
“Prescriber” - determination of who may prescribe is made by state law.
“Prohibited Acts” - Violations of FDCA (Misbranding and Adulteration)
Misbranded Drugs
Drugs which are sold, dispensed or distributed in violation of the labeling requirements of FDCA are
misbranded.
Under federal and Illinois law, a drug is misbranded under the following circumstances:
• if it’s *labeling (see below)is false or misleading in any particular;
53
• if its packaging fails to identify the name and address of the manufacturer, packager or distributor,
and quantity of drug;
• if any word, statement or other information required by law to be on the label or labeling is not
prominent, conspicuous and readable;
• if the drug contains any quantity of a habit forming substance, and the labeling fails to identify the
name and proportion of the substance and in juxtaposition thereto the phrase “Warning - May be
habit forming”;
• if either established name or, for multi-ingredient products, each active ingredient, is not identified
on label;
• if it fails to contain “adequate directions for use” and adequate warnings, unless exempt, or fails to
contain information required by NDA;
• if not packaged and labeled in accordance with USP/NF specifications;
• if the drug is liable to deterioration, and labeling does not contain warnings to that effect;
• if it has a misleading container, imitates another drug, or is offered for sale under the same of another
drug; and
• the dosage, frequency, duration or route of administration suggested in the labeling is dangerous.
Note: “misbranding” occurs when a pharmacist dispenses without a RX or authorized refill.
EXAM TIP: Although misbranding is a concept that applies to drug manufacturers, it can also apply to
pharmacists in certain situations. Here are two common examples:
• If a pharmacist dispenses a drug without a valid prescription or an authorized refill, the product that
he dispenses is deemed to be “misbranded”.
• If a pharmacist misfills a prescription, the product that is dispensed is not supported by a valid
prescription or authorized refill, and is therefore “misbranded”.
The reason these are examples of misbranding is that there is no RX to support the dispensing, and the drug is
being sold without a valid prescription. If not supported with a prescription, the product dispensed must be
labeled with information to support its safe and effective use. The RX label does not do that (and could not do
it since, by definition, RX drugs cannot be made safe by labeling the product with directions for use and
warnings.
*Labeling is a very broad term, and includes (i) actual label; (ii) any written, printed, or graphic material
upon any container (not just immediate container); and (iii) any wrapper, or written, printed or graphic
matter accompanying the product. Labeling includes:
• package insert;
• drug advertisements;
• information in publication such as PDR; and
• promotional materials, including newsletters and literature used in promotion.
The Prescription Label

When a prescription drug is dispensed pursuant to a valid prescription, it is not required to comply with the
labeling requirements imposed on product manufacturers. However, the package prepared by the pharmacy
must satisfy the following minimum federal requirements.
(1) Name and address of dispenser (pharmacy);
(2) Serial number of prescription;
(3) Date of RX or date of filling (refer to state law);
54
(4) The name of the prescriber;
(5) Name of the patient, if stated on the prescription;
(6) Directions for use, including precautions, if any, as indicated on prescription.
Note: State laws impose additional requirements. Illinois law is stricter, and requires the drug name to
appear.
EXAM TIP: If the dispensed product is NOT supported by a valid prescription, and the container is labeled as
if dispensed pursuant to a prescription, the drug is MISBRANDED. Also, if the product is dispensed pursuant
to a valid prescription, but is dispensed without the proper RX label, it is MISBRANDED.
Adulterated Drugs
Failure of a drug or device to satisfy FDA purity standards; A drug is deemed adulterated if:
• it consists in whole or in part of any filthy, putrid, or decomposed substance; or
• it has been prepared, packed, or held under unsanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious to health; or
• it is a drug, and the methods used in, or the facilities or controls used for manufacturing, packaging,
etc. are in violation of current good manufacturing practices; or
• its container is composed, in whole or in part, of any poisonous or deleterious substance that may
render the contents injurious to health; or
• it bears an unsafe color additive for purposes of coloring only; or
• drug is labeled as if recognized in an official compendium, but differs in strength, quality or purity
from that represented
• strength or quality or purity falls below compendium standards; or
• drug is not listed in an official compendium, and its strength differs from, or its quality and purity
falls below what is represented on label; or
• any substance has been mixed with the drug to reduce the drug’s strength, or any substance has been
substituted for the drug.
EXAM TIP: Under what circumstances can a drug dispensed by a pharmacist be adulterated?
• Pharmacist drops tablet on floor, or sneezes on counting tray, and proceeds to put the drug in a vial
and dispense it to a patient. The drugs either are contaminated, or could have become contaminated,
and are adulterated.
• Fire in pharmacy – the front end of the drug store is engulfed in flames. Fire trucks arrive to put out
the fire. Smoke fills the entire store. There is high heat and humidity throughout the store.
Eventually the fire is put out. The pharmacist re-enters the store, and sees that the flames never
reached the pharmacy. He opens the door to the pharmacy, and everything looks fine. Are the drugs
adulterated??? Yes! Do you know why?
• Can you think of other examples?
EXAM TIP: Even if a drug is not dispensed, but is held for sale in the pharmacy, it can be MISBRANDED or
ADULTERATED if any of the conditions of misbranding or adulteration exist.
Example: A patient presents a prescription vial for refill, but there are no refills remaining. The
pharmacist adds a refill prior to calling the doctor, prepares the label, puts the medications into the
RX vial, and sets everything aside into another area of the pharmacy in a box that is labeled “waiting
for doctor call”. Is the product misbranded, adulterated, neither or both?
55
Good Manufacturing Practices and Compounding
“GMP” refers to the standards by which drugs are to be manufactured, processed, and packaged.
Applies to manufacturing, not compounding. However, where pharmacist crosses line between compounding
and manufacturing, FDA can apply GMPs to compounded products, along with other FDCA requirements.
“Compounding” requires the existence of a valid doctor, patient and pharmacist relationship. A doctor must
prescribe or order the compounded product for a patient in order for the pharmacist to compound. Always
look for this “triad” relationship on the MPJE. Compounding requires a patient specific prescription, or
reasonable anticipation of a patient specific prescription.
• Note: Under Illinois and federal law, pharmacies are no longer permitted to compound “for office
use” unless:
1. They have a patient specific prescription, and are simply delivering a patient specific
compounded product to the doctor’s office, or
2. Are engaged in “anticipatory compounding” and delivering the product to the office prior to,
but in anticipation of, receiving a patient specific prescription.
• Anticipatory compounding - pharmacist compounds small amounts of drug before receiving
prescription, based on previously filled valid prescriptions within an established practitioner -
patient - pharmacist relationship, and the RX is kept on file.
• Exception: Pharmacies that are registered with FDA as an “Outsourcing Facility” may engage in non-
patient specific compounding. (See discussion of 503B Outsourcing Facilities, below.)
Exam Tip: Based on this requirement, the compounding of a product for OTC sales is not permitted. FDA
would view the practice as manufacturing.
Exam Tip: Read fact patterns carefully! If there is a patient specific prescription, or facts that support
anticipatory compounding, it is lawful for the pharmacy to compound. If not, it is considered to be a form of
manufacturing, and the compounder must be registered as a manufacturer, or as an outsourcing facility.
Commercially available products: A pharmacist is permitted to compound a drug that differs slightly from
a commercially available product in response to an individual patient’s medical need that the pharmacist has
documented after consulting with the patient’s physician. This may also be permitted in the case of a drug
shortage, when the commercially available product is not available.
New federal law – Drug Quality and Security Act

Attempts to strike balance between “traditional” compounding and non-patient specific compounding.
Two parts:
(1) 503A – Traditional compounding
• If done properly, exempt from Food Drug and Cosmetics Act NDA, cGMP and labeling requirements
• Must operate in compliance with state law
• Patient specific prescription required.
(2) 503B - addresses “Outsourcing Facilities”
• Large scale compounders can elect to register with FDA as an Outsourcing facility; strictly voluntary.
• Often, but not always sterile compounding
• Key - no identifiable patient; customer is the doctor, hospital or clinic.
• If operate in compliance with 503B, exempt from NDA and labeling requirements, but must still
adhere of cGMP requirements
• cGMPs are very different from USP <797>
• Very onerous requirements
56
• FDA is supposed to implement regulations that address cGMP requirements for Outsourcing
Facilities, but has instead issued a series of guidance documents to regulate compounders
USP <797> versus CGMPs

USP <797>:
• “The United States Pharmacopeial Convention (USP) is a nonprofit scientific organization founded in
1820 in Washington, D.C., that develops and disseminates public compendial quality standards for
medicines and other articles. USP’s mission is “to improve global health through public standards and
related programs that help ensure the quality, safety, and benefit of medicines and foods.” Standards
for an article recognized in a USP compendium are expressed in the article's monograph, the General
Notices, and applicable general chapters (such as General Chapter <1> Injections). USP’s primary
compendia of standards are the United States Pharmacopeia and the National Formulary (USP–NF).
USP standards may be adapted or adopted by any organization or government worldwide. USP has
no role in enforcement; that is left to FDA and other government authorities in the U.S. and
elsewhere.” (Source: http://www.usp.org/frequently-asked-questions/usp-and-its-standards).
• USP <797> is the standard followed by 503A sterile compounding pharmacies
• Adopted by most states in pharmacy practice laws and regulations
Current Good Manufacturing Practices (CGMPs):

• “CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs
provide for systems that assure proper design, monitoring, and control of manufacturing processes
and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of
drug products by requiring that manufacturers of medications adequately control manufacturing
operations. This includes establishing strong quality management systems, obtaining appropriate
quality raw materials, establishing robust operating procedures, detecting and investigating product
quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a
pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination,
mix-ups, deviations, failures, and errors. This assures that drug products meet their quality
standards.” (Source:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm).
Repackaging OTC Products
Repackaged OTC label must contain same information as is required for commercial product:
• established name of the product, and its pharmacological category;
• name and address of the manufacturer, packer or distributor;
• net contents of product, by weight or numerical count;
• the established name of all active ingredients and quantity of certain other ingredients, whether
active or not;
• name of any habit forming drugs in the product;
• instructions for safe storage;
• cautions and warnings needed to protect the consumer; and
• adequate directions for safe and effective use.
Note: Does not apply to hospital repackaging for “own use”.
57
Removing Drugs from Market
Seizure - FDA may “seize” drugs which are “misbranded” or “adulterated.” The physical isolation of drug
while FDA or state agency files a civil lawsuit.
Recall - the correction or removal, and notification to the company, of a product which is in violation of the
law. Three levels of recall:
• Class I Recall - Reasonable probability that the use of, or exposure to, a violative product will cause
serious adverse health consequences or death.
• Class II Recall - Use of or exposure to product may cause a temporary or medically reversible adverse
health consequence, or where the probability of serious health consequences is remote.
• Class III Recall - Use of or exposure to product is not likely to cause serious adverse health
consequences.
Drug Approval Process
Step 1: in vivo animal studies

Primarily evaluate pharmacology and potential toxicities. Once complete, sponsor submits an Investigational
New Drug Application (“IND”)
Step 2: IND
Contains preclinical data, proposed use and safety data, and proposed plan for study in humans. Data
reviewed by FDA, and decision is made whether to allow sponsor to begin human trials.
Step 3: Clinical Trials - Three phases:

• Phase 1 – small group of healthy subjects receive drug; evaluation of toxicological, pharmacokinetic
and pharmacologic properties; assessment of safety of drugs in humans.
• Phase 2 – drug is given to a larger group (100 or more) of patients with the disease or symptoms of
the condition claimed to be treated by the drug; determine effectiveness and obtain information
about dosing, relative safety and adverse effects.
• Phase 3 – drug given to large groups of patients (sometimes thousands) in several geographical
locations as part of controlled clinical trials; obtain data concerning drugs effectiveness compared to
placebo; most studies are double blinded.
Once complete, results are tabulated, analyzed and then submitted as a New Drug Application (“NDA”)
Treatment IND – drug in phase 2 or 3 with some evidence of safety and effectiveness can be given to patients
that have not been enrolled in the drug’s clinical trials, and who are in imminent life-threatening stages of an
illness that has no cure, and for which presently used drugs are not effective.
Step 4: NDA
Presents to FDA reviewers the entire history of the development of the drug product. FDA reviews data and
determines whether the product meets the criteria for marketing in the U.S.
New Drug Application Process

All data concerning drug efficacy, safety, stability, production methods, packaging and data from the clinical
trials are submitted to FDA for review. FDA undertakes an exhaustive review, and if approved, the NDA is
placed on file with the FDA, and the drug can be marketed.
58
Phase 4 Studies – Post Marketing Surveillance – monitor use of drug for additional information regarding
safety and effectiveness. Manufacturer collects data, and submits yearly reports to FDA. Note: reporting of
adverse effects by health care practitioners to FDA or the manufacturer is voluntary; reporting by
manufacturer of information received is mandatory.
Abbreviated New Drug Application

Process by which generic products are approved following expiration of patent held by innovator company;
proof that the generic drug’s pharmacokinetics, bioavailability and clinical activity are similar to the
innovator product is required.
Supplemental New Drug Application

Submitted after NDA approved for changes in synthesis, production procedures, manufacturing locations,
packaging, labeling, indications, etc.
MISCELLANEOUS FDCA ISSUES
Package Insert Requirements – Estrogen Products

Federal law requires that estrogen products be dispensed with a FDA approved patient information insert.
Requirement for a patient package insert

FDA concludes that the safe and effective use of drug products containing estrogens requires that patients be
fully informed of the benefits and risks involved in the use of these drugs. Accordingly, except as provided in
paragraph (e) of this section, each estrogen drug product restricted to prescription distribution, including
products containing estrogens in fixed combinations with other drugs, shall be dispensed to patients
with a patient package insert containing information concerning the drug`s benefits and risks. An
estrogen drug product that does not comply with the requirements of this section is misbranded under
section 502(a) of the Federal Food, Drug, and Cosmetic Act.
Distribution requirements
For estrogen drug products, the manufacturer and distributor shall provide a patient package insert in or
with each package of the drug product that the manufacturer or distributor intends to be dispensed to a
patient.
In the case of estrogen drug products in bulk packages intended for multiple dispensing, and in the case of
injectables in multiple-dose vials, a sufficient number of patient labeling pieces shall be included in or with
each package to assure that one piece can be included with each package or dose dispensed or administered
to every patient. Each bulk package shall be labeled with instructions to the dispenser to include one patient
labeling piece with each package dispensed or, in the case of injectables, with each dose administered to the
patient. This section does not preclude the manufacturer or labeler from distributing additional patient
labeling pieces to the dispenser.
Patient package inserts for estrogens dispensed in acute-care hospitals or long-term care facilities will be
considered to have been provided in accordance with this section if provided to the patient before
administration of the first estrogen and every 30 days thereafter, as long as the therapy continues.
Patient package insert contents

A patient package insert for an estrogen drug product is required to contain the following information:
• The name of the drug.
• The name and place of business of the manufacturer, packer, or distributor.
• A statement regarding the benefits and proper uses of estrogens.
• The contraindications to use, i.e., when estrogens should not be used.
59
• A description of the most serious risks associated with the use of estrogens.
• A brief summary of other side effects of estrogens.
• Instructions on how a patient may reduce the risks of estrogen use.
• The date, identified as such, of the most recent revision of the patient package insert.
Exemptions
This requirement does not apply to estrogen-progestogen oral contraceptives. Labeling requirements for
these products are set forth in § 310.501 (see below).
Package Insert Requirements - Oral Contraceptives
Requirement for a patient package insert

The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the
benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the
requirements of this section is misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act.
Each dispenser of an oral contraceptive drug product shall provide a patient package insert to each patient
(or to an agent of the patient) to whom the product is dispensed, except that the dispenser may provide the
insert to the parent or legal guardian of a legally incompetent patient (or to the agent of either). The patient
package insert is required to be placed in or accompany each package dispensed to the patient.
Distribution requirements
For oral contraceptive drug products, the manufacturer and distributor shall provide a patient package insert
in or with each package of the drug product that the manufacturer or distributor intends to be dispensed to a
patient.
Patient package inserts for oral contraceptives dispensed in acute-care hospitals or long-term care facilities
will be considered to have been provided in accordance with this section if provided to the patient before
administration of the first oral contraceptive and every 30 days thereafter, as long as the therapy continues.
Contents of patient package insert

A patient package insert for an oral contraceptive drug product is required to contain the following:
• The name of the drug.
• A summary including a statement concerning the effectiveness of oral contraceptives in preventing
pregnancy, the contraindications to the drug's use, and a statement of the risks and benefits
associated with the drug's use.
• A statement comparing the effectiveness of oral contraceptives to other methods of contraception.
• A boxed warning concerning the increased risks associated with cigarette smoking and oral
contraceptive use.
• A discussion of the contraindications to use, including information that the patient should provide to
the prescriber before taking the drug.
• A statement of medical conditions that are not contraindications to use but deserve special
consideration in connection with oral contraceptive use and about which the patient should inform
the prescriber.
• A warning regarding the most serious side effects of oral contraceptives.
• A statement of other serious adverse reactions and potential safety hazards that may result from the
use of oral contraceptives.
• A statement concerning common, but less serious side effects which may help the patient evaluate
the benefits and risks from the use of oral contraceptives.
60
• Information on precautions the patients should observe while taking oral contraceptives, including
the following:
o A statement of risks to the mother and unborn child from the use of oral contraceptives
before or during early pregnancy;
 A statement concerning excretion of the drug in human milk and associated risks to
the nursing infant;
 A statement about laboratory tests which may be affected by oral contraceptives;
and
 A statement that identifies activities and drugs, foods, or other substances the
patient should avoid because of their interactions with oral contraceptives.
 Information about how to take oral contraceptives properly, including information
about what to do if the patient forgets to take the product, information about
becoming pregnant after discontinuing use of the drug, a statement that the drug
product has been prescribed for the use of the patient and should not be used for
other conditions or given to others, and a statement that the patient's pharmacist or
practitioner has a more technical leaflet about the drug product that the patient may
ask to review.
 A statement of the possible benefits associated with oral contraceptive use.
• The following information about the drug product and the patient package insert:
o The name and place of business of the manufacturer, packer, or distributor, or the name and
place of business of the dispenser of the product.
o The date, identified as such, of the most recent revision of the patient package insert placed
prominently immediately after the last section of the labeling.
• Other indications. The patient package insert may identify indications in addition to contraception
that are identified in the professional labeling for the drug product.
Ipecac Syrup
Ipecac syrup is available for sale without prescription, provided that it is packaged in a quantity of 1 fluid
ounce (30 milliliters), and its label bears the following, in a prominent and conspicuous manner:
• A statement conspicuously boxed and in red letters, to the effect: ``For emergency use to cause
vomiting in poisoning. Before using, call physician, the Poison Control Center, or hospital emergency
room immediately for advice.''
• A warning to the effect: ``Warning--Keep out of reach of children. Do not use in unconscious persons.
Ordinarily, this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong
acids, or petroleum distillates such as kerosine, gasoline, coal oil, fuel oil, paint thinner, or cleaning
fluid have been ingested.''
• Usual dosage: 1 tablespoon (15 milliliters) in persons over 1 year of age.
OTC Products Containing Salicylates

The label of any oral drug preparation intended for sale without prescription and which contains any
salicylate ingredient (including aspirin, salicylamide, other salicylates, and combinations) must conspicuously
bear, on a clearly contrasting background, the warning statement: “Keep out of reach of children [highlighted
in bold type]. In case of overdose, get medical help or contact a Poison Control Center right away”.
Such a warning statement is required for compliance with section 502(f)(2) of the Federal Food, Drug, and
Cosmetic Act and is intended to guard against accidental poisonings. Safety closures that prevent access to
the drug by young children are also recommended to guard against accidental poisonings.
Effervescent preparations and preparations containing para-aminosalicylate as the only salicylate ingredient
are exempted from this labeling requirement.
61
Aspirin tablets sold as such and containing no other active ingredients, except tablets which cannot be readily
subdivided into a child's dose because of their coating or size, should always bear dosage directions for each
age group down to 3 years of age, with a statement such as “For children under 3 years of age, consult your
physician.'' It is also recommended that:
• Aspirin tablets especially made for pediatric use be produced only in 1\1/4-grain size to reduce the
hazard of errors in dosage;
• By June 1, 1967, manufacturers and distributors of 1\1/4-grain size aspirin tablets discontinue the
distribution of such tablets in retail containers containing more than 36 tablets, to reduce the hazard
of accidental poisoning;
• The flavoring of 5-grain aspirin tablets or other “adult aspirin tablets'' be discontinued; and
• Labeling giving undue emphasis to the pleasant flavor of flavored aspirin tablets be discontinued.
It is the obligation of the distributor who labels a salicylate preparation for administration to children to
make certain that the article is suitable for such use and labeled with adequate directions for use in the age
group for which it is offered, but in no case should such an article bear directions for use in children under 3
years of age. If the directions provide for administration to children as young as 3 years of age, the label
should bear the statement, ``For children under 3 years of age consult your physician.'' However, if the
directions provide for administration to children only of an age greater than 3 years (for example, the dosage
instructions provide for administration of the article to children only down to age 6), the label should bear a
statement such as, ``For younger children consult your physician.''
A statement such as, ``For children under 3 years of age consult your physician'' or ``For younger children
consult your physician'' is not required on the label of an article clearly offered for administration to adults
only.
If the labeling or advertising of a salicylate preparation offers it for use in arthritis or rheumatism, the label
and labeling should clearly state that the beneficial effects claimed are limited to: “For the temporary relief of
minor aches and pains of arthritis and rheumatism.'' The qualifying phrase ``for the temporary relief of minor
aches and pains'' should appear with the same degree of prominence and conspicuousness as the phrase
``arthritis and rheumatism''. The label and labeling should bear in juxtaposition with such directions for use
conspicuous warning statements to the effect: ``Caution: If pain persists for more than 10 days, or redness is
present, or in conditions affecting children under 12 years of age, consult a physician immediately.'' The
salicylate dosage should not exceed 60 grains in a 24-hour period or 10 grains in a 4-hour period. If the article
contains other analgesics, the salicylate dosage should be appropriately reduced.
The labeling of orally or rectally administered over-the-counter drug products containing aspirin or
nonaspirin salicylates as active ingredients subject to this paragraph is required to prominently bear the
following warning: ``Reye's syndrome [subheading in bold type]: Children and teenagers who have or are
recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if
changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an
early sign of Reye's syndrome, a rare but serious illness.
This warning statement shall appear on the immediate container labeling. In cases where the immediate
container is not the retail package, the retail package also must bear the warning statement. In addition, the
warning statement shall appear on any labeling that contains warnings and, in such cases, the warning
statement shall be the first warning statement under the heading “Warnings.''
Over-the-counter drug products subject to this paragraph and labeled solely for use by children (pediatric
products) shall not recommend the product for use in treating flu or chicken pox.
The failure to provide the required warnings results in the product being “misbranded” under the FDCA.
62
National Drug Code (NDC) Numbers
The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug
Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or
processed by it for commercial distribution. Drug products are identified and reported using a unique, three-
segment number, called the National Drug Code (NDC), which is a universal product identifier for human
drugs.
The number is a series of 10 or 11 digits that are designed to identify the manufacturer, the drug, and the
package size.
Example: NDC Number 1234-5678-90
1234 5678 90
Manufacturer ID of Drug ID of Package
Pregnancy Warnings
Category A
Adequate, well controlled studies reveal no risk to fetus during 1st, 2nd and 3rd trimesters of pregnancy.
Category B
No adequate, well controlled studies have been conducted in pregnant women, but animal reproduction
studies have failed to demonstrate a risk to the fetus.
Category C
Safety of the drug during human pregnancy has not been established, and animal studies are either positive
for fetal risk, or have not been conducted. Drug should not be used in human females during pregnancy
unless the potential benefit outweighs the potential risk to the fetus.
Category D
There has been positive evidence of risk to the human fetus, based mainly on adverse reaction data from
investigational or marketing experience. Drug should be administered only if potential benefits to pregnant
women may be acceptable despite its potential risks.
Category X
Studies in animals, or reports in pregnant women, indicate that the risk of damage to the fetus clearly
outweighs any possible benefit to the pregnant woman.
Tamper Resistant Packaging

An OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale that is
not packaged in a tamper-resistant package or that is not properly labeled under this section is adulterated
under section 501 of the act or misbranded under section 502 of the act, or both.
In the wake of several high-profile tampering incidents involving OTC drug products, FDA instituted several
packaging, labeling, and certain manufacturing requirements in an effort to protect consumers. Historically,
the term tamper-resistant was used to describe methods used to prevent tampering. The focus is now shifted
to “tamper-evident,” to heighten consumer awareness to any evidence of tampering, rather than implying
that a particular product is difficult to breach or is tamper-proof.
With few exceptions, OTC drug products must have one or more barriers to entry that, if breached or missing
from the package, provide consumers with evidence that tampering may have occurred. Packages must
contain unique designs or other characteristics that typically cannot be duplicated. Additionally, to alert the
consumer to the specific tamper-evident features, the retail package must contain a statement that identifies
the feature, is prominently placed on the package, and is placed in a way that it will be unaffected if the
tamper-evident feature is missing or breached. For example, the statement on a bottle with a shrink band
might say, “For your protection, this bottle has an imprinted seal around the neck.”
63
OTC Monograph Info
Is developed for therapeutic classes of ingredients that are generally recognized as safe and effective (also
referred to as “GRAS/E”
No FDA approval needed by manufacture to market a product continuing an ingredient covered under an OTC
monograph.
Regulation of Alcohol
• Alcohol is regulated by the federal Bureau of Alcohol, Tobacco and Firearms.
• If you are asked about alcohol, pharmacies obtain alcohol used for compounding using form ATF-11.
• The type of alcohol sold is 95% ethanol (190 proof grain alcohol).
• This alcohol is “tax exempt”, meaning that pharmacies are not charged the federal alcohol tax when
purchasing alcohol for compounding.
64
ILLINOIS PHARMACY PRACTICE ACT
Definitions (225 ILCS 85/3)
"Pharmacy" or "drugstore" (revised) - means and includes every store, shop, pharmacy department, or other
place where pharmacist care is provided by a pharmacist:
• where drugs, medicines, or poisons are dispensed, sold or offered for sale at retail, or displayed for
sale at retail; or
• where prescriptions of physicians, dentists, advanced practice nurses, physician assistants,
veterinarians, podiatrists, or optometrists, within the limits of their licenses, are compounded, filled,
or dispensed; or
• which has upon it or displayed within it, or affixed to or used in connection with it, a sign bearing the
word or words "Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care", "Apothecary",
"Drugstore", "Medicine Store", "Prescriptions", "Drugs", "Dispensary", "Medicines", or any word or
words of similar or like import, either in the English language or any other language; or
• where the characteristic prescription sign (Rx) or similar design is exhibited; or
• any store, or shop, or other place with respect to which any of the above words, objects, signs or
designs are used in any advertisement.
"Drugs"
• articles recognized in the official USP/NF, or any supplement thereto and being intended for and
having for their main use the diagnosis, cure, mitigation, treatment or prevention of disease in
man or other animals, as approved by the FDA;
• all other articles intended for and having for their main use the diagnosis, cure, mitigation,
treatment or prevention of disease in man or other animals, as approved by the FDA;
• articles (other than food) having for their main use and intended to affect the structure or any
function of the body of man or other animals;
• articles having for their main use and intended for use as a component or any articles specified in (1),
(2) or (3);
• Does not include devices or their components, parts or accessories.
"Practice of pharmacy" (revised) - means

• the interpretation and the provision of assistance in the monitoring, evaluation, and implementation
of prescription drug orders;
• the dispensing of prescription drug orders;
• participation in drug and device selection;
• drug administration limited to the administration of oral, topical, injectable, and inhalation as
follows: in the context of patient education on the proper use or delivery of medications; vaccination
of patients 14 years of age and older pursuant to a valid prescription or standing order, by a
physician licensed to practice medicine in all its branches, upon completion of appropriate training,
including how to address contraindications and adverse reactions set forth by rule, with notification
to the patient's physician and appropriate record retention, or pursuant to hospital pharmacy and
therapeutics committee policies and procedures;
• vaccination of patients ages 10 through 13 limited to the Influenza (inactivated influenza vaccine and
live attenuated influenza intranasal vaccine) and Tdap (defined as tetanus, diphtheria, acellular
pertussis) vaccines, pursuant to a valid prescription or standing order, by a physician licensed to
practice medicine in all its branches, upon completion of appropriate training, including how to
address contraindications and adverse reactions set forth by rule, with notification to the patient's
65
physician and appropriate record retention, or pursuant to hospital pharmacy and therapeutics
committee policies and procedures;
• drug regimen review
• drug or drug-related research;
• the provision of patient counseling;
• the practice of telepharmacy;
• the provision of those acts or services necessary to provide pharmacist care;
• medication therapy management; and
• the responsibility for compounding and labeling of drugs and devices (except labeling by a
manufacturer, repackager, or distributor of non-prescription drugs and commercially packaged
legend drugs and devices), proper and safe storage of drugs and devices, and maintenance of
required records. A pharmacist who performs any of the acts defined as the practice of pharmacy in
this State must be actively licensed as a pharmacist under this Act.
EXAM TIP: You should be familiar with the types of activities that fall within the scope of the practice of
pharmacy, and be able to distinguish those activities from non-pharmacy functions. Persons assisting in
activities that fall within the scope of the “practice of pharmacy” must be pharmacists, or must be
“technicians” or “certified pharmacy technicians, and supervised by a pharmacist.
"Prescription"
• written, oral, facsimile, or electronically transmitted order for drugs or medical devices, issued by
a physician, dentist, veterinarian, or podiatrist, or optometrist, within the limits of their licenses, by
a physician assistant, or by an advanced practice nurse, containing the following:
o name of the patient;
o date when prescription was issued;
o name and strength of drug or description of the medical device prescribed; and
o quantity,
o directions for use,
o Prescriber's name, address and signature, and
o DEA number where required, for controlled substances. (except for inpatient drug orders).
Exam Tip: What types of practitioners are NOT on this list, and therefore CANNOT prescribe in
Illinois???? Chiropractors; naprapaths, physical therapists and occupational therapists; Registered
Nurses and Licensed Practical Nurses; psychologists (except certain "clinical psychologists); pharmacists
(but we will discuss “standing orders).
Prescriptions from Foreign Prescribers and U.S. Territories

Are prescription issued by prescribers licensed and located in a U.S. Territory or a foreign country valid in
Illinois?
• US Territories – Yes; US territories include Puerto Rico, Guam, and US Virgin Islands.
• Foreign Countries – No; Mexico and Canada are foreign countries.
Mid-Level Practitioner Prescriptive Authority (720 ILCS 570/303.05)

o Physician Assistant – physician may, through a written delegation of authority, delegate limited
prescriptive authority to a physician assistant; may, but not required to include prescription of Schedule
II, III, IV, or V controlled substances.
• To prescribe Schedule II, III, IV, or V controlled substances under this Section, a physician
assistant must obtain a mid-level practitioner controlled substances license.
66
• Schedule IIs:
o Specific Schedule II controlled substances by oral dosage or topical or transdermal
application may be delegated, provided that the delegated Schedule II controlled substances
are routinely prescribed by the supervising physician.
 This delegation must identify the specific Schedule II controlled substances by
either brand name or generic name. Schedule II controlled substances to be
delivered by injection or other route of administration may not be delegated
o any delegation must be of controlled substances prescribed by the supervising physician
o CII prescriptions must be limited to no more than a 30-day supply, with any continuation
authorized only after prior approval of the supervising physician
o the physician assistant must discuss the condition of any patients for whom a controlled
substance is prescribed monthly with the delegating physician
o the physician assistant must provide evidence of satisfactory completion of 45 contact hours
in pharmacology from any physician assistant program accredited by the Accreditation
Review Commission on Education for the Physician Assistant (ARC-PA), or its predecessor
agency, for any new license issued with Schedule II authority after the effective date of this
amendatory Act (i.e., 1/1/2012)
o the physician assistant must annually complete at least 5 hours of continuing education in
pharmacology
• Medication orders issued by a physician assistant shall be reviewed periodically by the
supervising physician. The supervising physician shall file with the Division of Professional
Regulation (“DPR”) notice of delegation of prescriptive authority to a physician assistant and
termination of delegation, specifying the authority delegated or terminated.
• PA must have a “written supervision agreement” with the delegating physician.
NOTE: Nothing in the law shall be construed to limit the delegation of tasks or duties by the supervising
physician to a nurse or other appropriately trained personnel.
o Advanced Practice Registered Nurse 5 –A licensed collaborating physician or collaborating podiatrist

may delegate prescriptive authority to an advanced practice registered nurse ("APRN") in accordance
with a written collaborative agreement; may but is not required to include the prescription of Schedule II,
III, IV, or V controlled substances.
• To prescribe Schedule II, III, IV, or V controlled substances under this Section, an APRN must
obtain a mid-level practitioner controlled substance license.
• The APRN has been delegated authority by a collaborating physician licensed to practice
medicine in all its branches or collaborating podiatrist to prescribe or dispense Schedule II
controlled substances through a written delegation of authority and under the following
conditions.
o Specific Schedule II controlled substances by oral, topical or transdermal application only
may be delegated, provided that the delegated Schedule II controlled substances are
routinely prescribed by the collaborating physician or podiatrist.
o This delegation must identify the specific Schedule II controlled substances by either brand
name or generic name. Schedule II controlled substances to be delivered by injection or
other route of administration may not be delegated.
o any delegation must be of controlled substances prescribed by the collaborating physician or
podiatrist;
o all prescriptions must be limited to no more than a 30-day supply, with any continuation
authorized only after prior approval of the collaborating physician or podiatrist;
5 APRNs were previously referred to as "Advanced Practice Nurses". You may see either terminology on the exam, but they mean the
same thing. They may also be referred to as "nurse practitioners".
67
o the APRN must discuss the condition of any patients for whom a controlled substance is
prescribed monthly with the delegating physician or podiatrist or in the course of review as
required by the Nurse Practice Act;
o the APRN must provide evidence of satisfactory completion of at least 45 graduate contact
hours in pharmacology for any new license issued with Schedule II authority after the
effective date of this amendatory Act (i.e., 1/1/2012)
o the APRN must annually complete 5 hours of continuing education in pharmacology
• The collaborating physician shall file with the DPR notice of delegation of prescriptive authority
and termination of such delegation.
• APRN must have a written collaborative agreement with the collaborating physician or podiatrist.
NOTE: Nothing in the law shall be construed to limit the delegation of tasks or duties by a physician to a
licensed practical nurse, a registered professional nurse, or other personnel.
Summary – APRNs and PAs:

• RX requires delegating practitioner’s name, but signature and DEA number (if controlled
substance prescribed) of the mid-level practitioner.
• To obtain MLP controlled substance license in Illinois:
o State PA or APN license number;
o License number and CS number of the delegating physician;
o A “notice of delegation of prescriptive authority”, signed by the physician indicating the
schedule of CS the MLP may prescribe or dispense.
o DEA registration and state CS license will be limited to those schedules delegated by
supervising physician.
For CIIs, only oral, topical or transdermal dosage forms may be delegated. “Oral” dosage form is defined
as “a tablet, capsule, elixir, or solution or other liquid form of medication intended for administration by
mouth, but the term does not include a form of medication intended for buccal, sublingual, or
transmucosal administration.”
New Development (Eff. 1/1/18) - Advanced Practice Registered Nurse with Full Practice Authority
An APRN who meets certain educational and clinical experience requirements are given full practice
authority, and can practice without a collaborative practice agreement.
• Must be licensed and certified as a nurse practitioner, clinical nurse specialist, or nurse midwife,
and complete 250 hours of CE and 4,000 hours of clinical experience.
• Prescriptive authority:
• Independent prescriptive authority to prescribe both legend drugs and Schedule II through
V controlled substances; this authority includes prescription of, selection of, orders for,
administration of, storage of, acceptance of samples of, and dispensing over the counter
medications, legend drugs, and controlled substances categorized as any Schedule II through
V controlled substances.
• Prescribing benzodiazepines or Schedule II narcotic drugs, such as opioids requires a
consultation relationship with a physician.
• The consultation relationship shall be recorded in the Prescription Monitoring Program
website, and is not required to be filed with the Department.
• The specific Schedule II narcotic drug must be identified by either brand name or
generic name; the specific Schedule II narcotic drug, such as an opioid, are limited to oral,
topical, or transdermal application (injectibles, transmucsal, buccal, etc. are not
permitted)
• At least monthly, the APRN and the physician must discuss the condition of any patients
for whom a benzodiazepine or opioid is prescribed.
68
Optometrist Prescriptive Authority – In recent years, changes to the law have increased the scope of
prescriptive authority for optometrists. Under prior law, only “therapeutically certified” optometrists
could prescribe, and even then the formulary was very limited.
Now, any optometrist shall be authorized to purchase diagnostic and therapeutic ocular pharmaceutical
agents and to utilize and to prescribe such drugs in the regular course of practicing optometry.
The prescribing of the drugs shall be the personal act of the optometrist and may not be delegated to any
other person.
Diagnostic and Therapeutic Authority:

• “Ocular pharmaceutical agents” means:
 Topical: anesthetics, mydriatics, cycloplegics, miotics
 Mydriatic reversing agents (topical or oral)
 Anti-infective agents (topical or oral)
 Anti-allergy agents (topical, oral, or injectable*)
 Anti-glaucoma agents (except oral carbonic anhydrase inhibitors, which may be
prescribed only in a quantity sufficient to provide treatment for up to 72 hours
 Anti-inflammatory agents (except oral steroids) (topical or oral)
 OTCs
 Analgesic agents.
o (a-5) Ocular pharmaceutical agents administered by injection may be used only for the
treatment of anaphylaxis.
o (a-10) Oral pharmaceutical agents may be prescribed for a child under 5 years of age
only in consultation with a physician licensed to practice medicine in all its branches.
o (a-15) The authority to prescribe a Schedule III, IV, or V controlled substance shall
include only analgesic agents in a quantity sufficient to provide treatment for up to 72
hours.
o The prescription of a Schedule II controlled substance is prohibited except for
Dihydrocodeinone (Hydrocodone) with one or more active, non-narcotic ingredients
only in a quantity sufficient to provide treatment for 72 hours.
Clinical Psychologist Prescriptive Authority - Clinical psychologists with special training who pass a
national certifying exam approved by the state can obtain a prescribing psychologist license.
• Must maintain a written collaborative agreement with a collaborating physician. The delegation of
prescriptive authority under the collaborative agreement may only include medications for the
treatment of mental health disease or illness the collaborating physician generally provides to his or
her patients in the normal course of his or her clinical practice with the exception of the following:
(1) patients who are less than 17 years of age or over 65 years of age; (2) patients during pregnancy;
(3) patients with serious medical conditions, such as heart disease, cancer, stroke, or seizures, and
with developmental disabilities and intellectual disabilities; and (4) prescriptive authority for
benzodiazepines that are Schedule III controlled substances.
• Any delegation of Schedule III through V controlled substances shall identify the specific controlled
substance by brand name or generic name. No controlled substance to be delivered by injection may
be delegated. No Schedule II controlled substance shall be delegated.
• Also, a prescribing psychologist shall not prescribe narcotic drugs.
"Drug product selection" means the interchange for a prescribed pharmaceutical product in accordance with
Section 25 of this Act and Section 3.14 of the Illinois Food, Drug and Cosmetic Act. (a/k/a “generic
substitution”)
69
"Inpatient drug order" means an order issued by an authorized prescriber for a resident or patient of a
nursing home (long term care facility), hospital, U of I Hospital, or a facility operated by the Department of
Human Services or the Department of Corrections.
"Pharmacist" means an individual health care professional and provider currently licensed by this State to
engage in the practice of pharmacy.
"Pharmacist in charge" means the licensed pharmacist whose name appears on a pharmacy license who is
responsible for all aspects of the operation related to the practice of pharmacy.
"Dispense" or "dispensing" (revised) - means the interpretation, evaluation, and implementation of a

prescription drug order, including the preparation and delivery of a drug or device to a patient or patient's
agent in a suitable container appropriately labeled for subsequent administration to or use by a patient in
accordance with applicable State and federal laws and regulations.
• "Dispense" or "dispensing" does not mean the physical delivery to a patient or a patient's
representative in a home or institution by a designee of a pharmacist or by common carrier.
• "Dispense" or "dispensing" also does not mean the physical delivery of a drug or medical device to a
patient or patient's representative by a pharmacist's designee within a pharmacy or drugstore while
the pharmacist is on duty and the pharmacy is open.
EXAM (and PRACTICE) TIP: When electronic data processing equipment is employed by a
pharmacy, input of drug information shall be performed by a pharmacist, or by a pharmacy
technician or a certified pharmacy technician under the supervision of a pharmacist.
"Nonresident pharmacy" “Mail-order Pharmacy” - a pharmacy located outside the state (but within a state,
commonwealth or territory of the United States other than Illinois) that ships, delivers, dispenses or
distributes any prescription substance into Illinois.
"Compounding" (revised) - means the preparation and mixing of components, excluding flavorings,
• as the result of a prescriber's prescription drug order or initiative based on the prescriber-patient-
pharmacist relationship in the course of professional practice or
• for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or
dispensing.
"Compounding" includes the preparation of drugs or devices in anticipation of receiving prescription

drug orders based on routine, regularly observed dispensing patterns. Commercially available products
may be compounded for dispensing to individual patients only if all of the following conditions are met:
(i) the commercial product is not reasonably available from normal distribution channels in a timely
manner to meet the patient's needs and (ii) the prescribing practitioner has requested that the drug be
compounded.
"Patient counseling" (revised) - "Patient counseling" means the communication between a pharmacist or a
student pharmacist under the supervision of a pharmacist and a patient or the patient's representative about
the patient's medication or device for the purpose of optimizing proper use of prescription medications or
devices. "Patient counseling" may include without limitation:
• obtaining a medication history;
• acquiring a patient's allergies and health conditions;
• facilitation of the patient's understanding of the intended use of the medication;
• proper directions for use;
• significant potential adverse events;
70
• potential food-drug interactions; and
• the need to be compliant with the medication therapy.
• A pharmacy technician may only participate in the following aspects of patient counseling under the
supervision of a pharmacist:
o obtaining medication history;
o providing the offer for counseling by a pharmacist or intern; and
o acquiring a patient's allergies and health conditions.
Exam Tip: Unlicensed persons may NOT make the offer to counsel. Also, counseling is mandatory on all
new prescriptions. An offer to counsel is permitted only for refills.
"Patient profiles"/"patient drug therapy record" means the obtaining, recording, and maintenance of patient
prescription information, including prescriptions for controlled substances, and personal information.
"Unique identifier" means an electronic signature, handwritten signature or initials, thumb print, or other
acceptable individual biometric or electronic identification process as approved by the DPR.
"Automated pharmacy system" means a mechanical system located within the confines of the pharmacy or
remote location that performs operations or activities, other than compounding or administration, relative to
storage, packaging, dispensing, or distribution of medication, and which collects, controls, and maintains all
transaction information.
"Drug regimen review" means and includes the evaluation of prescription drug orders and patient records
for:
• known allergies;
• drug or potential therapy contraindications;
• reasonable dose, duration of use, and route of administration, taking into consideration factors such
as age, gender, and contraindications;
• reasonable directions for use;
• potential or actual adverse drug reactions;
• drug-drug interactions;
• drug-food interactions;
• drug-disease contraindications;
• therapeutic duplication;
• patient laboratory values when authorized and available;
• proper utilization (including over or under-utilization) and optimum therapeutic outcomes; and
• abuse and misuse.
Note: under the old Act, these activities were referred to as “drug utilization review”.
"Electronically transmitted prescription" means a prescription that is created, recorded, or stored by

electronic means; issued and validated with an electronic signature; and transmitted by electronic means
directly from the prescriber to a pharmacy. An electronic prescription is not an image of a physical
prescription that is transferred by electronic means from computer to computer,
facsimile to facsimile, or facsimile to computer.
"Medication therapy management services" means a distinct service or group of services offered by licensed
pharmacists, physicians licensed to practice medicine in all its branches, advanced practice nurses authorized
71
in a written agreement with a physician licensed to practice medicine in all its branches, or physician
assistants authorized in guidelines by a supervising physician that optimize therapeutic outcomes for
individual patients through improved medication use. In a retail or other non-hospital pharmacy, medication
therapy management services shall consist of the evaluation of prescription drug orders and patient
medication records to resolve conflicts with the following:
• known allergies;
• drug or potential therapy contraindications;
• reasonable dose, duration of use, and route of administration, taking into consideration factors such
as age, gender, and contraindications;
• reasonable directions for use;
• potential or actual adverse drug reactions;
• drug-drug interactions;
• drug-food interactions;
• drug-disease contraindications;
• identification of therapeutic duplication;
• patient laboratory values when authorized and available;
• proper utilization (including over or under-utilization) and optimum therapeutic outcomes; and
• drug abuse and misuse.
"Medication therapy management services" includes the following:

• documenting the services delivered and communicating the information provided to patients'
prescribers within an appropriate time frame, not to exceed 48 hours;
• providing patient counseling designed to enhance a patient's understanding and the appropriate use
of his or her medications; and
• providing information, support services, and resources designed to enhance a patient's adherence
with his or her prescribed therapeutic regimens.
"Medication therapy management services" may also include patient care functions authorized by a
physician licensed to practice medicine in all its branches for his or her identified patient or groups of
patients under specified conditions or limitations in a standing order from the physician.
"Medication therapy management services" in a licensed hospital may also include the following:
o reviewing assessments of the patient's health status; and
o following protocols of a hospital pharmacy and therapeutics committee with respect to the
fulfillment of medication orders.
"Pharmacist care" means the provision by a pharmacist of medication therapy management services, with or
without the dispensing of drugs or devices, intended to achieve outcomes that improve patient health, quality
of life, and comfort and enhance patient safety.
"Protected health information" means individually identifiable health information that, except as otherwise
provided, is:
• transmitted by electronic media;
• maintained in any medium set forth in the definition of "electronic media" in the federal Health
Insurance Portability and Accountability Act; or
• transmitted or maintained in any other form or medium.
72
"Protected health information" does not include individually identifiable health information found in:
• education records covered by the federal Family Educational Right and Privacy Act; or
• employment records held by a licensee in its role as an employer.
"Standing order" means a specific order for a patient or group of patients issued by a physician licensed to
practice medicine in all its branches in Illinois.
o NOTE: This is what gives pharmacists a form of “prescriptive authority”. However, RX that is issued is
still in the name of the doctor as the prescriber. Note also need to comply with "MTM" requirements.
"Address of record" means the address recorded by the Department in the applicant's or licensee's
application file or license file, as maintained by the Department's licensure maintenance unit.
"Email address of record" means the designated email address recorded by the Department in the applicant's
application file or the licensee's license file, as maintained by the Department's licensure maintenance unit.
Exam tip: Illinois law now requires applicants and licensees to (1) provide a valid address and email
address to the Department, which shall serve as the address of record and email address of record,
respectively, at the time of application for licensure or renewal of a license; and (2) inform the
Department of any change of address of record or email address of record within 14 days after such
change either through the Department's website or by contacting the Department's licensure
maintenance unit.
"Home pharmacy" means the location of a pharmacy's primary operations.
Illinois Department of Financial and Professional Regulation (“DFPR”),

Division of Professional Regulation (“DPR”) and the Illinois Board of Pharmacy
The Department of Financial and Professional Regulation and the Board of Pharmacy jointly regulate the
practice of pharmacy. The Division of Professional Regulation is a sub-unit of DFPR, and is the unit that
regulates pharmacy.
Function
• DFPR regulates all professions and occupations in Illinois, including pharmacy.
• Enforces the Pharmacy Practice Act, with the assistance of the Board of Pharmacy.
• Has quasi-executive, quasi-legislative and quasi-judicial powers.
• Administers Act with assistance of Board of Pharmacy.
Powers - With Action and Written Report from Board:
• Rulemaking: Formulate rules for the administration of the Pharmacy Practice Act;
• Discipline: Suspend, revoke, censure, place on probation, reprimand, or refuse to issue or restore
any license or certificate for reasons stated in the Act;
• Licensing: Issue, renew, restore or reissue any license which had previously been refused issuance
or renewal, revoked, suspended, or placed on probation;
• Variances: Grant variances from rules promulgated under the Act where there is a finding (1) that
the provision from which a variance is requested is not statutorily mandated, (2) that no party may
be injured by granting of the variance, and (3) the rule from which the variance is granted would be
unreasonable or unnecessarily burdensome as applied.
Board of Pharmacy
73
Composition, Qualifications and Appointment Process
• Nine (9) members - Seven (7) licensed pharmacists and two (2) non-pharmacist public members.
• Public members cannot be engaged in any way, directly or indirectly, as providers of health care.
• Pharmacist members must be licensed and in good standing, a graduate of an accredited college of
pharmacy or hold a BS in Pharmacy, and have at least five (5) years of post-licensure experience as a
licensed pharmacist in the state of Illinois.
• Appointed by Governor, with due consideration given to recommendations by members of the
profession and pharmacy professional organizations. Shall give consideration to individuals in all
types and settings of pharmacy practice.
• 5 year terms.
o No member can serve for more than 2 full terms in their lifetime.
o Governor may remove any member for misconduct, incapacity, or neglect of duty, and is
the sole judge of the sufficiency of the cause for removal.
o Meets quarterly with annual meeting in January of each year.
o Five members shall constitute quorum for transaction of business.
Powers and Duties

In general - the Board shall exercise the rights, powers and duties vested under the Act or conferred by law.
Cannot exceed legislative grant of authority.
Acts in a mostly advisory capacity to the DPR. The following powers and duties are identified in the Act and
regulations:
• Recommend development and selection of licensure examinations to DPR.
• Evaluate the professional and training of reciprocal applicants.
• Conduct disciplinary hearings, and report findings of fact, conclusions of law, and recommendations
regarding discipline to DPR.
• Swear in witnesses at disciplinary hearings.
• Disbursement of funds collected from license renewals, which are set aside within the Illinois State
Pharmacy Disciplinary Fund.
• Make written recommendations to DPR, which are required before the Director may take any action.
• Prepare annual reports of the year’s activities for DPR and public.
• Review ACPE list of accredited pharmacy programs in order to determine whether minimum criteria
are met.
• Make written recommendations to DPR concerning restoration of suspended or revoked licenses.
Powers and Duties

• Executive administrator and chief enforcement officer of the Pharmacy Practice Act.
Inspections, Inspectors and Miscellaneous Prosecution / Discipline Issues
Secretary of DFPR is required to appoint a Chief Pharmacy Coordinator.

Chief Pharmacy Coordinator: Appointment and Qualifications
• Appointed by DFPR Secretary.
• Cannot be a member of the Board.
• Must be a registered pharmacist in good standing, and a graduate of an accredited college of
pharmacy or have BS in Pharmacy.
• At least five (5) years experience in practice of pharmacy immediately prior to his appointment.
74
• The chief pharmacy coordinator shall be the executive administrator and the chief enforcement
officer of this Act.
Pharmacy Investigators
DFPR shall employ as many pharmacy investigators as deemed necessary.
• Note: Used to require at least 4 investigators. That is no longer the case.
• who shall report to the pharmacy coordinator or a deputy pharmacy coordinator.
• Each pharmacy investigator shall be a licensed pharmacist unless employed as a pharmacy
investigator on or before 8/27/15.
Pharmacy investigators shall have the right to enter and inspect, during business hours, any pharmacy or
any other place in this State holding itself out to be a pharmacy where medicines, drugs or drug products, or
proprietary medicines are sold, offered for sale, exposed for sale, or kept for sale.
The Department shall also employ at least one attorney to prosecute violations of this Act and its rules.
Attorney need not be a pharmacist.
Department Attorney - The Department shall also employ at least one attorney to prosecute violations of the
pharmacy law and rules. The attorney need NOT be a pharmacist.
Grounds for Discipline: Lying, Stealing, Cheating, and Illness
The DPR may refuse to issue or renew, or may revoke, suspend, place on probation, fine or take other
disciplinary action with respect to any license or certificate or may impose a fine upon a licensee or registrant
not to exceed $10,000 per violation for any one or combination of the following causes:
• Material misstatement in furnishing information to DPR.
• Violations of Act or regulations. Regulations prohibit violations of Illinois and Federal Food, Drug
and Cosmetics Act, Hypodermic Syringes and Needles Act, Illinois and Federal Controlled Substances
Act, Cannabis Control Act, Illinois and Federal Poison Prevention Packaging Act, and the Wholesale
Drug Distribution Licensing Act. Would also include counseling regulations.
• Misrepresentation for purpose of obtaining license.
• Pattern of misconduct which demonstrates unfitness to practice.
• Assisting or aiding another person in violating Act or regulations.
• Failing to respond to DPR’s written request for information within 60 days.
• Engaging in dishonorable, unethical or unprofessional conduct of a character likely to deceive,
defraud or harm the public. NOTE – See below for additional information about conduct that falls
within the scope of “unprofessional conduct”
• Adverse action taken by another state or jurisdiction against a license or other authorization to
practice as a pharmacy, pharmacist, registered certified pharmacy technician, or registered
pharmacy technician that is the same or substantially equivalent to those set forth in this Section, a
certified copy of the record of the action taken by the other state or jurisdiction being prima facie
evidence thereof.
• Directly or indirectly giving to or receiving from any form of compensation for professional services
not actually or personally rendered.
• Violations of any terms of probation.
• Selling drug samples.
• Physical illness, including deterioration through aging or loss of motor skill which results in inability
to practice with reasonable judgment, skill or safety.
• Applying for or obtaining licensure or registration by fraudulent means.
75
• Conviction by plea of guilty or nolo contendere, finding of guilt, jury verdict, or entry of judgment or
sentencing, including, but not limited to, convictions, preceding sentences of supervision, conditional
discharge, or first offender probation, under the laws of any jurisdiction of the United States that is
(i) a felony or (ii) a misdemeanor, an essential element of which is dishonesty, or that is directly
related to the practice of pharmacy.
• Habitual or excessive use or addiction to alcohol, narcotics, stimulants or other chemical agent which
results in inability to practice with reasonable skill, judgment or safety.
• Willfully making or filing false records or reports in the practice of pharmacy, including Medicaid
fraud.
• Gross and willful overcharging for professional services, including filing false statements for
collections of fees for services not rendered.
• Dispensing prescription drugs without a written or oral prescription.
• Substantial discrepancy in DPR audit of prescription drug inventory, including controlled substances.
• Physical or mental illness or any other impairment or disability, including, without limitation: (A)
deterioration through the aging process or loss of motor skills that which results in the inability to
practice with reasonable judgment, skill or safety; or (B) mental incompetence, as declared by a court
of competent jurisdiction.
• Violation of the Health Care Worker Self-Referral Act.
• Failing to sell or dispense any drug, medicine, or poison in good faith.
• Interfering with the professional judgment of a pharmacist by any registrant under this Act, or his or
her agents or employees.
• Failing to report within 60 days to the Department any adverse final action taken against a pharmacy,
pharmacist, pharmacist technician, or certified pharmacist technician by another licensing
jurisdiction in any other state or any territory of the United States or any foreign jurisdiction, any
governmental agency, any law enforcement agency, or any court for acts or conduct similar to acts or
conduct that would constitute grounds for discipline as defined in this Section.
• Failing to comply with a subpoena.
• Disclosing protected health information in violation of any State or federal law.
• Willfully failing to report an instance of suspected abuse, neglect, financial exploitation, or self-
neglect of an eligible adult as defined in and required by the Adult Protective Services Act.
• Being named as an abuser in a verified report by the Department on Aging under the Adult Protective
Services Act, and upon proof by clear and convincing evidence that the licensee abused, neglected, or
financially exploited an eligible adult as defined in the Adult Protective Services Act.
• Failure to file or pay any tax, penalty or interest, may result in a refusal to issue or suspension of
license or registration until the tax, penalty or interest is paid.
• Second conviction of felony under the Illinois Controlled Substances Act or Second conviction of a
Class 1 felony under Section 8A-3 (illegal kick-backs) or 8A-6 of the Illinois Public Aid Code shall
result in revocation.
• Substantial violations of prohibition against engaging in unauthorized practice, or allowing employee
to engage in unauthorized practice, or of section dealing with record keeping discrepancies (#19
above) may result in a fine not to exceed $2,000.00.
• Violation of CE requirement may result in fine not to exceed $1,000.00.
• Mental illness or disability:
o Immediate suspension without hearing if DPR receives notice from Dept. of Mental Health,
Public Aid or Public Health that continued practice poses immediate danger to public. DPR
must hold hearing within 15 days after suspension under this provision.
o Automatic suspension if licensee is involuntarily committed to mental health facility.
Suspension ends only upon finding by court that licensee is fit to leave facility, and Board
determines that licensee is fit to return to practice.
76
o The entry of an order or judgment by any circuit court establishing that any person holding a
license or certificate under this Act is a person in need of mental treatment operates as a
suspension of that license. A licensee may resume his or her practice only upon the entry of
an order of the Department based upon a finding by the Board that he or she has been
determined to be recovered from mental illness by the court and upon the Board's
recommendation that the licensee be permitted to resume his or her practice.
o In enforcing this Section, the Board or the Department, upon a showing of a possible
violation, may compel any licensee or applicant for licensure under this Act to submit
to a mental or physical examination or both, as required by and at the expense of the
Department.
o The examining physician shall be those specifically designated by the Department. The
Board or the Department may order the examining physician to present testimony
concerning this mental or physical examination of the licensee or applicant. No information
shall be excluded by reason of any common law or statutory privilege relating to
communication between the licensee or applicant and the examining physician. The
individual to be examined may have, at his or her own expense, another physician of his or
her choice present during all aspects of the examination.
o Failure of any individual to submit to a mental or physical examination when directed shall
result in immediate suspension of his or her license until such time as the individual submits
to the examination.
Any pharmacist or pharmacy technician whose license was granted, continued, reinstated, renewed,
disciplined, or supervised, subject to such terms, conditions, or restrictions, and who fails to comply with
such terms, conditions, or restrictions or to complete a required program of care, counseling, or treatment, as
determined by the chief pharmacy coordinator or a deputy pharmacy coordinator, shall be referred to the
Secretary for a determination as to whether the licensee shall have his or her license suspended immediately,
pending a hearing by the Board.
In instances in which the Secretary immediately suspends a license a hearing upon such person's license must
be convened by the Board within 15 days after such suspension and completed without appreciable delay.
The Board shall have the authority to review the subject pharmacist's or pharmacy technician's record of
treatment and counseling regarding the impairment.
Unprofessional/Unethical Conduct
(68 Ill. Adm. Code 1330.30)
Unprofessional and Unethical conduct shall include but not be limited to:
a) Failing to establish and maintain effective controls against diversion of prescription drugs.
b) Committing theft or diversion, or attempting to commit theft or diversion, by a registrant or licensee.
c) Making or filing a report or record that a pharmacist or pharmacy knows to be false or intentionally or
negligently failing to file a report or keep records as required by the Act or this Part.
d) Knowingly dispensing a prescription drug after the death of the person for whom the prescription was
written.
e) Billing or charging for quantities of drugs greater than that which was delivered or charging patients
for a brand drug when a generic is dispensed.
f) Submitting fraudulent billing or reports to a third party payer or claiming a fee for a service that is not
performed or earned.
g) Filling a prescription when a pharmacist knows, or reasonably should know, that no valid physician-
patient relationship exists or failing to exercise sound professional judgment with respect to the accuracy
and authenticity of any prescription/drug order dispensed.
77
h) Failing to provide patient counseling in accordance with this Part, failing to respond to requests for
patient counseling, attempting to circumvent patient counseling requirements, or otherwise discouraging
patients from receiving patient counseling concerning their prescription medications.
i) Discriminating in any manner against a person or group based upon that person or group's religion,
race, creed, color, gender, sexual orientation, age or national origin.
j) Knowingly dispensing a prescription drug without a valid prescription. Dispensing or offering to
dispense any drug not approved by the Food and Drug Administration (FDA), found in the USP-NF, or
found on the list promulgated by the FDA for bulk drug substances that may be used to compound drug
products.
k) Failing to keep one's self and one's apparel clean or to wear identification bearing name and
designation.
l) Directly or indirectly furnishing to a medical practitioner prescription order-blanks that refer to a
specific pharmacist or pharmacy in any manner.
m) Actively or passively participating in any arrangement or agreement in which a prescription order-
blank is prepared, written, or issued in a manner that refers to a specific pharmacist or pharmacy.
Pharmacy-branded enrollment forms, when a patient requests his or her prescriptions be filled at a
specific pharmacy, and Risk Evaluation and Mitigation Strategies documents containing prescription
information are not prohibited by this subsection.
n) Dividing a prescription order unless directed by the prescriber, payer or patient or when the full
quantity of that prescription medication is not available at that location.
o) Committing dispensing errors that result in hospitalization of a patient or demonstrating a pattern and
practice of dispensing errors.
p) Committing an act or acts that are of a flagrant and obvious nature so as to constitute conduct of such a
distasteful nature that accepted codes of behavior or codes of ethics are breached.
q) Committing an act or acts in a relationship with a patient that violate common standards of decency or
propriety.
r) Willfully violating, or knowingly assisting in the violation of, any law relating to the use of habit-
forming controlled substances.
Violations
In addition, the regulations identify additional, specific conduct that constitutes a violation.
A registrant shall not:
• Engage in a professional association, with any place defined as a drug store or pharmacy in the Act,
wherein the practice of pharmacy is engaged in by any person who is not authorized to practice
under the Act or that is not operated and conducted in compliance with the Act.
• Compound, sell or offer for sale, or cause to be compounded, sold or offered for sale, any drug,
medicine, poison, chemical or pharmaceutical preparation, under or by a name recognized in the
United States Pharmacopeia/National Formulary for internal or external use which differs from
standard of strength, quality, purity, or bioavailability as determined by the tests specified in the
United States Pharmacopeia/National Formulary which is official at the time of such compounding,
sale or offering for sale.
• Compound, sell or offer for sale, or willfully cause to be compounded, sold or offered for sale, any
drug, medicine, poison, chemical or pharmaceutical preparation, the strength or purity of which shall
fall below the professed standard of strength or purity under which it is sold.
• Purchase prescription drugs from any source that fails to meet provisions of the Wholesale Drug
Distribution Licensing Act [225 ILCS 120].
• No registrant shall violate any of the following laws, or the rules or regulations promulgated
pursuant to these laws, which relate to the practice of pharmacy:
78
o Illinois Food, Drug and Cosmetic Act [410 ILCS 620].
o Hypodermic Syringes and Needles Act [720 ILCS 635].
o Federal Food, Drug and Cosmetic Act (21 USC 301 et seq.).
o Federal Controlled Substances Act (21 USC 801 et seq.).
o Illinois Controlled Substances Act [720 ILCS 570].
o Cannabis Control Act [720 ILCS 550].
o Illinois Poison Prevention Packaging Act [430 ILCS 40].
o Poison Prevention Packaging Act of 1970 (15 USC 1471 et seq.).
o Wholesale Drug Distribution Licensing Act [225 ILCS 120].
If a licensee or registrant is disciplined in another state he or she must inform the Division within 60
days.
Exam Tip: When presented with a fact pattern, and asked whether the conduct could result in
discipline, err on the side of imposing discipline.
Qualifications for Licensing of Pharmacists, “Interns” and Technicians

Initial Licensure for Pharmacists
Complete and submit an application for licensure to the Board of Pharmacy
Must be a
• US citizen or legally admitted alien
• Graduate of an approved pharmacy school or program
Application fee
Completion of 400 hours of apprenticeship under the direct supervision of an Illinois registered pharmacist;
fulfilled during clinical rotations while enrolled in pharmacy school
Pass State Board Exam
A score of “75” (not percent) on both sections – NAPLEX and MPJE®

• Theoretical and Applied Pharmaceutical Sciences
• Pharmacy Jurisprudence
• Illinois Law
• Federal Law
Applicants failing the Board 3 times must furnish proof of remedial education on the subjects failed on the
third exam.
Registration as a pharmacy technician

Any person shall be entitled to registration as a registered pharmacy technician who:
• is of the age of 16 or over,
• has not engaged in conduct or behavior determined to be grounds for discipline under this Act,
• is attending or has graduated from an accredited high school or comparable school or educational
institution or received a GED, and has filed a written application for registration on a form to be
prescribed and furnished by the Department for that purpose.
79
The Department shall issue a certificate of registration as a registered pharmacy technician to any applicant
who has qualified as aforesaid, and such registration shall be the sole authority required to assist
licensed pharmacists in the practice of pharmacy, under the supervision of a licensed pharmacist.
A registered pharmacy technician may, under the supervision of a pharmacist, assist in the practice of
pharmacy and perform such functions as assisting in the dispensing process, offering counseling, receiving
new verbal prescription orders, and having prescriber contact concerning prescription drug order
clarification. A registered pharmacy technician may not engage in patient counseling, drug regimen
review, or clinical conflict resolution.
No pharmacist whose license has been denied, revoked, suspended, or restricted for disciplinary purposes
may be eligible to be registered as a pharmacy technician.
Even if registered, there are SIX things a technician CANNOT do:

• “Sell” C-Vs (exempt narcotics);
• Dispense in absence of a pharmacist;
o Can remain in pharmacy but cannot practice
• “Transfer” a prescription to another pharmacy;
• Be in pharmacy when C-IIs are not secured (unless RPh is present);
• Counsel patients; and
• A technician is prohibited from participating in drug regimen review, or clinical conflict resolution.
Student Pharmacist
Any person registered as a pharmacy technician who is also enrolled in a first professional degree program in
pharmacy in a school or college of pharmacy or a department of pharmacy of a university approved by the
Department or has graduated from such a program within the last 18 months, shall be considered a "student
pharmacist" and entitled to use the title "student pharmacist". A student pharmacist must meet all of the
requirements for registration as a pharmacy technician set forth in this Section excluding the requirement
of certification prior to the second registration renewal and pay the required pharmacy technician
registration fees. A student pharmacist may, under the supervision of a pharmacist, assist in the practice of
pharmacy and perform any and all functions delegated to him or her by the pharmacist.
Foreign Graduates
Any person seeking licensure as a pharmacist who has graduated from a pharmacy program outside the
United States must register as a pharmacy technician and shall be considered a "student pharmacist" and be
entitled to use the title "student pharmacist" while completing the 1,200 clinical hours of training approved
by the Board of Pharmacy described and for no more than 18 months after completion of these hours. These
individuals are not required to become certified pharmacy technicians while completing their Board
approved clinical training, but must become licensed as a pharmacist or become a certified pharmacy
technician before the second pharmacy technician registration renewal following completion of the Board
approved clinical training.
The Department shall not renew the pharmacy technician license of any person who has been registered as a
"student pharmacist" and has dropped out of or been expelled from an ACPE accredited college of pharmacy,
who has failed to complete his or her 1,200 hours of Board approved clinical training within 24 months or
who has failed the pharmacist licensure examination 3 times and shall require these individuals to meet the
requirements of and become registered a certified pharmacy technician.
Exemption from Registration for Non-Resident Non-Traditional PharmD Students

Any person who is enrolled in a non-traditional Pharm.D. program at an ACPE accredited college of pharmacy
and is a licensed pharmacist under the laws of another United States jurisdiction shall be permitted to engage
in the program of practice experience required in the academic program by virtue of such license. Such
80
person shall be exempt from the requirement of registration as a registered pharmacy technician while
engaged in the program of practice experience required in the academic program.
An applicant for registration as a pharmacy technician may assist a pharmacist in the practice of pharmacy
for a period of up to 60 days prior to the issuance of a certificate of registration if the applicant has
submitted the required fee and an application for registration to the Department. The applicant shall keep a
copy of the submitted application on the premises where the applicant is assisting in the practice of pharmacy.
The Department shall forward confirmation of receipt of the application with start and expiration dates of
practice pending registration. If application is not processed and license is not issued within 60 days, MUST
STOP WORKING AS A TECHNICIAN.
A technician must become CERTIFIED either when the license is issued or on or before the second license
renewal. If the registrant has not yet attained the age of 18, then upon the next renewal as a registered
pharmacy technician, the registrant must meet the requirements for certification and register as a registered
certified pharmacy technician. This requirement does not apply to pharmacy technicians registered prior to
January 1, 2008.
• Student Pharmacists are exempt from the certification requirements.
Certified pharmacy technician
An individual registered as a pharmacy technician under this Act may receive certification as a certified
pharmacy technician, if he or she meets all of the following requirements:
• He or she has submitted a written application in the form and manner prescribed by the Board.
• He or she has attained the age of 18.
• He or she is of good moral character, as determined by the Department.
• He or she has (i) graduated from pharmacy technician training meeting the requirements set forth in
subsection (a) of Section 17.1 of this Act or (ii) obtained documentation from the pharmacist-in-
charge of the pharmacy where the applicant is employed verifying that he or she has successfully
completed a training program and has successfully completed an objective assessment mechanism
prepared in accordance with rules established by the Board.
• He or she has successfully passed an examination accredited by the National Organization of
Certifying Agencies, as approved and required by the Board.
• He or she has paid the required certification fees.
No pharmacist whose license has been denied, revoked, suspended, or restricted for disciplinary purposes
may be eligible to be registered as a certified pharmacy technician.
Continuing Education
As a condition for the renewal of a license as a registered certified pharmacy technician, the registrant shall
provide evidence to the Department of completion of a total of 20 hours of continuing pharmacy education
during the 24 months preceding the expiration date of the certificate. One hour of continuing pharmacy
education must be in the subject of pharmacy law. One hour of continuing pharmacy education must be in
the subject of patient safety. The continuing education shall be approved by the Accreditation Council on
Pharmacy Education.
Technician training
Beginning January 1, 2004, it shall be the joint responsibility of a pharmacy and its pharmacist in charge to
have trained all of its pharmacy technicians or obtain proof of prior training in all of the following topics as
they relate to the practice site:
• The duties and responsibilities of the technicians and pharmacists.
81
• Tasks and technical skills, policies, and procedures.
• Compounding, packaging, labeling, and storage.
• Pharmaceutical and medical terminology.
• Record keeping requirements.
• The ability to perform and apply arithmetic calculations.
o Within 6 months after initial employment or changing the duties and responsibilities of a
pharmacy technician, it shall be the joint responsibility of the pharmacy and the pharmacist
in charge to train the pharmacy technician or obtain proof of prior training in the areas listed
in subsection (a) of this Section as they relate to the practice site.
o All pharmacies shall maintain an up-to-date training program describing the duties and
responsibilities of a pharmacy technician or to document that the pharmacy technician is
making appropriate progress.
o All pharmacies shall create and maintain retrievable records of training or proof of training
as required in this Section.
o
Exam Tip: Illinois does not have a “ratio”, or a limit on the number of technicians that a pharmacist is
permitted to supervise.
License Expiration Dates
Every license issued under the Pharmacy Practice Act, except the certificate of registration as a pharmacy
technician which expires annually, expires on March 31 of each even numbered year.
• Exam Tip: Note also that a pharmacy’s license is deemed to expire 30 days after the PIC ceases to
be PIC, unless a new PIC is named.
• Exam Tip: It is the responsibility of each registrant to notify the Division of any change of address.
Failure to receive a renewal form from the Division shall not constitute an excuse for failure to pay
the renewal fee.
Practicing or operating on a license or certificate that has expired shall be considered unlicensed activity and
shall be grounds for discipline.
Pharmacist Continuing Education Requirements
Thirty (30) hours of ACPE approved CE during each two year licensure period; waived for first renewal after
initial licensure. Illinois does not require hours in any specific subject matter (i.e., no law/ethics requirement,
no HIV requirement, etc. – as is required in many states).
Licensee required to certify completion of CE requirement at time of license renewal; DPR performs spot
checks to monitor compliance.
Upon showing of good cause, DPR, upon recommendation of Board, may waive CE requirement. Good cause
defined as inability to fulfill requirements due to (1) full-time service in armed service; or (2) extreme
hardship, as determined on individual basis by the Board and limited to documented incapacitating illness,
physical inability to travel to sites of approved programs, or other similar extenuating circumstances (e.g.,
illness of family member).
Application for waiver must pre-date renewal date. If interview before Board is desired, applicant must make
request at time he applies for waiver.
Applicant is considered to be in good standing until DPR reaches a decision.
Failure to comply may result in discipline and fine not to exceed $1,000.00.
82
EXAM TIP: Watch out for answers that include requirements for other states; Illinois does NOT require:
• Two hours of law/ethics
• Any number of hours of live CE programs
• HIV education
• Or any other specific requirements
Registration of Pharmacies
Divisions have been eliminated; Equipment, structural requirements, staffing are set by rule.
Pharmacy Requirements
• Licensed pharmacist must be on duty whenever the pharmacy is open to the public.
• License or registration must be conspicuously displayed.
• Must have adequate security, as defined by rule.
The pharmacy is licensed under this Act to conduct the practice of pharmacy in any and all forms from the
physical address of the pharmacy's primary inventory where U.S. mail is delivered. If a facility, company, or
organization operates multiple pharmacies from multiple physical addresses, a separate pharmacy license is
required for each different physical address.
The Department may allow a pharmacy that is not located at the same location as its home pharmacy and at
which pharmacy services are provided during an emergency situation, as defined by rule, to be operated as
an emergency remote pharmacy. An emergency remote pharmacy operating under this subsection (d) shall
operate under the license of the home pharmacy.
Security Requirements
Whenever the pharmacy (prescription area) is not occupied by a registrant, the pharmacy (prescription area)
must be secured and inaccessible to non-licensed persons (employees and public). This may be accomplished
by measures such as walling off, locking doors or electronic security equipment, as approved by the Division.
68 Ill. Adm. Code 1330.600.
• Note – Technicians are considered to be “licensed personnel”, and are permitted in the pharmacy
when the pharmacist is not present.
Schedule II drugs shall be secured in rooms, vaults, safes, cabinets, etc., under lock, whether by key,
combination or electronically.
Schedule II drugs shall not be distributed among regular stock.
Physical requirements
• Notification shall be submitted to the Division that an existing pharmacy prior to remodeling.
• All dispensing and drug storage areas of the pharmacy must be contiguous.
• The pharmacy area and all store rooms shall be well-lighted and properly ventilated.
Refrigerators shall be for the exclusive use of prescription drugs. No personal or food items shall be stored
in the refrigerator. Refrigeration shall be capable of maintaining temperature within a range compatible with
the proper storage of drugs requiring refrigeration or freezing.
The pharmacy area shall not be used for storage of merchandise that interferes with the practice of pharmacy.
Suitable current reference sources either in book or electronic data form (available in the pharmacy or on-
line), which shall include:
• Facts and Comparisons, or other suitable references determined by the Division that are pertinent to
the practice carried on in the licensed pharmacy.
A telephone shall be immediately accessible in the pharmacy area.
83
Pharmacy Self Inspection (68 Ill. Adm. Code 1330.800)
Every licensed pharmacy shall conduct an annual self-inspection using forms provided by the Division. The
annual self-inspection shall be conducted during the same month, annually, as determined by the pharmacy.
Documentation of the self-inspection shall be maintained at the pharmacy for 5 years. The primary objective
of the self-inspection is to create an opportunity for a pharmacy to identify and correct areas of
noncompliance with State and federal law. This includes, but is not limited to, recordkeeping, inventory,
labeling and sanitation requirements.
Pharmacy Computer Regulations

When electronic data processing equipment is employed by a pharmacy, input of drug information shall be
performed by a pharmacist, or by a pharmacy technician or a certified pharmacy technician under the
supervision of a pharmacist. When orders are entered by pharmacy technicians or certified pharmacy
technicians, the supervising pharmacist must verify the accuracy of the information entered. The identity of
the supervising pharmacist and the technician shall be maintained in the prescription record.
Electronic data processing equipment or media, when used to store or process prescription information, shall
meet the following requirements:
• Must guarantee the confidentiality of the information contained in the database.
• Must require that the transmission of electronic prescriptions from prescriber to pharmacist not be
compromised by interventions, control or manipulation of the prescription by any other party.
Electronic Equipment Requirements for Remote Pharmacies

Remote pharmacies are pharmacies that share services with home pharmacies in order to provide pharmacy
care. The new regulations require:
• The pharmacy shall have a computer, scanner, fax capability and printer.
• All prescriptions shall be scanned and sequentially numbered, and the prescription labels shall be
produced on site and viewed at the home pharmacy.
• Scanned prescriptions shall be displayable on a computer terminal at both the remote pharmacy and
home pharmacy.
• All patient’s demographic and prescription information shall be viewable at both the remote and
home pharmacy in real time.
• Prescriptions dispensed at the remote pharmacy site must be distinguishable from those dispensed
at the home pharmacy.
• In all cases in which electronic data processing equipment is used, the original prescription (either
hard copy or an exact, unalterable image) shall be retained on file according to law to assure access
to the information contained on the prescription in the event of a computer malfunction.
Sanitary Standards
All pharmacies and equipment in the pharmacy shall be maintained in a clean condition and in good repair.
• All waste material shall be immediately deposited in an appropriate waste receptacle.
• There shall be a sink with hot and cold running water for the purposes of hand washing and drug
dispensing. No sink shall be required for pharmacies that do not maintain drug inventory.
• The pharmacy area shall be dry and free from vermin.
• Food and/or beverages shall only be placed in a designated area away from dispensing activities.
• Personal items shall not be placed in an area where they will interfere with dispensing activities.
Pharmaceutical Compounding Standards (68 Ill. Adm. Code 1330.640)

New compounding regulations came into effect in Illinois in 2018.
84
The minimum standards and technical equipment considered adequate for compounding drugs shall include:
• A storage area separate for materials used in compounding.
• Scales and balances for the compounding done in the pharmacy.
• An area of the pharmacy used for compounding activities.
• A heating apparatus.
• A logbook or record keeping system to track each compounded prescription and the components
used.
• A book or reference containing formulas with directions for compounding. The books and references
may be in electronic format and/or available via the Internet.
• The pharmacy operations manual shall contain the policies and procedures pertinent to the level of
complexity and the size of the compounding operations of the practice at that specific pharmacy.
Electronic versions are acceptable.
• Consumable materials, as appropriate to the pharmacy services provided at that specific pharmacy,
such as filter paper, powder papers, empty capsules, ointment jars, bottles, vials, safety closures,
powder boxes, labels and distilled water.
• The pharmacy may compound drug products to be used by practitioners in their office for
administration to patients. [Note: Under 1330.640 Sterile compounding for office use is prohibited
unless the pharmacy is in full compliance with 21 USC 353b. The pharmacy must be registered as an
outsourcing facility and licensed as a wholesale distributor. Sterile compounded drugs may be delivered to
the prescribing practitioner's office for administration pursuant to a valid patient-specific prescription.]
Sales of compounded drugs to other pharmacies not under common ownership, or to clinics, hospitals or
manufacturers are not allowed, except for sales provided by pharmacies contracted to provide centralized
prescription filling services pursuant to Section 25.5 of the Act, including compounding in anticipation of
receiving a prescription or order based on routine, readily observed dispensing patterns.
Pharmaceutical Compounding Standards (68 Ill. Adm. Code 1330.640)

[This section came into effect in November of 2018 and repealed 68 Ill. Adm. Code 1330.670]
All pharmaceutical compounding standards, both sterile and nonsterile, shall be governed by the USP-NF (USP
41-NF 36), as set forth in the United States Pharmacopoeia (USP), 41st Revision and the National Formulary,
36th Edition, Compounding Compendium, with the exception of USP Chapter <800> as it pertains to the
handling of hazardous drugs in health care settings. Beginning May 1, 2019, all pharmaceutical compounding
standards, both sterile and nonsterile, shall be governed by the USP-NF (USP 42-NF 37), as set forth in the 2019
edition of the USP Compounding Compendium, with the exception of USP Chapter <800> as it pertains to the
handling of hazardous drugs in health care settings.
a) A pharmacy may only dispense compounded drugs pursuant to a valid patient-specific prescription,
except as provided in this Section.
b) "Office use" means the administration of a non-patient specific compounded drug to a patient by a
practitioner in the practitioner's office or by the practitioner in a health care facility or treatment
setting. "Office use" does not include a pharmacy's delivery of a compounded drug to a prescribing
practitioner's office pursuant to a valid patient-specific prescription.
c) Sterile compounding for office use is prohibited unless the pharmacy is in full compliance with 21 USC
353b, including becoming registered as an outsourcing facility and licensed as a wholesale drug
distributor pursuant to the Wholesale Drug Distribution Licensing Act [225 ILCS 120]. However, a
sterile compounded drug may be delivered to the prescribing practitioner's office for administration
pursuant to a valid patient-specific prescription.
d) A pharmacist may dispense and deliver a reasonable quantity of a nonsterile compounded drug to a
practitioner for office use by the practitioner in accordance with this Section, provided:
1) The quantity of compounded drug does not exceed the amount a practitioner anticipates may be used in the
practitioner's office before the expiration of the beyond use date of the drug
2) The quantity of compounded drug is reasonable considering the intended use of the compounded drug and the
nature of the practitioner's practice
3) The quantity of compounded drug for any practitioner, and all practitioners as a whole, is not greater than an
85
amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity,
strength, quality and purity of the compounded drug that are consistent with United States Pharmacopoeia
guidelines;
4) The pharmacy maintains readily retrievable records of all compounded drugs ordered by practitioners for
office use. The records must be maintained for a minimum of 5 years and shall include:
A) The name, address and phone number of the practitioner ordering the compounded drug for office use and
the date of the order;
B) The name, strength, quantity and dosage form of the compounded drug provided, including the number of
containers and quantity in each;
C) The date the drug was compounded;
D) The date the compounded drug was provided to the practitioner; and
E) The lot number and beyond-use date
5) The pharmacy affixes a label to any compounded drug that is provided for office use. The label shall include:
A) The name, address and phone number of the compounding pharmacy;
B) The name, strength and dosage form of the compounded drug and a list of active ingredients and strengths.
If the number of active ingredients would prohibit proper labeling, then the pharmacist shall provide to
the practitioner a complete list of the active ingredients and strengths (including those on the label);
C) The pharmacy's lot number and beyond-use date;
D) The quantity or amount in the container;
E) The appropriate ancillary instructions, such as storage instructions, cautionary statements, or hazardous
drug warning labels when appropriate; and
F) The statement "For Office Use Only – Not for Resale".
e) All pharmacies that compound drugs must maintain, at a minimum, the following standards and
equipment:
1) A separate storage area for materials used in compounding;
2) Scales or measuring devices with sufficient accuracy for the products to be compounded;
3) An area of the pharmacy used exclusively for compounding;
4) A logbook or record keeping system to track each compounded drug, which must include the lot number,
expiration date of components used, and beyond-use date of compounded drug. This applies to each nonsterile
compounded drug and each sterile compounded drug with a beyond-use date greater than 24 hours;
5) The current edition of the USP Compounding Compendium. This publication may be in electronic format
and/or available via the internet;
6) If engaged in veterinary drug compounding, "Plumb's Veterinary Drug Handbook" or any other similar
publication approved by the Division;
7) Consumable materials, as appropriate to the pharmacy services provided at that specific pharmacy, including
but not limited to: filter paper, powder papers, empty capsules, ointment jars, bottles, vials, safety closures,
powder boxes, labels and distilled water;
8) Drug Distribution and Control
A) Patient Profile or Medication Record System. A pharmacy generated patient profile or medication record
system shall be maintained, in addition to the prescription file. The patient profile or medication record
system shall contain, at a minimum:
i) Patient’s name;
ii) Date of birth or age;
iii) Gender;
iv) Compounded sterile drugs dispensed;
v) Date dispensed, if off site;
vi) Date compounded;
vii) Drug content and quantity;
viii) Patient directions, if drug is administered off site;
ix) Other drugs or supplements the patient is receiving, if provided by the patient or his or her agent;
and
x) Known drug sensitivities and allergies to drugs and foods.
B) Labeling. Each compounded drug dispensed to patients shall be labeled with the following
information, using a permanent label:
86
i) Name, address and telephone number of the licensed pharmacy, if not used within the facility;
ii) Date dispensed and identifying number, if used off site;
iii) Patient's name and room number, if applicable;
iv) Name of each drug component, strength, amount and dosage form;
v) Directions for use and/or infusion rate, if used off site;
vi) Prescriber's name, if used off site;
vii) Required controlled substances transfer warnings, when applicable;
viii) Beyond-use date, and time if appropriate;
ix) If used offsite, identity of compounding and dispensing pharmacist or other authorized individual;
and
x) Auxiliary label with storage requirements, if applicable.
C) In addition to labeling requirements on the Pharmacy Practice Act [225 ILCS 85] and this Part,
compounded drugs dispensed to patients shall have on the label or an auxiliary label the following: "This
prescription was specifically compounded in our pharmacy for you at the direction of your prescriber."
D) The pharmacist-in-charge shall ensure that records are maintained for 5 years, are readily retrievable and
in a format that provides enforcement agents an accurate and comprehensive method of monitoring
distribution via an audit trail. The records shall include at least the following information:
i) Purchase records; and
ii) Patient profile or medication;
9) Delivery Service. The pharmacist-in-charge shall ensure the environmental control of all preparations
shipped or delivered off site. Therefore, any compounded pharmaceutical must be shipped or delivered to a
patient in temperature controlled (as defined by USP Standards) delivery containers; and
10) Sales of compounded drugs to other pharmacies not under common ownership, or to clinics, hospitals or
manufacturers, other than as provided in subsection (d), are not allowed, except for sales provided by
pharmacies contracted to provide centralized prescription filling services pursuant to Section 25.5 of the Act,
including compounding in anticipation of receiving a prescription or order based on routine, readily observed
dispensing patterns.
f) For sterile compounding, a pharmacy must comply with the following additional requirements:
1) The following current resource materials and texts shall be maintained in the pharmacy and may be in
electronic format:
A) Copies of the Act and this Part, the Illinois Controlled Substances Act [720 ILCS 570] and 77 Ill. Adm. Code
3100, 21 CFR (Food and Drugs), and the Illinois Hypodermic Syringes and Needles Act [720 ILCS 635];
B) One compatibility reference, such as:
i) ASHP's Handbook on Injectable Drugs;
ii) King's Guide to Parenteral Admixtures; or
iii) Any other Division-approved publication; and
C) A file or reference on extended (more than 24 hours) stability data given to finished preparations.
2) Staffing. A pharmacist shall be accessible at all times to enable each licensed facility to respond to patients'
and health professionals' questions and needs. A 24-hour telephone number shall be included on the
prescription label of compounded drugs and medication infusion devices if used off site.
3) Emergency Medications. Pharmacies that dispense compounded sterile drugs to patients in facilities off site
or for administration in the patient's residence shall stock supplies and medications appropriate for
treatment of allergic or other common adverse effects, to be dispensed upon the prescription or order of an
authorized prescriber.
g) Notwithstanding any other provision of this Section, a pharmacy may compound a reasonable quantity
of sterile and nonsterile drug products for office use by a veterinarian.
h) It shall be the ongoing responsibility of the pharmacist-in-charge to ensure that all pharmacists,
student pharmacists, registered certified pharmacy technicians, and registered pharmacy technicians
who participate in compounding activities are adequately trained for the type of compounding in
which they participate. Documentation of this training shall be maintained by the pharmacy at all
times.
i) Any pharmacy that, after initial licensure, chooses to add sterile compounding to the services it
provides must be inspected by, and the compounding area must be approved by, the Department. It
shall be the responsibility of the pharmacist-in-charge to notify the Department and arrange for the
87
inspection.
j) For the purposes of this Section, "off-site" for all pharmacies, other than an onsite institutional
pharmacy, means outside the licensed premises of a pharmacy. "Off-site" for an onsite institutional
pharmacy means outside the institution within which the pharmacy is located.
Application Process
• Complete application on forms provided by DFPR.
• Upon acceptance of application, an inspection of physical requirements is made. Application is
deemed in good order when it is signed, notarized, and the pharmacist-in-charge has been verified to
be in good standing.
• Drug Compliance Coordinator may recommend that pharmacy owner and PIC appear for interview
with the Board.
• For name change or change in PIC, pharmacy owner must complete application on DPR form, pay fee,
and submit present license. If satisfactory, DPR will issue a new license.
• Prior complaints against owner/applicant will delay or prevent licensure:
o DPR may refuse to issue license if owner applying for license owned store which previously
had license revoked, unless rehabilitation shown;
o If complaint filed against store previously owned by applicant owner, DPR may refuse to
issue license, or approve change of ownership, or change of location, until decision rendered;
o If previous pharmacy closes for any reason while a complaint is pending, and owner applies
for license for new pharmacy, DPR shall conduct hearing on previous complaint even if prior
pharmacy is no longer licensed. If prior conduct would result in revocation, new application
will be denied.
o “Owner” means a sole proprietor, partner or shareholder who owns in excess of 5% of
outstanding stock of a corporation, or spouse or child of sole proprietor, partner or
shareholder. This section does not apply to pharmacy owned by corporation which is
publicly traded.
• Pharmacy must open within thirty (30) days of issuance of the pharmacy license.
Change of Ownership of a Pharmacy

A new pharmacy application must be filed whenever:
• 10% or more of the ownership of the business, other than a publicly traded business, to which the
pharmacy licensee was issued is sold or otherwise transferred to a person or entity that does not
hold any interest in the business issued the pharmacy license prior to the sale or transfer; or
• More than half the board of directors or executive officers of a business issued a pharmacy license
change.
Any change of ownership of a parent company that owns a pharmacy shall not be considered a change of
ownership of the pharmacy.
Closing a Pharmacy
Whenever a pharmacy intends to close, the following procedures must be followed:
• Notify the Division in writing 30 days in advance of the closing date.
• Notify customers of the closure at least 15 days in advance of the closing date and where the
customer’s records will be maintained.
• Comply with all DEA requirements for closing a pharmacy.
• On the day the pharmacy closes:
88
o Conduct an inventory of the pharmacy’s controlled substances and maintain the inventory
record for inspection by the Division for 5 years.
o Return the pharmacy license to the Division’s drug compliance investigator or other
authorized Division personnel.
o Notify the Division in writing as to where the controlled substances inventory and records
will be kept and how the controlled substances were transferred or destroyed. Records
involving controlled substances must be kept available for 5 years for inspection by the
Division.
o Notify the Division in writing of the name of the person responsible for and the location
where the closing pharmacy’s prescription files and patient profiles will be maintained.
These records shall be kept for a minimum of 5 years from the date the last original or refill
prescription was dispensed.
• The pharmacy acquiring prescription records from a closing pharmacy must inform the Division
prior to the date when the transaction is going to take place.
• After the closing date, only the pharmacist-in-charge, or other designated pharmacist, of the
pharmacy discontinuing business shall have access to the prescription drugs until those drugs are
transferred to the new owner or other purchaser or are properly destroyed.
• Cover all signage indicating “Drug Store” or “Pharmacy” as soon as practicable. The signage shall be
removed in a timely manner. A sign shall be prominently posted that the pharmacy is closed.
Expiration of Pharmacy License

• Expires on its own on March 31 of even numbered years.
• Automatically expires thirty (30) days after PIC dies, is no longer employed by the pharmacy, or has
license suspended or revoked. (THIS IS A CHANGE IN THE LAW – PREVIOUSLY, IT WAS TEN (10)
DAYS.)
PIC must notify DPR he has ceased being PIC, and owner must notify DPR of identity of new PIC, within 30
days. Failure to do so is grounds for discipline.
No pharmacy may be licensed until a PIC is named, and identity of PIC is indicated on face of pharmacy
license.
Exam Tip: If fact pattern describes a practice that falls within definition of “practice of pharmacy”, the
business location must be licensed as a pharmacy. Also, the individual performing the activity must be a
pharmacist, student pharmacist or technician.
Responsibilities of a PIC
The Pharmacist-In-Charge (“PIC”) (general responsibilities for all pharmacies)

Definition: Pharmacist whose name appears on pharmacy license; and who is responsible for all aspects of
the operation related to pharmacy practice. All pharmacies must have a PIC.
No pharmacy shall be granted a license without a pharmacist being designated on the pharmacy license as
pharmacist-in-charge.
A pharmacy shall have one PIC who shall be routinely and actively involved in the operation of the pharmacy.
A pharmacist may be the PIC for more than one pharmacy however, the PIC must work an average of at least
8 hours per week at each location where he or she is the PIC.
89
If a PIC is on a leave of more than 90 days, a new PIC must be designated.
The responsibilities of the PIC shall include:

• Supervision of all activities of all employees as they relate to the practice of pharmacy;
• Establishment and supervision of the method and manner for storage and safekeeping of
pharmaceuticals, including maintenance of security provisions to be used when the pharmacy is
closed. See, Security Requirements, pg 78).
• Establishment and supervision of the record keeping system for the purchase, sale, delivery,
possession, storage and safekeeping of drugs.
• The development and implementation of a procedure to be utilized in the event of a drug recall that
can be readily activated to assure that all drugs included on the recall are returned to the pharmacy
for proper disposition;
• Establishment of specifications for the procurement of all drugs that will be dispensed by the
pharmacy; and
• Establishment and supervision of a method of documenting an oral prescription from a licensed
physician to a pharmacist and for transmission of that information to the appropriate members of
the nursing staff of the institution or facility.
• The operations of the pharmacy and the establishment and maintenance of security provisions are
the dual responsibility of the pharmacist-in-charge and the owner of the pharmacy.
• Within 30 days after a change of a PIC, the Division shall be notified in writing by the departing PIC.
• In addition to notifying the Division within 30 days, the departing PIC shall, on the effective date of
the change, inventory the following controlled substances:
o All Schedule II drugs, as defined in the Illinois Controlled Substances Act, by actual physical
count; and
o All other scheduled drugs, as defined in the Illinois Controlled Substances Act, by estimated
count.
• The inventory required to be completed when a PIC departs (above) shall constitute, for the purpose
of this Section, the closing inventory of the departing pharmacist-in charge and the initial inventory
of the incoming pharmacist-in-charge. This inventory record shall be preserved in the pharmacy for a
period of 5 years. An affidavit attesting to the completion of the inventory and preservation of the
inventory record, bearing the date of the inventory and the name and signatures of the departing and
the incoming pharmacist-in-charge, shall be submitted to the Division at its principal office within 30
days after the change in the pharmacist-in-charge.
• In the event the departing pharmacist-in-charge refuses to complete the inventory, or that
pharmacist-in-charge is incapacitated or deceased, the initial inventory for the incoming pharmacist-
in-charge shall be the inventory as completed by the incoming pharmacist-in-charge. The incoming
pharmacist-in-charge will not be responsible for any discrepancy that may exist in the inventory
prior to his or her initial inventory.
• When the accuracy, relevance or completeness of any submitted documentation is questioned by the
Division, because of a lack of information, discrepancies or conflicts in information given, or a need
for clarification, the registrant will be required to:
o Provide information as may be necessary; and/or
o Appear for an interview before the Board to explain the relevance or sufficiency, clarify
information given, or clear up any discrepancies or conflict of information.
• Records shall be retained as provided for in Section 18 of the Act. Invoices for all legend drugs shall
be maintained for a period of 5 years either on site or at a central location where records are readily
retrievable. Invoices shall be maintained on site for at least one year from the date of the invoice.
• Whenever a pharmacy intends on changing or adding to the type of pharmacy services it offers, as
listed in Sections 1330.500, 1330.510, 1330.520, 1330.530, 1330.540 and 1330.560, it shall notify
the Division no less than 30 days prior to the change or addition.
90
Duties of PIC When Pharmacy Ceases Operations
• PIC is responsible for proper handling and disposition of all drugs.
• Notify DPR and forward to DPR a copy of the closing inventory of controlled drugs and a statement
concerning intended manner of disposition of all legend drugs and prescription files (within 30
days).
• DPR required to notify PIC of approval, or disapproval along with reasons for disposition, within 30
days of receipt of pharmacist’s statement. If not approved, PIC has 30 days to notify DPR of
alternative procedure.
• If disposition or alternative plan is not completed within 30 days, the DPR may confiscate all legend
drugs. The Notice of Intent to Confiscate shall be considered the final administrative decision of
the DPR for appeal purposes.
• In disposing of controlled substances, compliance with provisions of Illinois Controlled Substances
Act concerning disposition of controlled substances shall be deemed compliance with this section.
NOTE: The thirty (30) day period to make these reports represents a change in the law. Previously, it was 10
days.
TYPES OF PHARMACIES AND SPECIFIC REQUIREMENTS
1. Community Pharmacy Services

Note: Community pharmacies used to be referred to as “Division I pharmacies” under the old Act and rules
Pharmacies that engage in general or specialty community pharmacy practice and are open to, or offer
pharmacy service to, the general public shall, in addition to any other requirements of the Act and this Part,
comply with this Section. A community pharmacy that, in addition to offering pharmacy services to the
general public, provides institutional services shall also comply with Section 1330.520.
Staffing of the Pharmacy – There are no minimum requirements for hour of operation for a community
pharmacy (used to be a minimum of 40 hours per week).
Whenever the hours of the pharmacy differ from those of the establishment in which the pharmacy is located,
the schedule during which pharmacy services are provided shall be conspicuously displayed.
Whenever a pharmacy is open and a pharmacist is not present and available to provide pharmacy services, a
sign stating that situation shall be conspicuously displayed.
No prescription may be “dispensed” when a pharmacist is not physically present in the establishment and on
duty.
Record Keeping Requirements for Dispensing Prescription Drugs

All written RXs and original transcript or copy of verbal prescriptions to be maintained at pharmacy for at
least five (5) years.
For every prescription dispensed, the prescription record shall contain the name, initials or other unique
identifier of the pharmacist who dispenses the prescription drugs. No prescription may be dispensed
after one year from the date of the original issuance of the prescription by the prescriber.
Whenever a prescription is dispensed by a registered pharmacy technician or certified pharmacy

technician under the supervision of a pharmacist, the prescription record shall contain the names, initials
or other unique identifier of both the supervising pharmacist and the registered pharmacy technician
91
or certified pharmacy technician who dispenses the prescription. “Unique identifier” means an electronic
signature, handwritten signature or initials, thumb print, or other acceptable biometric or electronic
identification process.
NOTE: At the time of filling, controlled substance prescriptions must be signed and dated on the face of the
prescription by the pharmacist. Initials or a unique identifier are not sufficient.
Refilling a Prescription
Each refilling of a prescription shall be entered on the prescription or on another appropriate, uniformly
maintained, readily retrievable record that indicates, by the number of the prescription, the following
information:
• The name and dosage form of the drug;
• The date of each refilling;
• The quantity dispensed;
• The name or initials of the pharmacist and the pharmacy technician, if applicable, in each refilling;
and
• The total number of refills for the prescription.
• If the pharmacist doesn't otherwise indicate in a uniformly maintained record, he/she shall be
deemed to have dispensed a refill for the full face amount of the prescription.
Exam Tip: Partial fills are not treated as full refills!
ANOTHER EXAM TIP: A significant change to the Practice Act now permits a pharmacist to exercise
professional judgment, and combine or consolidate refills without calling the doctor in order to provide the
patient with a greater quantity, up to the total number of dosage units authorized on the original RX, plus any
refills.
Example: RX: Digoxin 0.125 mg, qty. 30, SIG: 1 daily. Refills: prn.
The pharmacist is permitted to “combine” or “consolidate” refills, and dispense more than 30 tablets
on a single fill. This would be extremely useful for 3rd party plan prescriptions since the RPh can now
dispense a 90 day supply to maximize benefits, without calling the MD.
Exam Tip: Be careful with controlled substances, mental health drugs, or fact patterns that suggest
there is a risk of an adverse outcome if a larger quantity is dispensed. Although it is still legal to
combine the refills without calling the prescriber, professional judgment would likely dictate that the
pharmacist should call the doctor before doing so.
Non-Controlled substances limited to fifteen (15) months from original issuance date, regardless of number of
refills remaining, or “p.r.n.” instructions.
Note: The Illinois Pharmacy Practice Act states that prescriptions are valid for 15 months after issuance [See:
225 ILCS 85/3(e)]. However, 68 Il. Adm. Code, Section 1330.500(c)(1) states: “No prescription may be
dispensed after one year from the date of the original issuance of the prescription by the prescriber". This
administrative code provision is no longer valid. It has not yet been updated and conflicts with the 15 month
limit set in the Pharmacy Practice Act.
C-III - C-V - limited to five (5) refills in six (6) months.
92
• (720 ILCS 570/312). “A written prescription for Schedule III, IV or V controlled substances shall not
be filled or refilled more than 6 months after the date thereof or refilled more than 5 times unless
renewed, in writing, by the prescriber.”
o Exam Tip: Must still exercise good faith and professional judgment. For example, suppose a
RX is written by a dentist for Tylenol #3 for post tooth extraction dental pain. The dentist
prescribes 20 tablets, to be used 1 or 2 tablets q 4 hours prn post extraction dental pain, with
one refill. The RX is dated 7/1/15, and has one refill indicated. If the patient comes to the
pharmacy on 12/24/15 and seeks a refill for the prescription, can / would you dispense the
refill? MOVE TO CS SECTION
• C-II - Not refillable! Expires 90 days after issuance.
Computerized Recordkeeping
Any information required to be kept pursuant to this Section may be recorded and stored in a computerized
pharmaceutical information system that meets the standards of performance stated in the regulations of the
DEA, and shall include the capability to:
• Retrieve the original prescription order information for those prescription orders currently
authorized for refilling;
• Retrieve the current prescription orders, including, at a minimum, name of drug, date of refill,
quantity dispensed, name and identification code of the manufacturer in the case of a generically
written prescription or a generic interchange, name or initials of the dispensing pharmacist and
technician for each refill, and the total number of refills dispensed to date;
• Supply documentation of refill information entered by the pharmacist using the system through a
hard copy printout of each day's refill data that has been verified for correctness. This printout
must include for each prescription filled at least the following information:
o The name and dosage form of the drug;
o The date of each refilling;
o The quantity dispensed;
o The name or initials of the pharmacist in each refilling and the pharmacy technician, if
applicable;
o The patient's name;
o The prescriber's name; and
o The prescription number for the prescription; or
In lieu of the printout required by subsection (c)(6), the pharmacy shall maintain a bound log book, or
separate file, in which each individual pharmacist involved in the dispensing shall sign a statement
each day, attesting to the fact that the refill information entered into the computer that day has been
reviewed by him/her and is correct as shown. The book or file must be maintained at the pharmacy
employing the system for a period of 5 years after the date of dispensing the appropriately authorized refill.
All refill data shall be maintained by the pharmacy on the premises for 5 years, in accordance with
Section 18 of the Act. The pharmacy shall have the appropriate equipment on the premises to provide readily
retrievable information in the course of an on-site inspection. A hard copy printout shall be provided to the
Division, upon request, within 48 hours.
Illinois also permits pharmacy to make a digital image of the original prescription, and to maintain the digital
image in lieu of the original prescription. Digital imaging system requirements: (1) contain all info required
for manual records; (2) capability to produce hard copy when requested; and (3) system most not allow
image to be altered, revised, or replaced after image is made.
• Prescription “copies” – No legal force or effect; cannot be filled.

o Must stamp: “For Informational Purposes Only”.
93
Prescription Labels
Labels must contain:
• the name and address of the pharmacy wherein the same is sold or dispensed;
• the name or initials of the person, authorized to practice pharmacy under the provisions of this Act,
selling or dispensing the same,
• the date on which such prescription was filled;
• the name of the patient;
• the serial number of such prescription as filed in the prescription files;
• the last name of the practitioner who prescribed such prescriptions;
• the directions for use thereof as contained in such prescription; and
• the proprietary name or names or the established name or names of the drugs, the dosage and
quantity, except as otherwise authorized by regulation of the Department.
Also, federal law requires:

• Federal “Legend” on all Rx medications
o “Caution: Federal law prohibits dispensing without a prescription.”
Controlled substances require “transfer warning”:

• “Federal Law prohibits transfer of this drug to any person other than the patient for whom it was
prescribed.”
Note: Prescriber can no longer request that name of drug be omitted from label.
Exam Tip: Illinois does not require a “beyond-use” date, “discard after”, or expiration date for retail
prescription labels. This is required under the laws of many states.
Transfers
A pharmacist may fill a prescription which is on file at another location provided:
• Patient is advised that prescription on file at other store has been canceled;
• Pharmacist determines that prescription is valid and refillable;
• Transferor pharmacy is notified that the prescription must be canceled;
• Record in writing the prescription order, the name of the transferor pharmacy, prescription number,
drug name and original amount dispensed, date of issuance, and number of refills remaining.
• Consent of prescriber should be obtained if necessary in the professional judgment of the pharmacist.
Interference with professional judgment of pharmacist by other pharmacist, his agents, or employees
shall be grounds for revocation or suspension of pharmacy license.
Procedures for Transferor Pharmacy:
• When satisfied that request is valid and legal, transferor pharmacist shall provide information
accurately and completely;
• shall record on face of RX the name of the transferee pharmacy and pharmacist and date of transfer;
and
• shall cancel RX by writing “VOID” on its face. No further information shall be given or medication
dispensed pursuant to original RX.
• If transferred RX is not picked up by patient, transferee pharmacist shall cancel RX and notify original
pharmacy of same.
94
Transfers from out-of-state pharmacies are permitted, subject to Illinois rules.
C-III through C-V drugs may only be transferred one time. However, per DEA (federal law) and Board
Regulation, a pharmacist who is electronically sharing real-time on line computerized systems may transfer
up to the maximum refills permitted by law and the prescriber’s authorization in accordance with CFR §
1306.26(a).
Exam Tip: There has been a change in the law. The “transfer” of a prescription between pharmacies that
share a common database is no longer considered a transfer. This means: (1) technicians can effectuate
the transaction, and (2) there is no limit on the movement of controlled substance prescriptions.
225 ILCS 85/20 - The dispensing by a pharmacist licensed in this State or another state of a prescription
contained in a common database shall not constitute a transfer, provided that (i) all pharmacies involved in
the transactions pursuant to which the prescription is dispensed and all pharmacists engaging in dispensing
functions are properly licensed, permitted, or registered in this State or another jurisdiction, (ii) a policy and
procedures manual that governs all participating pharmacies and pharmacists is available to the Department
upon request and includes the procedure for maintaining appropriate records for regulatory oversight for
tracking a prescription during each stage of the filling and dispensing process, and (iii) the pharmacists
involved in filling and dispensing the prescription and counseling the patient are identified. A pharmacist
shall be accountable only for the specific tasks performed. Nothing in this Section shall prohibit a pharmacist
who is exercising his or her professional judgment from dispensing additional quantities of medication up to
the total number of dosage units authorized by the prescriber on the original prescription and any refills.
Common Electronic Prescription Files

Same requirements apply, but pharmacies are not required to “physically transfer prescriptions or
information for dispensing purposes.”
DPR and Board “shall not impose greater requirements on either common electronic files or a hard copy
system.”
Computerized systems must satisfy all information requirements of this Section, including invalidation of the
original prescription when transferred between pharmacies accessing the same prescription records or
between pharmacies of the same ownership. If those systems that access the same prescription records have
the capability of cancelling the original prescription, pharmacies using such a system are exempt from the
requirements of this subsection if the transferred prescription can always be tracked to the original
prescription order from the prescribing practitioner and the original prescription can be produced.
When prescription information is transferred to another pharmacy for the purposes of original fill, the
transferring pharmacy must enter a prescription into its system as if that prescription were filled at that
pharmacy.
• Nothing in this Section shall apply to transactions described in Section 20 of the Act.
• A prescription shall only be transferred upon the request or authorization of the person for whom
the prescription was issued, except upon closure of a pharmacy, in which case notice shall be made to
that person, orally or in writing, of the closure and location where the prescription is transferred.
Return and Reuse of Drugs
 Once a dispensed drug is removed from the premises by a patient or the patient’s agent, that drug shall
not be accepted for return or exchange by a pharmacy or pharmacist.
o Does not apply to drugs returned for purposes of destruction. The returned drugs must be
stored separately from the pharmacy's active stock.
95
 Note: remember that controlled substances CANNOT be returned to the pharmacy, even if for purposes
of destruction, except in the event of a recall or a dispensing error!
 Institutional Healthcare Facilities:

 Does not apply to a drug dispensed to a patient of an institutional healthcare facility (even if dispensed by
a retail pharmacy) where a licensed healthcare professional administers the drug and the pharmacist
ensures that:
1) the drugs were stored in compliance with applicable laws;
2) the drugs are not contaminated, deteriorated or beyond their use date;
3) the returns are properly documented; and
4) obtaining payment twice for the same drug is prohibited.
Duty to Dispense Pursuant to a Lawful Prescription
Previously, Illinois had a regulation that required a pharmacy to dispense contraceptive medications. That
regulation has been repealed, in favor of a new regulation that applies to ALL prescription drugs, not just
contraceptive medications.
68 Illinois Administrative Code Section 1330.500 (f) provides that pharmacies have a duty to deliver lawfully
prescribed drugs to patients and to distribute nonprescription drugs approved by the U.S. Food and Drug
Administration for restricted distribution by pharmacies, or to substitute a generic drug as permitted by law
(see section on drug product selection) in a timely manner, or to contact the prescriber to obtain
authorization to dispense a different drug that produces a similar clinical effect in a timely manner, except for
the following or substantially similar circumstances:
(1) When, in the pharmacist's professional judgment, after screening for potential drug therapy
problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions
(including, but not limited to, serious interactions with nonprescription or over-the-counter drugs),
drug-food interactions, incorrect drug dosage or duration of drug treatment, drug-allergy
interactions, or clinical abuse or misuse, pursuant to subsection 3(aa) of the Act, she or he
determines that the drug should not be dispensed due to one of the foregoing clinical reasons;
(2) National or State emergencies or guidelines affecting availability, usage or supplies of drugs;
(3) Lack of specialized equipment or expertise needed to safely produce, store or dispense drugs, such as
certain drug compounding or storage for nuclear medicine;
(4) Potentially fraudulent prescriptions;
(5) Unavailability of drug; or
(6) The drug is not typically carried in similar practice settings in the State.
Other exceptions:
• Pharmacies are NOT required to dispense a drug without payment of their usual and customary or
contracted charge.
• If the lawfully prescribed drug or nonprescription drug approved by the U.S. Food and Drug
Administration for restricted distribution by pharmacies is not in stock or is otherwise
unavailable, or the prescription cannot be filled because of a clinical issue, or because the drug is not
typically carried in that type of pharmacy (i.e., certain specialty drugs), the pharmacy shall provide
the patient or agent a timely alternative for appropriate therapy that, consistent with customary
pharmacy practice, may include obtaining the drug. These alternatives include but are not limited to:
(1) Contact the prescriber to address concerns such as those identified in subsection (e)(1);
(2) If requested by the patient or his or her agent, return unfilled lawful prescriptions to the
patient or agent; or
(3) If requested by the patient or his or her agent, communicate or transmit, as permitted by law,
the original prescription information to a pharmacy of the patient's choice that will fill the
prescription in a timely manner.
96
Violations of this regulation: Engaging in or permitting any of the following shall constitute grounds for
discipline or other enforcement actions:
(1) Intentionally destroying unfilled lawful prescriptions;

(2) Refusing to return unfilled lawful prescriptions;
(3) Violating a patient's privacy;
(4) Discriminating against patients or their agents in a manner prohibited by State or federal laws;
(5) Intimidating or harassing a patient; or
(6) Failing to comply with the requirements of this Section.
2. Offsite Institutional Pharmacy Services (1330.520) - formerly “Division II”

Pharmacies that are not located in the facilities they serve and whose primary purpose is to provide purpose
services to patients or residents of facilities licensed under the Nursing Home Care Act, the Hospital Licensing
Act, or the University of Illinois Hospital Act shall, in addition
Recordkeeping Requirements for Dispensing Prescriptions or Orders
Every prescription or order dispensed shall be documented with the name, initials or other unique identifies
of the pharmacist (and pharmacy technician if one is used)
Each pharmacy must maintain records for 5 years, which shall be readily retrievable and in a format that
provides enforcement agents a concise, accurate and comprehensive method of monitoring drug distribution
via an audit trail. This system may require two or more documents that, when read together, will provide all
required information.
Records must include:

• Name of resident
• Date of order;
• Name, strength and dosage form of drug, or description of the medical device ordered;
• Quantity dispensed (a separate record should be maintained when the quantity billed differs from
the quantity dispensed, e.g., unit dose transfer systems);
• Directions for use;
• Quantity billed;
• Prescriber's name;
• Prescriber's signature and/or DEA number when required for controlled substances; and
• The drug name and identification code or the manufacturer in case of a generically ordered
medication or a generic interchange.
Change of Pharmacy Providers

In the event the long term care facility changes pharmacy provider services, their new provider must obtain
the orders from the long term care facility and verify the authenticity and accuracy of the orders with the
prescriber.
Staffing of the Pharmacy.

When the pharmacy is closed, the public and any employees not registered under the Act are to be prohibited
access to the filling and dispensing area.
97
Labeling Requirements
Medications for Future Use – Parenteral solutions to which drugs or diluents are added
• Name, concentration and volume of the base parenteral solution;
• Name and strength of drugs added;
• Beyond use date and date of admixture. Beyond use date, unless otherwise specified in the individual
compendia monograph shall be not later than the beyond use date on the manufacturer's container
or one year from the date the drug is repackaged, whichever is earlier; and
• Reference code to identify source and lot number of drugs added.
Non-parenterals repackaged for future use

• Brand and/or generic name;
• Strength (if applicable);
• Beyond use date. Unless otherwise specified in the individual monograph, the beyond use date shall
be not later than the beyond use date on the manufacturer's container or one year from the date the
drug is repackaged, whichever is earlier; and
• Reference code to identify source and lot number.
Medications Prepared for Immediate Use

• Name of the resident;
• Resident's room and bed number;
• Dispensing date;
• Quantity dispensed;
• Directions for use;
• Prescriber's name; and
• Beyond use date if less than 60 days from date of dispensing.
Medications dispensed to a specific resident or patient via unit dose

• Name of the resident;
• Resident's room and bed number;
• Date of order;
• Directions for use; and
• Prescriber's name.
3. Onsite Institutional Pharmacy Services – formerly Division III

Pharmacies located in facilities licensed under the Nursing Home Care Act, the Hospital Licensing Act, or the
University of Illinois Hospital Act, or that are operated by the Department of Human Services or the
Department of Corrections, and that provide pharmacy services to residents, patients, employees, prescribers
and students of these facilities, shall, in addition to other requirements of the Act and this Part, comply with
this Section.
Recordkeeping Requirements
98
Every prescription or medication order filled or refilled shall contain the name, initials or other unique
identifier of the pharmacist (and pharmacy technician if one is used) who fills or refills the prescription or
medication order, or the name, initials or other unique identifier may be recorded on another appropriate,
uniformly maintained and readily retrievable record that indicates, at least, the following information:
• The date of filling or refilling; and
• The quantity dispensed.
For all products: Label affixed to the drug container must indicate the initials of the RPh who approves
dispensing. If pharmacy utilizes a drug distribution system which reissues the same label, a separate record
must be maintained which identifies the RPh approving each dispensing.
No prescription may be dispensed for a period in excess of one year from the date of the original issuance of
the prescription by the prescriber.
The PIC shall maintain or have access to the following records for at least 5 years or as otherwise required by
law:
• Records of medication orders and medication administration to patients;
• Procurement records for controlled substances;
• Records of packaging, bulk compounding or manufacturing; and
• Records of actions taken pursuant to drug recalls.
Exam Tip: The following information regarding labeling requirements appears redundant and
unimportant, but may be very important for the MPJE®. Questions regarding labeling do appear on the
exam, and since they are “pharmacy practice” questions, they may be weighted more heavily than other
questions.
All medication repackaged by the pharmacy for future use inside the institution or facility and not intended
for immediate dispensing to a specific patient shall be identified as follows:
• Single dose or multi-dose drugs, except sterile solutions to which a drug has been added, shall be
labeled with:
o Brand and/or generic name;
o Strength (if applicable);
o Beyond use date;
o Reference code to identify source and lot number.
• Sterile solutions to which drugs have been added shall contain on the outer label:
o Name, concentration and volume of the base sterile solution;
o Name and strength of drugs added;
o Beyond use date and time of the admixture;
o Reference code to identify source and lot number of drugs added.
All medication prepared by the pharmacy for immediate dispensing to a specific patient or resident in the
institution or facility shall be identified as follows:
• Single dose or multi-dose drugs, except parenteral solutions to which a drug has been added, shall be
identified with:
o Brand and/or generic name; and
99
o Strength (if applicable).
• Sterile solutions to which drugs have been added shall be identified with:
o Name and strength of drugs added; and
o Beyond use date and time of the admixture.
All medication dispensed to a specific patient in the institution shall be dispensed in a container
identified with the name of the patient and the patient's location. Those institutions or facilities utilizing
a unit-dose and medication cart system may identify the name of the patient and the patient's location on the
outside of the bin of the medication cart, when those carts are filled by the pharmacy.
Labels on all medications dispensed by the pharmacy for immediate dispensing to a patient being
discharged, emergency room patient and/or employee shall contain the following:
• The date filled;
• The quantity dispensed; and
• Directions for use.
NOTE: In another section of the regulations states that drugs dispensed from the ER must meet all labeling
requirements pertaining to Retail pharmacies. Accordingly, If you get a question about an ER patient, apply
the labeling requirements that apply to a Retail pharmacy prescription label. For employees and discharge
patients, use the labeling requirements set forth here.
Investigational new drugs, authorized by the FDA shall be dispensed pursuant to a valid prescription order of
the principal physician-investigator or his authorized clinician. All investigational drugs shall be stored in and
dispensed from the pharmacy and shall be identified with the following information:
• Name of drug and strength (if applicable);
• Beyond use date;
• Reference code to identify source and lot number;
• A label indicating "For Investigational Use Only"; and
• Name and location of the patient. When utilizing a unit-dose and medication cart system, the
pharmacy may identify the name of the patient and the patient's location on the outside of the bin of
the medication cart, when those carts are filled by the pharmacy.
Automated Dispensing and Storage Systems (Pyxis; Omnifell; etc.)

Includes, but is not limited to, mechanical systems that perform operations or activities, other than counting,
compounding, or administration, relative to the storage, packaging or dispensing of medications, and which
collect, control, and maintain all transaction information.
Only persons properly licensed under Illinois laws who have authority to administer medications or persons
working under the direct supervision of those individuals shall have access for removal of prescription
medications for patient use. When the systems are used within a licensed pharmacy, a pharmacist shall be
responsible for dispensing the product. Automated dispensing and storage systems shall not be used for
direct patient access to prescription medications.
Documentation as to type of equipment, serial numbers, content, polices and procedures, and locations shall
be maintained on-site in the pharmacy for review by the DPR. Such documentation shall include, but not be
limited to:
100
• Name and address of the pharmacy or facility where the automated dispensing and storage system is
operational;
• Manufacturer's name and model;
• Quality assurance policy and procedures to determine continued appropriate use and performance of
the automated device; and
• Policies and procedures for system operation, safety, security, accuracy, patient confidentiality,
access, controlled substances, data retention or archival, definitions, downtime procedures,
emergency or first dose procedures, inspection, installation requirements, maintenance, medication
security, quality assurance, medication inventory, staff education and training, system set-up and
malfunction.
Automated dispensing and storage systems shall be used only in settings that ensure medication orders are
reviewed by a pharmacist in accordance with established policies and procedures and good pharmacy
practice.
Automated dispensing and storage systems shall have adequate security systems and procedures, evidenced
by written pharmacy policies and procedures, to:
• Prevent unauthorized access or use;
• Comply with any applicable federal and State regulations; and
• Maintain patient confidentiality.
Records and/or electronic data kept by automated dispensing and storage systems shall meet the following
requirements:
• All events involving access to the contents of the automated dispensing and storage systems must be
recorded electronically;
• Records must be maintained by the pharmacy and must be readily available to the DPR. Such
records shall include:
o identity of system accessed;
o identification of the individual accessing the system;
o type of transaction;
o name, strength, dosage form and quantity of the drug accessed;
o name of the patient for whom the drug was ordered;
o identification of the registrants stocking or restocking and the pharmacist checking for the
accuracy of the medications to be stocked or restocked in the automated dispensing and
storage system; and
o such additional information as the pharmacist-in-charge may deem necessary.
The stocking or restocking of all medications in the automated dispensing and storage systems shall be
accomplished by registrants under the Act.
All containers of medications stored in the automated dispensing and storage systems shall be packaged as a
unit of use for single patient use (e.g., unit dose tab/cap, tube of ointment, inhaler, etc.) and labeled as
specified below:
• SterileSolutions to which a drug or diluent has been added, or which are not in their original
manufacturer's packaging, shall contain the following information on the outer label:
o Name and strength of drugs or diluent added;
o Date and beyond use dateof the admixture. The beyond use date, unless otherwise specified
in the individual compendia monograph, shall be no later than the beyond use date on the
101
manufacturer's container or one year from the date the drug is repackaged; and Reference
code to identify source and lot number of drugs or diluent added.
• Non-parenterals repackaged for future use shall be identified with the following information:
o Trade and/or generic name;
o ii) Strength (if applicable);
o iii) Beyond use date. Unless otherwise specified in the individual monograph, the beyond
use date shall be no later than the beyond use date on the manufacturer's container or one
year from the date the drug is repackaged; and
o iv) Reference code to identify source and lot number.
Exceptions to the "unit of use" requirements in subsections (c)(8)(A) and (B) are as follows:
• Injectable medications stored in their original multi-dose vial (e.g., insulin, heparin) where the
medication may be withdrawn into a syringe or other delivery device for single patient use; or
• Over-the-Counter (OTC) products stored in their original multi-dose container (e.g., antacids,
analgesics) where the medication may be withdrawn and placed into an appropriate container for
single patient use.
• For medication removed from the system for on-site patient administration, the system must
document the following information:
o Name of the patient or resident;
o Patient's or resident's unique and permanent identifier, such as admissions number or
medical records number;
o Date and time medication removed from the system;
o Name, initials, or other unique identifier of the person removing the drug; and
o Name, strength and dosage form of the drug or description of the medical device removed.
The documentation may be on paper, via electronic media or via any other media or
mechanisms as set forth by the Act or this Part or as approved by the DPR.
The automated dispensing and storage systems shall provide a mechanism for securing and accounting for
medications once removed from and subsequently returned to the automated dispensing and storage
systems (e.g., return bin). No medication or device shall be returned directly to the system for immediate
reissue or reuse by a non-registrant under the Act. Medication or devices once removed shall not be reused
or reissued except for:
• Medical devices which can be properly sanitized prior to reuse or reissue; and
• Medication that is dispensed and stored under conditions defined and supervised by the pharmacist
and are unopened in sealed, intact and unaltered containers that meet the standards for light,
moisture and air permeation as defined by the current U.S.P./National Formulary, or by the U.S.P.
Conventions, Inc.
The automated dispensing and storage systems shall provide a mechanism for securing and accounting for
wasted medications or discarded medications.
The quality assurance documentation for the use and performance of the automated dispensing and storage
systems shall include at least the following:
• Safety monitors (e.g., wrong medications removed and administered to patient);
• Accuracy monitors (e.g., filling errors, wrong medications removed); and
• Security monitors (e.g., unauthorized access, system security breaches, controlled substance audits).
Errors in the use or performance of the automated dispensing and storage systems resulting in patient or
resident death shall be reported to the DPR by the pharmacist-in-charge within 30 days after acquiring
knowledge of the incident.
Policy and procedures for the use of the automated dispensing and storage systems shall include a
requirement for pharmacist review of the prescription or medication order prior to the system profiling
102
and/or removal of any medication from the system for immediate patient administration. This does not
apply to the following situations:
• The system is being used as an after hours cabinet for medication dispensing in the absence of a
pharmacist as defined in Section 1330.93(e)(1);
• The system is being used in place of an emergency kit as defined in Section 1330.93(e)(2);
• The system is being used to provide access to medication required to treat the immediate needs of a
patient as defined in Section 1330.93(e)(3). A sufficient quantity to meet the immediate needs of the
patient may be removed until a pharmacist is on duty and available to review the prescription or
medication order. A pharmacist shall check such orders promptly once on duty (e.g., floor stock
system, emergency department, surgery, ambulatory care or same day surgery, observation unit,
etc.).
Policies and procedures for the use of the automated dispensing and storage systems shall include the
following:
• List of medications to be stored in each system;
• List of medications qualifying for emergency or first dose removal without pharmacist prior review
of the prescription or medication order; and
The pharmacist-in-charge shall maintain or have access to all records or documentation specified in this
Section for 5 years or as otherwise required by law.
A copy of all pharmacy policies and procedures related to the use of an automated dispensing and storage
system shall be maintained at all locations where the system is being used.
Duties and Responsibilities of the Pharmacist-in-Charge

The pharmacist-in-charge shall be responsible for:
• Assuring that the automated dispensing and storage system is in good working order and accurately
provides the correct strength, dosage form and quantity of the drug prescribed while maintaining
appropriate recordkeeping and security safeguards;
• Establishment of a quality assurance program prior to implementation of an automated dispensing
and storage system and the supervision of an ongoing quality assurance program that monitors
appropriate use and performance of the automated dispensing and storage system, which is
evidenced by written policies and procedures developed by the pharmacy;
• Providing the DPR with written notice 30 days prior to the installation of or at the time of removal of
an automated storage and dispensing system. Such notice must include, but is not limited to:
o the name and address of the pharmacy;
o the address of the location of the automated dispensing and storage system, if different from
the address of the pharmacy;
o the automated dispensing and storage system's manufacturer and model;
o the pharmacist-in-charge; and
o a written description of how the facility intends to use the automated storage and dispensing
system.
• Determining and monitoring access to and the limits on access (e.g., security levels) to the automated
storage and dispensing system. Such access shall be defined by policies and procedures of the
pharmacy and shall comply with State and federal regulations.
Additional responsibilities of the pharmacist-in-charge or pharmacist designated by the pharmacist-in-charge
shall include:
• Authorizing the assigning of access to, discontinuing access to or changing access to, the system;
• Ensuring that access to the medications complies with State and federal regulations as applicable;
and
103
• Ensuring that the automated dispensing and storage system is stocked/restocked accurately and in
accordance with established, written pharmacy polices and procedures.
Institutional Pharmacies – Dispensing in Absence of a Pharmacist
• After Hour Cabinets

An after-hour cabinet, which is a locked cabinet or other enclosure located outside of the pharmacy area
containing a minimal supply of the most frequently required medication, may be utilized provided that only
personnel specifically authorized by the institution in which the pharmacy is located may obtain access and it
is sufficiently secure to deny access to unauthorized persons. After-hour cabinets shall only be used in the
absence of a pharmacist. When medication is removed from the cabinet or enclosure, written physician's
orders authorizing the removal of the medication shall be placed in the cabinet or enclosure. A log shall be
maintained within the cabinet or enclosure and authorized personnel removing medication shall indicate on
the log the signature of the authorized personnel removing the medication, name of the medication removed,
the strength (if applicable), the quantity removed and the time of removal.
EXAM TIP: After hour cabinets are not the same as Automated Dispensing Units, which can be accessed when
the pharmacy is open.
An automated dispensing and storage system may be used as an after hours cabinet.
• Emergency Kits
Kits containing those drugs which may be required to meet the immediate therapeutic needs of the patient,
and which are not available from any other source in sufficient time to prevent risk of harm to patients by
delay resulting from obtaining the drugs from the other source, may be utilized.
Emergency kits shall be supplied and maintained under the supervision of a pharmacist. Drugs shall be
removed from emergency kits only by authorized pharmacy personnel, persons authorized to administer
medication pursuant to a valid physician's order or a physician licensed to practice medicine in all of its
branches in Illinois.
Emergency kits shall be sealed in some manner which will indicate when the kit has been opened. A label
shall be affixed to the outside of the emergency kit indicating the beyond use date of the emergency kit. The
beyond use date of the emergency kit shall be the earliest expiration date of any drug contained in the kit.
After an emergency kit has been used or upon discovery that the seal has been broken or upon the occurrence
of the beyond use date, the kit shall be returned to the pharmacy to be checked and/or restocked by the last
authorized user. If the pharmacy is closed at such time, the kit shall be returned when it opens.
An automated dispensing and storage system may be used as an emergency kit.
Access to Medication in the absense of night cabinets or emergency kits
Whenever any drug is not available from night cabinets or emergency kits, and the drug is required to treat
the immediate needs of a patient, the drug may be obtained from the pharmacy in sufficient quantity to meet
the immediate need by a nurse authorized by the PIC.
When medication is removed from the pharmacy by an authorized nurse, a copy of the physician's order
authorizing the removal of said medication shall be conspicuously placed in the pharmacy with the container
from which the drug was removed so that it will be found by a pharmacist and checked promptly.
A form shall be available in the pharmacy upon which shall be recorded the signature of the authorized nurse
who removed the medication, the name, strength (if applicable) and quantity of medication removed.
• Dispensing from the ER
104
Drugs may be dispensed from the emergency room only by a practitioner licensed to prescribe and dispense,
only to patients treated in the institution and only during hours in which outpatient institutional pharmacy
services are not available.
Dispensed should be limited to no more than a 72 hour supply, except:
• antimicrobials;
• unit of use packages (inhalers, ophthalmics, otics, etc.);
• drugs dispensed via a Remote Automated Pharmacy System.
Drugs dispensed from the ER must meet all labeling requirements applicable to community pharmacies
4. Nuclear Pharmacy Services
Pharmacies that provide and/or offer for sale radiopharmaceuticals shall, in addition to any other
requirements of the Act and this Part, comply with this Section.
Prior to issuance of a pharmacy license to practice as a nuclear pharmacy:

• The pharmacy shall provide a copy of its Illinois Radioactive Material License issued by the Illinois
Emergency Management Agency in accordance with the Radiation Protection Act.
• The Division shall conduct an on-site inspection of the facility.
The pharmacy shall have:

• Space commensurate with the scope of services provided, but at least 300 square feet; and
• A radioactive storage and product decay facility separate from and exclusive of the "hot" laboratory,
compounding, dispensing, quality assurance and office areas.
Each nuclear pharmacy shall have the following equipment:

• Laminar flow hood;
• Fume hood – minimum of 30 inches in height, which shall be vented through a filter with a direct
outlet to the outside;
• Dose calibrator;
• Refrigerator;
• Class A prescription balance or a balance of greater sensitivity;
• Single-channel or multi-channel gamma scintillation counter;
• Microscope;
• Low level, thin-window portable radiation survey meter;
• Drawing station – lead glass and lead lined;
• Syringe shields; and
• Energy Compensated Geiger Mueller (GM) Probe or ion chamber.
Each nuclear pharmacy shall have the following reference texts available:
• The current edition or revision of the United States Pharmacopoeia – Dispensing Information;
• The current edition or revision of the United States Pharmacopoeia/National Formulary;
• State and federal regulations governing the use of applicable radioactive material; and
• U.S. Public Health Service Radiological Health Handbook.
In addition to the labeling requirements of pharmaceuticals, as stipulated in the Act, the immediate outer
container of a radioactive drug, diagnostic agent or device to be dispensed shall also be labeled to include:
105
• The standard radiation symbol;
• The words "Caution-Radioactive Material";
• The name of the radionuclide;
• The name of the chemical form;
• The amount of radioactive material contained, in milliCuries or microCuries, in the container
contents at the time of calibration;
• If the container contents are in liquid form, the volume in milliliters;
• The requested calibration time for the amount of radioactivity contained;
• The prescription number; and
• The name or initials of the nuclear pharmacist filling the prescription.
The immediate container shall be labeled with:

• The standard radiation symbol;
• The words "Caution-Radioactive Material";
• The name and address of the pharmacy;
• The prescription number;
• Name of radionuclide; and
• Name of chemical form.
Nuclear Pharmacist Requirements. A nuclear pharmacist who serves as the PIC of a nuclear pharmacy and all
other pharmacists employed in the pharmacy shall provide evidence to the Division of the following:
• Licensure as a pharmacist in the State of Illinois; and
• That he/she is named as an authorized user, or works under the supervision of a pharmacist who is
named as an authorized user, on a commercial nuclear pharmacy license issued by the Illinois
Emergency Management Agency(IEMA) or, when a nuclear pharmacist who works under a broad
medical license at a university or research hospital has been approved as a user by that institution's
radiation safety committee in accordance with conditions of the license issued by the IEMA.
5. Telepharmacy
"Telepharmacy" means the provision of pharmacist care by a pharmacist that is accomplished through the
use of telecommunications or other technologies to patients or their agents who are at a distance and are
located within the United States, and which follows all federal and State laws, rules, and regulations with
regard to privacy and security.
Any pharmacy engaged in the practice of telepharmacy must meet all of the following conditions:
• All events involving the contents of an automated pharmacy system must be stored in a secure
location and may be recorded electronically.
• An automated pharmacy or prescription dispensing machine system may be used in conjunction with
the pharmacy's practice of telepharmacy after inspection and approval by the Department.
The pharmacist in charge shall:

• be responsible for the practice of telepharmacy performed at a remote pharmacy, including the
supervision of any prescription dispensing machine or automated medication system;
• ensure that the home pharmacy has sufficient pharmacists on duty for the safe operation and
supervision of all remote pharmacies;
• ensure, through the use of a video and auditory communication system, that a certified pharmacy
technician at the remote pharmacy has accurately and correctly prepared any prescription for
dispensing according to the prescription;
• be responsible for the supervision and training of certified pharmacy technicians at remote
pharmacies who shall be subject to all rules and regulations; and
106
• ensure that patient counseling at the remote pharmacy is performed by a pharmacist or pharmacist
intern
The new rules identifies three types of telepharmacy practice: Remote Dispensing Sites; Remote Consultation
Sites, and Remote Automated Pharmacy Sites. Note that each site where such operations occur shall be a
separately licensed pharmacy.
Remote Dispensing Sites

• These are pharmacy locations where an inventory of drugs are maintained, but they are staffed not
by pharmacists, but by certified pharmacy technicians.
• Prescriptions can be filled by pharmacy techs with at least one year experience, and who are also
certified. The RPh at the “home” pharmacy has an audio and video connection to the pharmacy, and
is required to verify the prescription, and the product placed into the prescription vial, prior to
dispensing.
• Counseling must be done by a pharmacist (not just an) via video link and audio link before the
medication is released to a patient. The pharmacist must counsel the patient or the patient’s agent
on all new prescriptions and refills.
• The facility must have a sign clearly identifying it as a remote dispensing site.
Remote Consultation Site

• These sites have no prescription inventory, and are staffed by technicians or pharmacy technicians.
• Only filled prescriptions, filled at the home pharmacy, with final patient labeling attached are
allowed at these sites. The home pharmacy fills the RX, and delivers it to the Remote Consultation
Site, where the drug is stored and later given to the patient.
• A computer audio/video link for dispensing and consultation to occur.
• The facility shall have a room for patient consultation exclusive of any waiting area.
• The facility must have a sign clearly identifying it as a remote consultation site.
Remote Automated Pharmacy Systems (RAPS)

• These are automated dispensing devices that will dispense prescription drugs directly to a patient.
• These sites have prescription inventory, which must be secured in an automated dispensing device
connected to the home pharmacy.
• A pharmacist, or prescriber when the RAPS is located on the same premises as the prescriber, must
approve all the prescription orders before they are released from the automated dispensing device.
• Dispensing and counseling are performed by a pharmacist employed by the home pharmacy via
audio link and video link or by the prescriber when the RAPS is located on the same premises as the
prescriber.
• All filled prescription must have a label that meets the requirements of the Act attached to the final
drug container.
• The pharmacist-in-charge of the home pharmacy, or a designated registrant, shall conduct and
complete monthly inspections of the remote telepharmacy dispensing machine site. Inspection
criteria must be included in the policies and procedures for the site. The report must be available to
the pharmacy investigators when requested.
• The RAPS must be licensed with the Division and will be subject to random inspection by pharmacy
investigators. For purposes of random inspections, a pharmacist with access to the system must be
available at the site within one hour.
OTHER LAWS AND REGULATIONS RELATING TO “TELEPHARMACY”:
Sec. 22b. Automated pharmacy systems; remote dispensing.
107
• Automated pharmacy systems must have adequate security and procedures to comply with
federal and State laws and regulations and maintain patient confidentiality, as defined by rule.
• Access to and dispensing from an automated pharmacy system shall be limited to pharmacists or
personnel who are designated in writing by the pharmacist-in-charge and have completed
documented training concerning their duties associated with the automated pharmacy system.
• All drugs stored in relation to an automated pharmacy system must be stored in compliance with
this Act and the rules adopted under this Act, including the requirements for temperature,
proper storage containers, handling of outdated drugs, prescription dispensing, and delivery.
• An automated pharmacy system operated from a remote site shall be under the continuous
supervision of a home pharmacy pharmacist. To qualify as continuous supervision, the
pharmacist is not required to be physically present at the site of the automated pharmacy system
if the system is supervised electronically by a pharmacist, as defined by rule.
• Drugs may only be dispensed at a remote site through an automated pharmacy system after
receipt of an original prescription drug order by a pharmacist at the home pharmacy. A
pharmacist at the home pharmacy must control all operations of the automated pharmacy
system and approve the release of the initial dose of a prescription drug order. Refills from an
approved prescription drug order may be removed from the automated medication system after
this initial approval. Any change made in the prescription drug order shall require a new
approval by a pharmacist to release the drug.
• If an automated pharmacy system uses removable cartridges or containers to store a drug, the
stocking or restocking of the cartridges or containers may occur at a licensed wholesale drug
distributor and be sent to the home pharmacy to be loaded after pharmacist verification by
personnel designated by the pharmacist, provided that the individual cartridge or container is
transported to the home pharmacy in a secure, tamper evident container. An automated
pharmacy system must use a bar code verification or weight verification or electronic
verification or similar process to ensure that the cartridge or container is accurately loaded into
the automated pharmacy system. The pharmacist verifying the filling and labeling shall be
responsible for ensuring that the cartridge or container is stocked or restocked correctly by
personnel designated to load the cartridges or containers. An automated pharmacy system must
use a bar code verification, electronic, or similar process, as defined by rule, to ensure that the
proper medication is dispensed from the automated system. A record of each transaction with
the automated pharmacy system must be maintained for 5 years. A prescription dispensed from
an automated pharmacy system shall be deemed to have been approved by the pharmacist. No
automated pharmacy system shall be operated prior to inspection and approval by the
Department.
Sec. 25.5. Centralized prescription filling.

• "Centralized prescription filling" means the filling of a prescription by one pharmacy upon
request by another pharmacy to fill or refill the prescription.
• "Centralized prescription filling" includes the performance by one pharmacy for another
pharmacy of other pharmacy duties such as drug utilization review, therapeutic drug utilization
review, claims adjudication, and the obtaining of refill authorizations.
• A pharmacy licensed under this Act may perform centralized prescription filling for another
pharmacy, provided that both pharmacies have the same owner or have a written contract
specifying (i) the services to be provided by each pharmacy, (ii) the responsibilities of each
pharmacy, and (iii) the manner in which the pharmacies shall comply with federal and State laws,
rules, and regulations.
Sec. 25.10. Remote prescription processing.
108
"Remote prescription processing" means and includes the outsourcing of certain prescription functions to
another pharmacy or licensed non-resident pharmacy, including the dispensing of drugs. "Remote
prescription processing" includes any of the following activities related to the dispensing process:
• Receiving, interpreting, evaluating, or clarifying prescriptions.
• Entering prescription and patient data into a data processing system.
• Transferring prescription information.
• Performing a drug regimen review.
• Obtaining refill or substitution authorizations or otherwise communicating with the prescriber
concerning a patient's prescription.
• Evaluating clinical data for prior authorization for dispensing.
• Discussing therapeutic interventions with prescribers.
• Providing drug information or counseling concerning a patient's prescription to the patient or
patient's agent, as defined in this Act.
A pharmacy may engage in remote prescription processing under the following conditions:
• The pharmacies shall either have the same owner or have a written contract describing the scope of
services to be provided and the responsibilities and accountabilities of each pharmacy in compliance
with all federal and State laws and regulations related to the practice of pharmacy.
• The pharmacies shall share a common electronic file or have technology that allows sufficient
information necessary to process a non-dispensing function.
• The records may be maintained separately by each pharmacy or in common electronic file shared by
both pharmacies, provided that the system can produce a record at either location showing each
processing task, the identity of the person performing each task, and the location where each task
was performed.
Nothing in this Section shall prohibit an individual employee licensed as a pharmacist from accessing the
employer pharmacy's database from a pharmacist's home or other remote location or home verification for
the purpose of performing certain prescription processing functions, provided that the pharmacy establishes
controls to protect the privacy and security of confidential records.
Remote Prescription/Medication Order Processing (68 IL ADC 1330.560)
Any pharmacy may provide remote prescription/medication order processing services to any other
pharmacy as provided in Section 25.10 of the Act and the following further requirements:
• Any nonresident pharmacy shall be registered in its resident state.
• There shall be a secure, HIPAA compliant, electronic communication system that shall include but not
be limited to computer, telephone and facsimile connections.
• The communication system shall give remote access to all relevant patient information to allow the
pharmacist of the remote pharmacy to perform remote medication order processing that shall
include all laboratory results and every patient's or resident's medication profile, if appropriate.
• The secure electronic communication system shall be maintained on a daily basis. If this system
malfunctions, the remote processing pharmacy shall cease operations related to the institution
affected.
Record Keeping Requirements

A policy and procedure manual shall be maintained by the remote prescription/ medication order processing
pharmacy pertaining to the pharmacy's operations. The manual shall:
• Be accessible to the remote prescription/medication order processing pharmacy staff and the staff at
the dispensing pharmacy;
• Be available for inspection by the Division;
109
• Outline the responsibilities of the remote prescription/medication order processing pharmacy staff
and the staff at the dispensing pharmacy;
• Include a current list of the name, address, telephone number and license number of each pharmacist
involved in remote prescription/medication order processing;
• Include policies and procedures for:
o Protecting the confidentiality and integrity of patient information;
o Ensuring that pharmacists performing remote prescription /medication order processing have
access to appropriate drug information resources;
o Ensuring that medical and nursing staff when appropriate, understand how to contact a
pharmacist;
o Maintaining records to identify the name, initials, or identification code of each pharmacist who
performs any processing function;
o Complying with federal and State laws and regulations;
o Operating or participating in a continuous quality improvement program for pharmacy services
designed to objectively and systematically monitor and evaluate the quality and appropriateness
of patient care, pursue opportunities to improve patient care, and resolve identified problems;
o Reviewing the written policies and procedures and documenting the review annually.
Every pharmacist providing remote prescription/medication order processing services shall record on the
order, in the computer system, or on another appropriate, unalterable, uniformly maintained and readily
retrievable record the following information for every medication order or prescription processed on behalf
of a dispensing pharmacy:
• The name, initials or other unique identifier of the pharmacist who verifies the medication order or
prescription;
• The name of the patient or resident;
• The name, dose, dosage form, route of administration and dosing frequency of the drug;
• The date and time of verification;
• The name of the prescribing/ordering practitioner;
• Any other information that is required by the dispensing pharmacy being served for use in its own
records.
The records for medications entered at the remote prescription/medication order processing pharmacy must
be distinguishable and readily retrievable from those entered at the institution being served.
The pharmacist-in-charge of the remote prescription /medication order processing pharmacy shall maintain
and have access to the following records for a minimum of 5 years:
• Records of medication orders processed;
• Records of the electronic communication system maintenance.
The remote prescription/medication order processing pharmacy shall maintain a record containing the
names and license numbers of all pharmacies to which they are providing services and the number of hours
per day the services are being provided.
In a non-retail setting, all pharmacists practicing at a remote pharmacy shall be licensed in Illinois. However,
when pharmacists are providing remote prescription/medication order processing for a community
pharmacy licensed in Illinois from a community pharmacy licensed in Illinois but located out-of-state, only
the PIC of the remote pharmacy must be licensed in Illinois.
Only licensed pharmacists at the pharmacy providing remote pharmacy services shall conduct the drug
utilization evaluation or review and validation of any order processed within the remote pharmacy.
6. Non-Resident Pharmacies
110
A pharmacy that is physically located outside the state, but which delivers drugs to patients located in the
state.
Registration required; to register, non-resident pharmacy must certify:

• It is licensed in the state where the dispensing facility is located and from which drugs are dispensed;
• The location, names and titles of all principal corporate officers and all pharmacists who are
dispensing drugs to residents of this State;
• That it complies with all lawful directions and requests for information from the board of pharmacy
of each state in which it is licensed or registered, except that it shall respond directly to all
communications from the Board concerning emergency circumstances arising from the dispensing of
drugs to residents of this State.
• That it maintains its records of drugs dispensed to residents of this State so that the records are
readily retrievable from the records of other drugs dispensed;
• That it cooperates with the Board in providing information to the board of pharmacy of the state in
which it is licensed concerning matters related to the dispensing of drugs to residents of this State;
and
• That during its regular hours of operation, but not less than 6 days per week, for a minimum of 40
hours per week, a toll free telephone service is provided to facilitate communication between
patients in this State and a pharmacist at the pharmacy who has access to the patients' records. The
toll free number must be disclosed on the label affixed to each container of drugs dispensed to
residents of this State.
To obtain nonresident special pharmacy registration in Illinois, an applicant shall file an application with the
Division, on forms provided by the Division, that includes:
• Disclosure and certification of information required in subsection (a); and
• The fee required fee by Section 1330.20.
Nonresident special pharmacy registration shall expire on March 31 of each even numbered year and may be
renewed during the 60 days preceding the expiration date by paying the fee required by Section 1330.20.
Drug Product Selection
The interchange for a prescribed pharmaceutical product in accordance with the Act and the Illinois FDCA.
Three things are required to substitute:
• Prescriber must not prohibit;
• Product must be included in the Illinois Formulary (Illinois has a “positive” formulary”);
• Product dispensed must have a lower unit cost that the product prescribed.
Note: When transferring a prescription, pharmacists are to designate the prescriber's original intent
concerning drug product selection on every prescription record transferred to another pharmacy,
irrespective of the method of transfer. The receiving pharmacy shall record the prescriber's drug product
selection intent on the original prescription record of the transferred prescription. 77 IL ADC 790.320.
NOTE: Patient consent is no longer required!
Documentation
Pharmacist must indicate on prescription the name or other identification of the manufacturer of the
dispensed product.
Immunity from Civil Liability

Selection of product shall not constitute evidence of negligence if:
111
• For legend products, it is listed in formulary;
• For non-legend product, product was in same dosage form and active ingredients did not vary by
more than 1%
• Physician’s failure to prohibit DPS does not constitute evidence of negligence unless prescriber has
reasonable cause to believe that patient’s health condition warrants use of brand name.
Criteria for Formulary Inclusion

• Orange Book or Dept. of Public Health “Notification List.”
• All products must have an approved NDA or ANDA;
• All products must be manufactured under cGMPs.
• All products must meet FDA bioequivalent requirements.
• Products found to be ineffective in FDA’s DESI review, but not yet removed from market, are
excluded.
Orange Book
All FDA-approved drug products are listed and rated for bioequivalency to the innovator product
Therapeutic equivalence codes – first letter (“prefix”) refers to equivalency rating

• “A” = Substitutable
• “B” = Inequivalent, NOT Substitutable
• Second letter refers to dosage form
o AB – Equivalent solid dosage form; BB not equivalent and not substitutable
o AN - Equivalent solutions and powders for aerosolization ; BN – not equivalent
o AO - Equivalent injectable oil solutions ; BO – not equivalent
o AP - Equivalent injectable aqueous solutions and, in certain instances, intravenous non-
aqueous solutions; BP – not equivalent
o AT - Equivalent topical products; BT – not equivalent
FDA now requires a demonstration of bioequivalence before an ANDA can be approved. Products found not
to be bioequivalent are no longer being approved.
DESI Drugs: Those still appearing in the Orange Book are about 3%—FDA does not have data demonstrating
equivalence or inequivalence.
There is a special rule governing substitution of “anti-epileptic” drugs:
• 225 ILCS 85/26 – Anti-epileptic drug product selection prohibited. (a) The General Assembly
finds that this Section is necessary for the immediate preservation of the public peace, health, and
safety.
• (b) In this Section: "Anti-epileptic drug means (i) any drug prescribed for the treatment of epilepsy
or (ii) a drug used to treat or prevent seizures. "Epilepsy" means a neurological condition
characterized by recurrent seizures. "Seizure" means a brief disturbance in the electrical activity of
the brain.
• (c) When the prescribing physician has indicated on the original prescription "may not substitute", a
pharmacist may not interchange an anti epileptic drug or formulation of an anti epileptic drug for the
treatment of epilepsy without notification and the documented consent of the prescribing physician
and the patient or the patient's parent, legal guardian, or spouse. This Section does not apply to
medication orders issued for anti epileptic drugs for any in patient care in a licensed hospital.
112
The gist is that for all other drugs, the doctor can prohibit substitution only by checking the "MNS" box. For
anti-epileptics, however, the doctor can check the box or write "MNS" on the RX to prohibit substitution.
Interchange of Biologics (“Biosimilars”)

Biologic Products – Means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or
derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product,
or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound),
applicable to the prevention, treatment, or cure of a disease or condition of human beings. These have a large,
complex molecular structure, and are difficult to produce or replicate.
“Interchangeable biological product" means a biological product that the United States Food and Drug
Administration: (1) has (A) licensed and (B) determined it to meet the standards for interchangeability
pursuant to 42 U.S.C. 262(k)(4); or (2) has determined is therapeutically equivalent as set forth in the latest
edition of or supplement to the United States Food and Drug Administration's Approved Drug Products with
Therapeutic Equivalence Evaluations (Orange Book 6).
A pharmacist may substitute an interchangeable biological product for a prescribed biological product only if
all of the following conditions in this subsection (b) are met:
(1) the substituted product has been determined by the United States Food and Drug Administration to
be interchangeable, as defined in subsection (a) of this Section, with the prescribed biological product;
(2) the prescribing physician does not designate orally, in writing, or electronically that substitution is
prohibited in a manner consistent with Section 25 of this Act; and
(3) the pharmacy informs the patient of the substitution.
Within 5 business days following the dispensing of a biological product, the dispensing pharmacist or the
pharmacist's designee shall make an entry of the specific product provided to the patient, including the name
of the product and the manufacturer. The communication shall be conveyed by making an entry that can be
electronically accessed by the prescriber through:
(1) an interoperable electronic medical records system;
(2) an electronic prescribing technology;
(3) a pharmacy benefit management system; or
(4) a pharmacy record.
Entry into an electronic records system is presumed to satisfy the notice requirement. Otherwise, the
pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone,
electronic transmission, or other prevailing means, except that communication shall not be required where:
(A) there is no FDA-approved interchangeable biological product for the product prescribed; or
(B) a refill prescription is not changed from the product dispensed on the prior filling of the prescription.
The pharmacy shall retain a record of the biological product dispensed for a period of 5 years.
The Department shall maintain a link on its Internet website to the current list of all biological products
determined by the United States Food and Drug Administration to be interchangeable with a specific
biological product.
Out of state prescriptions
6Note that the Orange Book does not list biologic products. Those products are listed in the “Purple Book”.
This is an error in the Illinois law.
113
• Illinois pharmacies are permitted to fill or refill valid prescriptions on file in a licensed pharmacy in
another state; may also fill a valid prescription transmitted by an out of state prescriber
• When taking a transfer from an out-of-state pharmacy, must advise patient and notify the other
pharmacy that the prescription must be cancelled before it can be filled or refilled
• Determine validity of prescription
• It is in accordance of prescribers intent
• Prescriber
• In all cases pharmacist can exercise professional discretion to fill, or to refuse to fill, a
prescription issued by an out-of-state prescriber.
Prescription pick up and drop off
225 ILCS 85/16b - Prescription pick up and drop off. Nothing contained in this Act shall prohibit a
pharmacist or pharmacy, by means of its employee or by use of a common carrier or the U.S. mail, at the
request of the patient, from picking up prescription orders from the prescriber or delivering prescription
drugs to the patient or the patient's agent at the residence or place of employment of the person for whom
the prescription was issued or at the hospital or medical care facility in which the patient is confined.
Conversely, the patient or patient's agent may drop off prescriptions at a designated area.
Patient Counseling and DUR
OBRA `90 – Federal law enacted in 1990. Applied only to prescriptions paid for in whole or in part by the
federal government. Required all states to pass laws by 1/1/93 to address counseling and DUR. States could
pass laws that went beyond federally paid prescriptions. Up until 2017, Illinois law required only an offer to
counsel on all new and refill prescriptions. In 2017, however, the law changed again.
68 IL ADC 1330.700 - Patient Counseling

a) Upon receipt of a new or refill prescription, a prospective drug regimen review or drug utilization
evaluation shall be performed. Prior to dispensing a prescription to a new patient, a new medication
to an existing patient, or a medication that has had a change in the dose, strength, route of
administration or directions for use, the pharmacist, or a student pharmacist directed and supervised
by the pharmacist, shall provide verbal counseling to the patient or patient’s agent on pertinent
medication information. An offer to counsel shall be made on all other prescriptions. Counseling shall
include, but is not limited to:
1) Name and description of medication;
2) Dosage form and dosage;
3) Route of administration;
4) Duration of therapy;
5) Techniques for self-monitoring;
6) Proper storage;
7) Refill information;
8) Actions to be taken in cases of missed doses;
9) Special directions and precautions for preparation, administration and use;
10) Common severe side effects, adverse effects, or interactions and therapeutic contraindications
that may be encountered, including their avoidance and the action required if they occur.
b) If, in the pharmacist’s professional judgment, oral counseling is not practicable for the patient or
patient’s agent, the pharmacist shall use alternative forms of patient information. When used in place of
oral counseling, alternative forms of patient information shall advise the patient or agent that the
114
pharmacist may be contacted for consultation in person at the pharmacy or by toll-free or collect
telephone service.
c) Every licensed pharmacy directly serving patients at a physical location must conspicuously post a sign
provided by the Division containing a statement that the patient has the right to counseling, the Division’s
consumer hotline number, information on how to file a complaint for failure to counsel, and any other
information the Division deems appropriate. The sign must be printed in color ink or displayed
electronically in color, measure at least 8 ½ x 11 inches in size, and be posted at either a cashier counter
or waiting area clearly visible to patients. Licensed pharmacies that do not maintain a physical location
directly serving patients must include a copy of the sign within any dispensed prescriptions. The sign will
be available to download on the Division’s website. 7
d) The pharmacist is responsible for maintaining patient profiles as defined in Section 3(s) of the Act. A
reasonable effort shall be made to obtain information, including, but not limited to, the following:
1) Name, date of birth (age), gender, address and telephone number;
2) Individual history, when significant, including disease state, known allergies, drug interactions,
and a comprehensive list of medications and relevant devices; and
3) Pharmacist’s comments relevant to the individual’s therapy.
e) Patient identifiable information obtained by the pharmacist or the pharmacist’s designee for the
purpose of patient record maintenance, prospective drug review, drug utilization review and patient
counseling shall be considered protected health information, as defined in Section 3(cc) of the Act. A
pharmacist shall provide counseling related to protected health information in a discreet, supportive and
informative manner.
f) A pharmacist at an on-site or off-site institutional pharmacy shall not be required to provide patient
counseling as required in this Section unless drugs are dispensed by the pharmacy upon a patient’s
discharge from the institution.
g) Nothing in this Section shall be construed as requiring a pharmacist to provide counseling when a
patient or patient’s agent refuses such counseling. When a patient or patient’s agent refuses to accept
patient counseling as provided in this Section, that refusal shall be documented.
h) A pharmacist operating a remote pharmacy shall comply with the requirements of this Section.
Counseling in those circumstances shall be done by both video and audio means.
Electronic Transmission of Prescriptions
Electronic transmission of prescriptions shall be allowed, provided the following conditions are met:
• The prescription shall be transmitted directly, or through an intermediary, from the authorized
licensed prescriber to the pharmacy of the patient’s choice. No intermediary shall alter the
prescription information or content of the prescription.
• The prescriptions shall comply with all applicable statutes and rules regarding the form, content,
record keeping and processing of a prescription drug.
• The electronically transmitted prescription shall include the following:
o The transmitting prescriber’s facsimile number, if applicable;
o The time and date of the transmission;
o The identity of the person sending the prescription;
o The address and contact information of the person transmitting the prescription.
• The electronic device in the pharmacy that receives the electronically transmitted prescription shall
be located within the pharmacy area.
• A facsimile of an electronically transmitted prescription shall be non-fading and remain legible.
7 Here is a link to the required sign: https://idfpr.com/forms/DPR/PharmPatientEducationSign082017.pdf
115
• The facsimile of the electronically transmitted prescription shall be stored in the pharmacy as
required by State and federal laws or rules and may serve as the record of the prescription.
• The electronically transmitted prescription shall serve as the record of the prescription so long as the
electronically submitted prescription can be stored and is readily retrievable so as to comply with
federal and State record keeping requirements.
• To maintain confidentiality, adequate security and systems safeguards designed to prevent and
detect unauthorized access, modification or manipulation of electronically transmitted prescriptions
is required.
• A pharmacy or pharmacist shall not enter into an agreement with a practitioner or healthcare facility
concerning the provision of any means for the electronic transmission of prescriptions that would
adversely affect a patient’s freedom to select the pharmacy or pharmacy department of his or her
choice.
• Electronically transmitted prescriptions for controlled substances may be dispensed only as
provided by federal law. (720 ILCS 570/311.5 - A Prescriber who is authorized to prescribe
controlled substances in Illinois may issue an electronic prescription for C-II,III,IV or V if done in
accordance with federal rules for electronic prescriptions set forth in 21 C.F.R. Parts 1300, 1304,
1306, and 1311, as amended).
Electronic Records
225 ILCS 85/18 - There shall be kept in every drugstore or pharmacy a suitable book, file, or electronic
record keeping system in which shall be preserved for a period of not less than 5 years the original, or an
exact, unalterable image, of every written prescription and the original transcript or copy of every
verbal prescription filled, compounded, or dispensed, in such pharmacy; and such book or file of
prescriptions shall at all reasonable times be open to inspection to the pharmacy coordinator and the duly
authorized agents or employees of the Department. Every prescription filled or refilled shall contain the
unique identifiers of the persons authorized to practice pharmacy under the provision of this Act who fills or
refills the prescription.
Electronic Visual Image Prescriptions.
If a pharmacy's computer system can capture an unalterable electronic visual image of the prescription drug
order, the electronic image shall constitute the original prescription and a hard copy of the prescription drug
order is not required. The computer system must be capable of maintaining, printing, and providing, upon a
request by the Department, the Department's compliance officers, and other authorized agents, all of the
prescription information required by State law and regulations of the Department within 72 hours of the
request.
• Note: This includes CIIs. System must comply with DEA eRx standards
Customized Medication Packaging
Illinois permits a pharmacy to dispense medications in customized packages, which allows a daily regimen of
medication to be combined into blisters or other types of containers according to time of day, to enhance
patient compliance. The law provides:
68 IL ADC Section 1330.740 Multi-Med Dispensing Standards for Community Pharmacies

(a) In lieu of dispensing 2 or more prescribed drug products in separate containers, a pharmacist may, with
the consent of the patient, the patient's caregiver, or a prescriber, provide a customized patient medication
package (patient med pak).
(b) A patient med pak is a package prepared by a pharmacist for a specific patient comprising a series of
containers and containing 2 or more prescribed solid oral dosage forms. The patient med pak is designed, or
116
each container is labeled, to indicate the day and time or period of time when the contents within each
container are to be taken.
(1) The patient med pak shall include information stating:
(A) The name of the patient;
(B) A serial number for the patient med pak itself and a separate identifying serial number for each of the
prescription orders for each of the drug products contained in the med pak;
(C) The name, strength, physical description or identification, and total quantity of each drug product
contained in the med pak;
(D) The directions for use and cautionary statements, if any, contained in the prescription order for each
drug product contained in the med pak;
(E) Any storage instructions;
(F) The name of the prescriber of each drug product;
(G) The date of preparation of the patient med pak; and
(H) The name, address and telephone number of the pharmacist and any other registrant involved in
dispensing.
(2) Once a patient med pak has been delivered to an institution or to a patient, the drugs dispensed in the
med pak can be accepted for return by the pharmacy only when a medication must be added or removed, or
when drug therapy is discontinued. Med paks returned to the pharmacy can only be re-dispensed for the
same patient. Medications removed from the med pak shall not be reused and must be disposed of properly.
The revised med pak shall be given a new serial number.
(3) When a pharmacist utilizes drugs dispensed from another pharmacy in creating an initial med pack, that
pharmacist shall bear full responsibility for the drugs as if dispensed from that pharmacy; otherwise, a
pharmacy is prohibited from creating a patient med pak utilizing drugs dispensed from a different pharmacy.
Vaccinations / Immunizations (68 IL ADC 1330.50)

Qualifications
• A pharmacist, or student pharmacist, may administer vaccinations / immunizations pursuant to a
valid patient specific prescription or a standing order by a physician.
o NOTE: Illinois law has changed regarding the age of the patient who can receive an
immunization or vaccination from a pharmacist. The law now provides:
 A pharmacist is permitted to administer Influenza (inactivated influenza vaccine
and live attenuated influenza intranasal vaccine) and Tdap (defined as tetanus,
diphtheria, acellular pertussis) vaccines to patients 10 years of age and older
 For all other vaccines, the patient must be 14 years of age or older.
o The pharmacist must have either a valid prescription, a standing order from a physician, or
pursuant to hospital pharmacy and therapeutics committee policies and procedures.
 Note: Standing order can come from ANY physician; need not be the patient's own
physician.
• The pharmacist shall successfully complete a course of training accredited by ACPE or similar health
authority or professional body approved by the Division.
• The pharmacist shall maintain a current Basic Life Support Certification for Healthcare Providers
issued by the American Heart Association or the American Red Cross.
• Each pharmacy or pharmacist functioning outside of a pharmacy shall have available a current copy
or electronic version of the CDC reference “Epidemiology and Prevention of Vaccine – Preventable
Diseases” at the location where vaccinations are administered.
• The administration of vaccines shall be done by a pharmacist or student pharmacist under the direct
supervision of a pharmacist.
Protocols, Policies and Procedures
117
Prior to administrating vaccinations/immunizations to persons who are 14 years of age or older, a
pharmacist or student pharmacist under the direct supervision of a pharmacist must follow protocols written
by a physician licensed to practice medicine in all of its branches for the administration of vaccines and
treatment of severe adverse events following administration of vaccines.
The pharmacy must maintain written policies and procedures for handling and disposal of all used supplies
or contaminated equipment.
The pharmacist or student pharmacist under the direct supervision of a pharmacist must give the appropriate
vaccine information statement (VIS) to the patient or legal representative prior to each vaccination. The
pharmacist or student pharmacist under the direct supervision of a pharmacist must ensure that the adult
patient or minor (age 10 and older for influenza and Tdap, age 14 or older for all other vaccines) patient’s
parent or legal representative is available and has the vaccine information statement.
The pharmacy must report adverse events as required by the Vaccine Adverse Events Reporting System
(VAERS) and to the primary care provider named by the patient.
Record Keeping and Reporting

All records regarding each administration of a vaccine must be kept for 5 years. These records shall include:
• The name, address and date of birth of the patient.
• Date of administration and site of injection of the vaccine.
• Name, dose, manufacturer, lot number and beyond use date of the vaccine.
• Name and address of the patient’s primary health care provider named by the patient.
• The name or unique identifier of the administering pharmacist.
• Which vaccine information statement (VIS) was provided.
A pharmacist who administers any vaccine must report that administration, within 30 days after the date of
administration, to the patient’s primary healthcare provider named by the patient.
Parenteral Product Standards

Definitions
Barrier Isolation Chamber – an appartus designed to provide a Class 5, 6 or 7environment as spelled out in
the ISO 14644-1 for preparation of sterile products using solid walls rather than air movement (laminar air
flow) to create a critical zone for product handling, a HEPA filtration system that conditions the air flowing
through the unit to remove initial particles and particles generated within the controlled environment, and a
means by which products are introduced and people interact with the product being prepared within the unit.
Biological Safety Cabinet - containment unit suitable for the preparation of low to moderate risk agents when
there is a need for protection of the product, personnel and environment, according to ISO 14644-1.
Compounded Sterile Preparation - a sterile pharmaceutical that has been prepared by a pharmacist, or under
the supervision of a pharmacist. It shall be a preparation prepared for or in anticipation of a specific patient
prescription or medication order issued by a prescribing practitioner. The preparation may include
commercially available dosage forms that may need to be altered by the pharmacist to meet a specific
patient's need.
Cytotoxic - a pharmaceutical that has the capability of killing living cells. These agents shall include, but are
not limited to, agents classified as cancer chemotherapeutic, carcinogenic, mutagenic and antineoplastic.
118
Laminar Airflow Hood – appartus designed to provide a Class 5, 6 or 7 environment as spelled out in the ISO
14644-1 for preparation of sterile products using air circulation in a defined direction that passes through a
HEPA filter to remove the initial particles and particles generated within the controlled environment.
Parenteral - sterile preparations of drugs for injection through one or more layers of the skin.
Terminal - a patient whose medical condition indicates his/her life expectancy to be 6 months or less.
Physical Requirements of Pharmacies Preparing Sterile Parenteral Products
The pharmacy shall have a designated area for preparing compounded sterile preparations. The area shall be
designed to minimize outside traffic and airflow disturbances from activity within the facility. It shall be of
sufficient size to accommodate a laminar airflow hood, barrier isolation chamber or biological safety cabinet
and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature,
light, moisture, sanitation, ventilation and security. It shall be ventilated in a manner not interfering with the
proper operation of the parenteral products preparation apparatus.
The licensed pharmacy preparing sterile parenteral products shall have the following:
• Laminar airflow hood workstation
o Laminar airflow equipment shall be certified annually in accordance with ISO 14644-1.
o In the event the preparation apparatus is moved from its site of certification,
recertification shall occur.
o Prefilters must be replaced or cleaned monthly and documentation of this maintained;
• Sink with hot and cold running water, which is convenient to the compounding area;
• National Institue for Occupational Safety and Health (NIOSH) approved disposal containers for used
needles, syringes, etc., and if applicable, cytotoxic waste from the preparation of chemotherapy
agents;
• Biohazard cabinetry for environment control when cytotoxic ocmpounded sterile preparations are
prepared;
• Refrigerator and/or Freezer with a thermometer;
• Temperature controlled container for off site deliveries.
The following current resource materials and texts shall be maintained in the pharmacy:
•
• American Hospital Formulary Service;
• Copies of the Illinois Pharmacy Practice Act and Rules, the Illinois Controlled Substances Act
and 77 Ill. Adm. Code 3100, 21 CFR and the Illinois Hypodermic Syringes and Needles Act [720
ILCS 635];
• One compatibility reference such as:
o Trissel's Handbook on Injectable Drugs;
o King's Guide to Parenteral Admixtures; or
o Any other DPR approved publication.
• A file on extended (more than 24 hours) stability data given to finished products.
Staffing
A pharmacist shall be accessible at all times at each licensed facility to respond to patients' and health
professionals' questions and needs. A 24-hour telephone number will be included on all labeling of
compounded medication and medication infusion devices if off site.
119
Drug Distribution and Control
Patient Profile or Medication Record System. A pharmacy generated patient profile or medication record
system must be separate from the prescription file. The patient profile or medication record system shall
contain, at a minimum:
• Patient's full name;
• Date of Birth or Age;
• Sex;
• Sterile products dispensed;
• Date dispensed, if off site;
• Drug content and quantity;
• Patient directions, if preparation being administered off site;
• Identifying number;
• Identification of dispensing pharmacist and, if applicable, pharmacy technician;
• Other drugs or supplements the patient is receiving, if provided;
• Known drug sensitivities and allergies to drugs and foods;
• Diagnosis; and
• Lot numbers of components or individual medicine if product is not used within 48 hours of
preparation.
Labeling
Each parenteral product dispensed to patients shall be labeled with the following information with a
permanent label:
• Name, address and telephone number of the licensed pharmacy, if not within facility;
• Administration date and identifying number if used on site, date dispensed and identifying number if
used off site;
• Patient's full name and room number, if applicable;
• Name of each drug, strength and amount;
• Directions for use and/or infusion rate if used off site;
• Prescriber's full last name if used off premises;
• Required controlled substances transfer warnings, when applicable;
• Beyond use date and time;
• Identity of pharmacist compounding and dispensing, or other authorized individual; and
• Auxiliary labels and storage requirements, if applicable.
Recordkeeping
The pharmacist-in-charge shall ensure that records are maintained for 5 years and are readily retrievable in a
format that provides enforcement agents an accurate and comprehensive method of monitoring distribution
via an audit trail. The records shall include at least the following information:
• Patient profile;
• Medication Record System;
• Purchase records; and
• Lot numbers of the components used in compounding sterile prescriptions/orders traceable to a
specific patient, if not included on patient profile and if the product is not utilized within 48 hours of
preparation.
120
Delivery Service
The pharmacist-in-charge shall assure the environmental control of all products shipped or delivered off site.
Therefore, any compounded, sterile pharmaceutical must be shipped or delivered to a patient in temperature
controlled (as defined by USP Standards) delivery containers.
Cytotoxic Drugs
The following additional requirements are necessary for those licensed pharmacies that prepare cytotoxic
drugs:
• Safety and containment techniques for compounding cytotoxic drugs shall be used.
• Disposal of cytotoxic waste shall comply with all applicable local, State and federal requirements.
• Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and
outside and shipped in a manner to minimize the risk of accidental rupture of the primary container.
• Must have as a reference Safe Handling of Hazardous Drugs Video Training Program and Workbook
(ASHP). .
Emergency Medications
Pharmacies that dispense compounded sterile preparations to patients in facilities off site or in the patient's
residence shall stock supplies and medications appropriate for treatment of allergic or other common
adverse effects, to be dispensed upon the prescription or order of an authorized prescriber.
Internet Pharmcies – Illinois has adopted the federal Ryan – Haight Act
68 IL ADC Section 1330.60 Internet Pharmacies - The provisions of the federal Ryan Haight Online Pharmacy
Consumer Protection Act of 2008 (Ryan Haight Act) (21 USC 801 et seq.) and all federal regulations adopted
under that Act, are expressly adopted by this Part.
225 ILCS Section 19.1. Dispensing Naloxone Antidotes

(a) Due to the recent rise in opioid-related deaths in Illinois and the existence of an opioid antagonist that can
reverse the deadly effects of overdose, the General Assembly finds that in order to avoid further loss where
possible, it is responsible to allow greater access of such an antagonist to those populations at risk of
overdose.
(b) Notwithstanding any general or special law to the contrary, a licensed pharmacist may dispense an opioid
antagonist in accordance with written, standardized procedures or protocols developed by the Department
with the Department of Public Health and the Department of Human Services if the procedures or protocols
are filed at the pharmacy before implementation and are available to the Department upon request.
(c) Before dispensing an opioid antagonist pursuant to this Section, a pharmacist shall complete a training
program approved by the Department of Human Services pursuant to Section 5-23 of the Alcoholism and
Other Drug Abuse and Dependency Act. The training program shall include, but not be limited to, proper
documentation and quality assurance.
(d) For the purpose of this Section, "opioid antagonist" means a drug that binds to opioid receptors and
blocks or inhibits the effect of opioids acting on those receptors, including, but not limited to, naloxone
hydrochloride or any other similarly acting and equally safe drug approved by the U.S. Food and Drug
Administration for the treatment of drug overdose.
225 ILCS Section 16c. Medication Locking Closure Package

(a) "Medicine locking closure package" means any alphanumeric combination locking closure mechanism that
can only be unlocked with a user-generated, resettable alphanumeric code in combination with an amber
prescription container that forms a package that allows only the person with a prescription access to the
medicine.
"Schedule II controlled substance" means a Schedule II controlled substance under the United States
121
Controlled Substances Act and 21 CFR 1308.
(b) Subject to appropriation, effective January 1, 2016, the Department shall by rule implement a pilot project
requiring that every new or refilled prescription for a Schedule II controlled substance containing
hydrocodone dispensed by a pharmacy that voluntarily decides to participate in the pilot program shall only
be dispensed in a non-reusable medicine locking closure package. The Department shall not expend more
than $150,000 on this pilot program. The Department may contract with third parties to implement the pilot
program in whole or in part.
(c) The medicine locking closure package must be dispensed by the pharmacy with instructions for patient
use unless the prescriber indicates orally, in writing, or electronically that a medicine locking closure package
shall not be used.
(d) The manufacturer of the medicine locking closure package must make available assistance online or
through a toll-free number for patient use.
(e) Prescriptions reimbursed via the Medicare Part D and Medicaid programs, including Medicaid managed
care plans, are exempt from the provisions of this Section.
(f) Prescriptions for individuals residing in facilities licensed under the Nursing Home Care Act are exempt
from the provisions of this Section.
122
Illinois State Wholesaler Laws
Enacted pursuant to the federal Prescription Drug Marketing Act of 1987

"Wholesale drug distributor" - any person or entity engaged in wholesale distribution of prescription drugs,
including, but not limited to, manufacturers; repackers; own label distributors; jobbers; private label
distributors; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug
warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies
that conduct wholesale distributions, including, but not limited to, any pharmacy distributor as defined in
this Section. A wholesale drug distributor shall not include any for hire carrier or person or entity hired
solely to transport prescription drugs.
Exemptions
"Wholesale distribution" or "wholesale distributions" means distribution of prescription drugs to persons
other than a consumer or patient, but does not include any of the following:
• Intracompany sales, (any transaction or transfer between any division, subsidiary, parent, or
affiliated or related company under the common ownership and control of a corporate entity).
• The purchase or other acquisition by a hospital or other health care entity that is member of a group
purchasing organization of a drug for its own use from the purchasing group organization or from
the other hospitals or health care entities that are members of a group organization.
• The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable
organization . . . to a nonprofit affiliate of the organization to the extent otherwise permitted by law.
• The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or
other health care entities that are under common control. For purposes of this Act, "common
control" means the power to direct or cause the direction of the management and policies of a person
or an organization, whether by ownership of stock, voting rights, contract, or otherwise.
• The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency
medical reasons. For purposes of this Act, "emergency medical reasons" include transfers of
prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage,
• The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a
drug, pursuant to a prescription.
• The distribution of drug samples by manufacturers' representatives or distributors' representatives.
• The sale, purchase, or trade of blood and blood components intended for transfusion.
Pharmacy Distributor
A pharmacy engaged in the distribution of prescription drugs either to any other pharmacy, or to any other
person or entity, including but not limited to a wholesale drug distributor engaged in the delivery or
distribution of prescription drugs to other than the ultimate consumer.
Five Percent Rule

"Wholesale distribution" or "wholesale distributions" means distribution of prescription drugs to a person
other than consumer or patient, but does not include:
• The sale of prescription drugs by a pharmacy to practitioners (i.e., licensed physicians, dentists,
veterinarians or podiatrists), providing the sales do not exceed 5% of the annual dollar purchases
of prescription drugs by the pharmacy and providing the pharmacy maintains a log of sales to
practitioners that includes: (1) Date of sale; (2) Practitioner's name and address; (3) Drug and
strength; (4) Size of package; and (5) Quantity sold.
123
It is unlawful for any person or entity to knowingly purchase or receive any prescription drug from any
source other than a person or entity licensed under the laws of this state or the state of domicile.
MISCELLANEOUS STATE AND FEDERAL LAWS
Hypodermic Syringes and Needles Act (720 ILCS 635)

A criminal statute intended to prevent use of hypodermic syringes and needled in connection with drugs of
abuse. Only persons and entities identified in the Act are authorized to possess syringes and needles.
Key Points
Not part of Pharmacy Practice Act or regulations. Ambiguities exist regarding sales by pharmacists.
Pharmacists may dispense syringes and needles to patients pursuant to a prescription. However, sales
without a prescription are also permitted.
The following are the requirements for sale of a syringe or needle without a prescription:
• A person 18 years or older may purchase up to 100 sterile hypodermic syringes daily without a
prescription from a pharmacist in the pharmacy department of the pharmacy
• Syringes or needles sold under this subsection must be stored at a pharmacy in a manner that limits
access to the syringes or needles to pharmacists employed at the pharmacy or persons designated by
the pharmacists
• There are no record keeping requirements
• Illinois Department of Public Health must provide materials for proper disposal of needles and
syringes to the pharmacies that choose to sell them
NOTE: If dispensing needles and syringes pursuant to a prescription, the prescription, record keeping, refill,
and labeling requirements applicable to prescriptions for non-controlled substances must be followed! The
new law applies only when dispensing without a prescription.
Illinois Cannabis Control Act (1971)

Cannabis is not treated as a Schedule I controlled substance under Illinois state law.
A criminal statute, designed to remove cannabis from the criminal penalty scheme applicable to other
controlled substances. Possession and use is still subject to criminal sanctions, but penalties are less severe,
and courts have greater latitude in deciding the appropriate penalty and sentencing.
Illinois Medical Marijuana Act
• The sale of medical marijuana is not considered to be part of the practice of pharmacy and will NOT
be on the exam.
Poison Prevention Packaging Act

Enforced by the Consumer Products Safety Commission. Purpose of law is to provide special packaging to
protect children under the age of 5 from accidental poisoning.
Safety Caps
All new and refilled prescriptions must have a child resistant closure unless:
• the prescriber specifies none is to be used; applies only to individual prescriptions, cannot make
blanket waiver.
124
• the patient indicates they do not want a safety cap. The patient may provide a blanket authorization
for non-child resistant caps. However, authorization for a single prescription cannot be used to
justify use of a non-child resistant cap for future prescriptions.
When refilling a prescription, both parts of the plastic container must be replaced; for glass bottles, it is
permissible to reuse the glass container, but the plastic cap must be replaced.
Some products are exempt from the PPPA. Examples include:

• sublingual nitroglycerin tablets;
• sublingual and chewable isosorbide dinitrate tablets in doses of 10 mg. or less;
• effervescent aspirin or acetaminophen tablets;
• oral contraceptives packaged in “dial-packs”;
• unit dose potassium supplements;
• cholestyramine and colestipol powder;
• aerosol inhalation products.
Exam Tip: When evaluating a drug for purposes of whether it needs to be dispensed with a safety cap, a
good rule of thumb is if it was packaged by the manufacturer with a safety cap, it should be dispensed
with a safety cap. If it came from the manufacturer without a safety cap, it can likely be dispensed
without a safety cap.
Obtaining Consent/Authorization to Dispense without a Safety Cap

If a patient requests no safety cap, it can be dispensed without a safety cap. The patient can give consent for
all prescriptions ever dispensed from the pharmacy. No special form required. No signature required.
A physician can indicate on the prescription that a safety cap is not required. However, the consent or
authorization provided by the doctor applies ONLY to that drug, and any subsequent refills on the same
prescription.
Iron supplements
Products containing 30 mg. of elemental iron must be packaged in unit dose containers; containers with more
than 250 mg. of elemental iron must be child-resistant.
NOTE: This section has been revised, as a result of a court challenge to the FDA’s rulemaking authority. The
new rule issued by FDA requires that the following warning label be placed on iron products:
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in
children under 6. Keep this product out of reach of children. In case of accidental overdose, call a
doctor or poison control center immediately.
It is not clear whether pharmacists are required to place this warning on prescription labels of the products
they dispense, or whether it applies only to the original product manufacturer.
The requirement of packaging in unit dose containers no longer applies, but the child resistant packaging
requirement remains in place.
On the MPJE®, review the question and possible answers carefully, and answer as though the new
requirement applies to pharmacy.
Pharmaceutical Grade Alcohol

125
Alcohol should not be much of an issue on the MPJE®. However, here is some information concerning alcohol
that can be used in pharmacies, which you might need to know:
• Alcohol sales are regulated by the Bureau of Alcohol, Tobacco and Firearms (not by FDA or DEA).
• Pharmacies can purchase 95% ethanol (which is 190 proof grain alcohol) for routine compounding
using Form ATF-11.
• Institutions that have a greater need for alcohol can purchase tax free alcohol using form ATF-1447.
• Alcohol purchased with these forms is limited to medicinal or scientific use, or in patient treatment.
• Tax free alcohol cannot be sold on an outpatient basis, either alone or as a component in a
compounded product. It is for inpatient use only. The only exception is that a nonprofit clinic can
dispense medicines made using tax free alcohol, but only if the patient is not charged for the
medication. Tax free alcohol also cannot be sold to other pharmacies or to physician offices.
• Accurate inventory records must be maintained.
There are other types of alcohols available that are also tax-exempt. These are "specially denatured alcohols",
which is a specially formulated grain alcohol that is unfit for consumption. They are used by drug companies
for pharmaceutical processing, and in small quantities in commercial products, including some mouthwashes.
Alcohol is NOT a controlled substance. Occasionally, a doctor might prescribe conventional alcohol (brandy,
scotch, etc.) for a patient (i.e., “2 ounces of brandy as needed to assist with sleep”). If that is done, there is no
law that precludes a pharmacy from selling the alcohol pursuant to the prescription. However, for non-
prescription, retail sales of alcohol, the pharmacy must have a retail liquor dealer’s stamp from ATF, and will
also likely need a liquor license issued by the local government (city, village, county, state) where the
pharmacy is located.
126
Frequently Asked Questions & Tips
Q: I am confused about the length of time certain records must be maintained in Illinois. My
confusion stems from differences between state and federal law. Can you clarify?
A: RECORD KEEPING: TWO VERSUS FIVE YEARS. Initially, there is no federal law that addresses
recordkeeping for non-controlled substances. Therefore, Illinois law governs for all non-controlled substance
records.
For controlled substances, Illinois law is stricter, and requires that certain records be maintained for a longer
period of time than is required under federal law.
• Purchase Records/Invoices (controls and non-controls): 5 years in total, at least 1 year onsite (all
legend drugs) - Ill. Admin. Code tit. 68, § 1330.660.
• DEA 222 forms: Illinois law considers DEA 222s to be an "invoice," and therefore requires that they
be maintained for 5 years. Two years - 21 C.F.R. § 1305.17(c)
• DEA form 106 - Two years.
• Illinois annual inventory of controlled substances: 5 years in total, at least 1 year onsite (all legend
drugs) - Ill. Admin. Code tit. 68, § 1330.660
• Records of disposal of controlled substances: Two years, must retain DEA form 41. 21 C.F.R. § 1317.
Under federal law, records are to be maintained for two years. The types of records DEA requires a pharmacy
to maintain for two years are:
• Executed and unexecuted official order forms (DEA Form 222) or the electronic equivalent, must be
maintained separately from all other records of the registrant. DEA Forms 222 are required to be
kept available for inspection for a period of two years. 21 C.F.R. § 1305.17(c).
• Power of Attorney authorization to sign order forms.
• Receipts and/or invoices for schedules III, IV, and V controlled substances.
• All inventory records of controlled substances, including the initial and biennial inventories, dated as
of beginning or close of business.
• Records of controlled substances distributed (i.e., sales to other registrants, returns to vendors,
distributions to reverse distributors).
• Records of controlled substances dispensed (i.e., prescriptions, schedule V logbook).
• Reports of Theft or Significant Loss (DEA Form 106).
• Inventory of Drugs Surrendered for Disposal (DEA Form 41).
• Records of transfers of controlled substances between pharmacies.
Q: What changes may a pharmacist make to a schedule II prescription?
A: A pharmacist is never permitted to change:

• patient's identity;
• the drug prescribed (other than generic substitution);
• the date on the prescription or add a date; or
• identity of the prescriber or the prescriber's signature.
If any of these changes are necessary to properly dispense the Schedule II controlled substance prescribed, a
new written prescription must be obtained from the prescriber.
Any other components of a prescription for a Schedule II controlled substance may be changed after
consultation with the prescriber
127
Note that federal law is silent re: changes to the date. Illinois law changed recently, and no longer permits
the addition of a missing date.
Q: May controlled substances be electronically prescribed by a practitioner?
A: Yes, provided that the system used for transmitting the prescription complies with federal DEA
regulations, and the prescription is valid under federal law. This includes CII prescriptions.
Q: How does one report theft/loss of controlled substances?
A: The registrant is required by federal law (21 CFR 1301.76) to file form 106 with the US Drug Enforcement
Agency whenever a controlled substance is stolen or lost. Illinois requires a copy of the form 106, that has
been filed with the DEA, to be submitted to DPR. Failure to do so may result in disciplinary action against the
pharmacist.
The process to be followed is (1) notify the local DEA field office of the suspected loss or theft within one
business day; and (2) after notice is provided, conduct a thorough investigation, and submit the DEA 106
form after the investigation has been completed. There is no deadline for completing the investigation.
Q. Can a pharmacist refill a prescription after the prescribing practitioner dies, retires or relocates?
A: This question is not specifically addressed in either the Act or the Rules. In the past, DFPR addressed this
issue in a newsletter, and states:
The FDA and National Center for Drugs and Biologics has addressed this issue and has given this
response: a practitioner/patient relationship is signified by the patient receiving a prescription by
his or her practitioner. It is also generally understood that the patient is under the
practitioner's professional care during the life of that prescription, including the number of
authorized refills. The prescription is no longer valid once the practitioner/patient relationship is
broken as the practitioner is no longer treating the patient and overseeing the use of the prescribed
medication. The DFPR recommends that when a pharmacist becomes aware of this type of situation,
he or she should counsel and inform the patient of the need to retain a new practitioner as soon as
possible. The pharmacist, using his or her professional judgment, may provide a sufficient amount of
maintenance medications until the patient is able to retain the services of another practitioner.
Professional judgment questions on the MPJE® are difficult. In a multiple choice exam, look for the answer
that allows you to provide adequate patient care, while also being mindful of the need for the patient to
follow-up with a new physician as soon as practicable. Answers that set arbitrary deadlines (i.e., fill for no
more than 30 days, or fill for no more than 60 days) are not correct. A good option might be to refill the first
time, and counsel the patient it is important to find a new physician.
Q: Which of these is not needed in a pharmacy that makes a parenteral product: Good lighting,
Biological Safety cabinet, Laminar bench, and running water?
A: Biological safety cabinet is not needed. The licensed pharmacy preparing sterile parenteral products shall
have the following:
• Laminar airflow hood which will be certified annually in accordance with Federal Standard 209E
( for horizontal laminar airflow equipment) or National Sanitation Foundation Standard (for vertical
laminar airflow equipment).
• Sink with hot and cold running water, which is convenient to the compounding area
• Refrigerator and/or freezer with a thermometer
• Temperature controlled container for off site deliveries
128
• Environmental Protection Agency approved disposal containers for used needles, syringes, etc, and if
applicable, cytotoxic waste from the preparation of chemotherapy agents and infectious wastes
Q: How often must a laminar air flow hood be certified?
A: Yearly
Q: Who can counsel patients?
A: A pharmacist or student pharmacist acting under the direct supervision of the pharmacist can counsel. If
the question is who can make the offer to counsel, the answer is different. The pharmacist, student
pharmacist, or pharmacy technician can make the offer. Cashiers and other unlicensed personnel
working in the pharmacy can no longer make the offer to counsel.
Q: Can a doctor write prescriptions (controlled and non-controlled) for himself or his family
members?
A: NO. Self-Prescribing or Self-Dispensing of controlled substances is no longer permitted.

A: Also, a practitioner may not prescribe controlled substances to an immediate family member unless there
is a bona fide practitioner-patient relationship and appropriate records are maintained. (Section 3100.380
controlled substance rules)
Q: Which one of these medications is not a controlled substance: Hydrocodone, Empirin, Fiorinal, or
Empirin w/codeine?
A: Empirin is the correct answer. It is important to memorize brand names of drugs.
Q: Pt John Smith brings in a prescription for Prozac 20mg QTY #30, with 3 refills. The patient, who
has a history of suicidal behaviors, would like a quantity of 90 and the insurance will pay for it. You
should:
A. Fill it for 90
B. Fill it for 30
C. Call the insurance company
D. Call the MD and ask if it is ok before dispensing 90
A: The best answer is D under Illinois law. Although you can legally fill it for #90, given the “hint” about
suicidal tendencies, the best answer would be to get the MD’s approval. The same analysis should be used if
the drug is a controlled substance. Legally, you can combine refills, but if the question suggests that
contacting the MD is an option, that would be the best response. The answer implies that you are getting
consent from the MD, and you can assume that if consent is given, you are changing the prescription. B is also
correct, since you “can” dispense 30 like the Rx says, but it is not the best answer.
If the drug was changed to Lasix, for example, and there were facts that showed the patient has been on the
medication and has been compliant, your answer might be different. The law is that you are not required to
get the prescriber’s permission, but you MUST always use professional judgment, and act in the best interest
of the patient.
Q: What is the difference between adulteration and misbranding?
129
A: Adulteration issues are typically directed at the condition of the product. Section 501 of the FDCA
provides that a product is “adulterated” if it consists in whole or in part of any filthy, putrid, or decomposed
substance; or if it has been prepared, packed, or held under unsanitary conditions whereby it may have been
contaminated with filth, or whereby it may have been rendered injurious to health.
Misbranding is directed at the labeling of a product. Section 502 of the FDCA states that a product is
misbranded if its labeling is false or misleading in any particular, if in a package form unless it bears a label
containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate
statement of the quantity of the contents in terms of weight, measure, or numerical count; also, if any word,
statement, or other information is not prominently placed on the label, with such conspicuousness and in
such terms as to render it likely to be read and understood by the ordinary individual under customary
conditions of purchase and use. See the FDA section of the handout for a detailed list of the conditions that
result in misbranding and adulteration.
One exception to the general rule that misbranding goes to the labeling of a product, while adulteration goes
to the condition of the product, is that the FDCA includes the following as a condition of adulteration: drug is
labeled as if recognized in an official compendium, but strength differs from, or quality or purity falls below
compendium standards.
In pharmacy practice, when a medication error occurs (wrong drug in bottle) the product is also deemed to
be both misbranded and adulterated.
Misbranding occurs when a prescription medication is dispensed without a valid prescription or authorized
refill.
Q: When does Controlled Substance dispensing information need to be reported to the PDMP?
A: Illinois requires reporting of all controlled substances dispensed pursuant to a prescription by a pharmacy,
including controlled substances scheduled under Illinois law, but not federal law. Dispensing information
must be turned to DHHS by the end of the next business day. The laws in other states may be different, so
be careful if taking the exam in multiple states.
Q: Are pentazocine combination products (i.e. pentazocine + APAP) also considered schedule II
medications in Illinois?
A: When combined with ASA, APAP, or Naloxone, Pentazocine is considered a schedule III (not II) medication.
Thus, the following are considered C-III products under Illinois law:
• Any material, compound, or preparation containing not more than 12.5 mg of pentazocine or any of
its salts, per 325 milligrams of aspirin;
• Any material, compound, or mixture or preparation containing not more than 12.5 mg of pentazocine
or any if its salts, per 325 mg of acetaminophen;
• Any material, compound, mixture, or preparation containing not more than 50mg of pentazocine or
any of its salts plus naloxone HCl USP 0.5mg, per dosage unit.
Products containing just pentazocine, and no other active ingredient, are treated as C-IIs under Illinois law.
Q: Is it important to be familiar with various types of insulin?
A: YES! Become familiar with various types of insulin, and be able to identify which require a prescription,
and which insulins do not (Humilin brand insulin)
130
Q: Which insulin(s) are available OTC?
A: Humulin R, Humulin N, and Humulin Ultra Lente are available without a prescription. There may be others,
so please check available references.
Q: What are DESI drugs?
A: DESI means “Drug Efficacy Study Implementation”, and is a process whereby the FDA is reviewing all old
drugs- drugs that were approved before the FDA approval standards required proof of efficacy. Proof of
efficacy was first required in 1962 by the Kefauver-Harris Amendments to the Food Drug and Cosmetic Act.
All drugs approved before 1962 were required to undergo DESI review. There are still many drugs that are
on the market, but which have not yet been reviewed. Those drugs are referred to as “DESI” drugs. Another
fact about DESI drugs is that they are not listed in the FDA orange book for equivalency purposes. In other
words they are not “A” rated and cannot be substituted.
The “Orange Book” is the Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic
Equivalence Evaluations.
• All FDA-approved drug products listed
• Therapeutic equivalence codes – first letter (“prefix”) refers to equivalency rating
o “A” = Substitutable
o “B” = Inequivalent, NOT Substitutable
o Second letter refers to dosage form
 AB – Solid dosage form
 AN - Solutions and powders for aerosolization
 AO - Injectable oil solutions
 AP - Injectable aqueous solutions and, in certain instances, intravenous non-
aqueous solutions
 AT - Topical products.
• FDA now requires a demonstration of bioequivalence before an ANDA can be approved
• Products for which in vivo demonstration of BE was deferred are listed as therapeutic inequivalent
or “B” rated
• Those still appearing in the Orange Book are about 3%—FDA does not have data demonstrating
equivalence or inequivalence
• Products found not to be bioequivalent are no longer being approved
Q: What are illegal kick-backs?
A: Receiving any type of remuneration - money, gifts, anything of value – in exchange for a referral. Giving
doctors a free PDA for e-prescribing in exchange for an agreement that he will send the prescriptions to your
pharmacy is an example. Providing a doctor free office space in your building, next to your pharmacy, in
exchange for his agreement to send patients to you, is another.
Coupons for patients also raise concerns for Medicare and Medicaid patients. Federal law prohibits offering
inducements to federal beneficiaries to try to persuade them to fill prescriptions or obtain other federally
reimbursable health care services. This is why most pharmacy chains that issue coupons exclude
participation of patients who have their prescriptions paid for by any state or federal payment program.
Q: What is the federal and state emergency C-II dispensing quantity limit? (is it 3 days worth??)
A: Federal and state would both limit dispensing to an amount that will get the patient through the
emergency period. There is no arbitrary # of day’s limitation - it is based on the facts and circumstances
presented. For example, if the patient needs the medication, and cannot see the doctor to get a written RX for
131
2 weeks, then the pharmacist could dispense a 2 week supply pursuant to an emergency prescription phoned
in by the doctor.
Many students have been asking me about a 3 day limit. This is an example of widespread misinformation that is
legally incorrect.
Q: When Doctors are ordering a CII controlled substance “for office use”, do they need to fill out a DEA
222?
A: Yes.
Q: What about CIII – CV controlled substances “for office use”?
A: The order must be placed on a purchase order or invoice, and not on a prescription that identifies the
doctor as the patient, with directions for use stating “For Office Use”. Also, the order should not be processed
as a prescription, and should not be filed with prescription records. It should be treated as a wholesale
transaction, and filed with those records.
Q: Is a pet owner's name required to be on a prescription for a pet in addition to the pet's name? And,
if so, do you think this refers to placing an owner's full name like TOM SMITH along with his dog's
name FIDO SMITH on the Rx?? or is it sufficient just to add the owner's last name of SMITH to the pet's
first name??
A: Last name is sufficient - "Fido Smith". For controlled substances, the Rx requires the full name and address
of the animal owner, as well as the species or common name of the animal being treated.
Q: If, as a pharmacist, your license expires (you forget to renew it in time), can you still work?
A: If your license is expired, you are unlicensed, and cannot practice until it is reinstated. Here is the process
for reinstatement of an expired license:
Restoration, 68 IL ADC Section 1330.90

A registrant seeking restoration of a certificate of registration that has expired for 5 years or less shall have
the license restored upon payment of all lapsed renewal fees required by Section 1330.20and proof of 30
hours of continuing education (e.g., certificate of attendance or completion) in accordance with Section
1330.100 of this Part.
A registrant seeking restoration of a certificate of registration that has been placed on inactive status for 5
years or less shall have the license restored upon payment of the current renewal fee and proof of 30 hours of
continuing education (e.g., certificate of attendance or completion) in accordance with Section 1330.100 of
this Part.
A registrant seeking restoration of a certificate of registration after it has expired or been placed on inactive
status for more than 5 years shall file an application, on forms supplied by the Division, together with the fee
required by Section 1330.20and proof of 30 hours of continuing education (e.g., certificate of attendance or
completion) in accordance with Section 1330.100 of this Part. The registrant shall also submit either:
• Certification of active practice in another jurisdiction. Evidence shall include a statement from the
appropriate board or licensing authority in the other jurisdiction that the registrant was authorized
to practice during the term of active practice;
• An affidavit attesting to military service as specified in Section 12 of the Act. The applicant restoring a
license shall be excused from the payment of any lapsed fee or any restoration fees.
132
• A registrant who is unable to submit proof of satisfaction of either subsection (c)(1) or (2) shall
submit proof of completion of:
 600 hours of clinical practice under the supervision of a licensed pharmacist completed within 2
years prior to restoration; or
 Successful completion of the Pharmacist Assessment for Remediation Evaluation (PARE)
examination. To be successful, an applicant must receive an overall score of 80 or higher, as well
as a minimum score of 75 in each of the 3 content areas on the PARE examination
• The course work or clinical training described in subsections (c)(2)(A) and (c)(2)(B)(i) shall have the
prior approval of the Board.
• When the accuracy of any submitted documentation, or the relevance or sufficiency of the course
work or experience is questioned by the Division because of lack of information, discrepancies or
conflicts in information given, or a need for clarification, the registrant will be requested to:
o Provide such information as may be necessary; and/or
o Appear for an interview before the Board to explain such relevance or sufficiency, clarify
information given, or clear up any discrepancies in information.
Q: Does anything happen to you for the few days that you were practicing without a valid license??
A: You are subject to discipline for practicing without a license. Here is the section of the PPA that addresses
that:
Any licensee who shall engage in the practice for which his or her license was issued while the
license is expired or on inactive status shall be considered to be practicing without a license which,
shall be grounds for discipline under Section 30 of this Act. Any pharmacy operating on an expired
license is engaged in the unlawful practice of pharmacy and is subject to discipline under Section 30
of this Act. A pharmacy whose license has been expired for one year or more may not have its license
restored but must apply for a new license and meet all requirements for licensure. Any pharmacy
whose license has been expired for less than one year may apply for restoration of its license and
shall have its license restored.
Q: When can inspectors come into pharmacy and what kind of information can they seek?
A: Inspectors have broad powers to inspect pharmacists and pharmacies in order to ensure compliance with
the PPA and rules. They can enter pharmacies during regular business hours, and can seek any information
that has anything to do with the practice of pharmacy including prescriptions, invoices, various forms
(including federal forms), licenses, applications, etc.; any record a pharmacy is required to maintain. For
MPJE® purposes, interpret this very broadly. For example, I do not think that inspectors have the right,
without a subpoena, to obtain incident reports, or medication error reports, since pharmacies maintain those
types of records voluntarily. The Department disagrees with this view, however. On the exam, if that type of
question is asked, you can assume that since an inspector can investigate incompetence, and an error report
may be evidence of incompetence, it can be reviewed by an inspector.
Record retention
Except as provided in subsection (b), there shall be kept in every drugstore or pharmacy a suitable
book, file, or electronic record keeping system in which shall be preserved for a period of not less
than 5 years the original of every written prescription and the original transcript or copy of every
verbal prescription filled, compounded, or dispensed, in such pharmacy; and such book or file of
prescriptions shall at all reasonable times be open to inspection to the pharmacy coordinator and the
duly authorized agents or employees of the Department.
Sec. 35.2. The Department's pharmacy investigators may investigate the actions of any applicant or of
any person or persons holding or claiming to hold a license or registration. The Department shall,
133
before suspending, revoking, placing on probationary status, or taking any other disciplinary action
as the Department may deem proper with regard to any license or certificate, at least 30 days prior to
the date set for the hearing, notify the accused in writing of any charges made and the time and place
for a hearing of the charges before the Board, direct him or her to file his or her written answer
thereto to the Board under oath within 20 days after the service on him or her of such notice and
inform him or her that if he or she fails to file such answer default will be taken against him or her
and his or her license or certificate may be suspended, revoked, placed on probationary status, or
have other disciplinary action, including limiting the scope, nature or extent of his or her practice,
provided for herein. Such written notice may be served by personal delivery or certified or registered
mail to the respondent at his or her address of record . At the time and place fixed in the notice, the
Board shall proceed to hear the charges and the parties or their counsel shall be accorded ample
opportunity to present such statements, testimony, evidence and argument as may be pertinent to
the charges or to the defense thereto. Such hearing may be continued from time to time. In case the
accused person, after receiving notice, fails to file an answer, his or her license or certificate may in
the discretion of the Director, having received first the recommendation of the Board, be suspended,
revoked, placed on probationary status, or the Director may take whatever disciplinary action as he
or she may deem proper as provided herein, including limiting the scope, nature, or extent of said
person's practice, without a hearing, if the act or acts charged constitute sufficient grounds for such
action under this Act.
Sec. 5.5. Unlicensed practice; violation; civil penalty.

Any person who practices, offers to practice, attempts to practice, or holds oneself out to practice
pharmacy without being licensed under this Act shall, in addition to any other penalty provided by
law, pay a civil penalty to the Department in an amount not to exceed $5,000 for each offense as
determined by the Department. The civil penalty shall be assessed by the Department after a hearing
is held in accordance with the provisions set forth in this Act regarding the provision of a hearing for
the discipline of a licensee.
The Department has the authority and power to investigate any and all unlicensed activity.
Q: Must inspectors be pharmacists?
Yes. Note that Illinois law has changed, and inspectors are once again required to be pharmacists. However,
inspectors who were not pharmacists, if hired before the law took effect in August 2015, can continue to be
inspectors.: "Each pharmacy investigator shall be a licensed pharmacist unless employed as a pharmacy
investigator on or before the effective date of this amendatory Act of the 99th General Assembly."
Q: Are they ever not allowed into the pharmacy?
A: For MPJE® purposes, the answer is no, provided that they are inspecting pharmacy issues, and the
inspection is during normal business hours.
Q: When they request information, what is the turn-around time that the pharmacy must send
information to them by?
A: The section of the Act that addresses grounds for discipline states:
(225 ILCS 85/30) (from Ch. 111, par. 4150)
Sec. 30. (a) In accordance with Section 11 of this Act, the Department may refuse to issue, restore, or
renew, or may revoke, suspend, place on probation, reprimand or take other disciplinary action as
the Department may deem proper with regard to any license or certificate of registration for any one
or combination of the following causes:
Failing, within 60 days, to respond to a written request made by the Department for information.
134
Q: Assume the doctor gives the patient 3 prescriptions at the same appointment dated 5/20, 6/20, and
7/20. On 5/21, the patient asks the pharmacist to fill the first RX, and to hold the other 2 for a later fill.
Is this legal?
A. NO! Post-dating a prescription is NOT permitted. The date of issuance must reflect the date the patient is
seen and/or the prescription is written.
Q. What if the doctor dates the three prescriptions “5/20/18”, but writes on the second RX “do not fill
until 6/19/18” and on the third “do not fill until 7/19/18”. Would these RXs be valid?
A: YES. Remember that in the past, a CII RX was valid for 7 days from the date of issuance, regardless of the
date that is written on the RX, or any instructions by the prescriber asking that the prescription be filled at a
later date. The result was that this type of prescribing would not work, because when the patient appeared at
the pharmacy on 6/19, the RX would have expired. Now, Illinois law provides that a CII RX expires 90 days
after the date of issuance, so these prescriptions are valid. The DEA also endorses this practice.
.
Q: IL has no limits regarding the quantity a doctor can write on controlled substance RXs. Is that true
for mid-level practitioners as well?
A: Yes, for CIII - CV. Professional judgment and good faith are the keys. Remember, however, that for CIIs,
only a 30 day supply is permitted.
Q: If a drug is dropped on the ground, is it adulterated?
A: Yes. See the definition of adulteration in the notes. Even if you have a clean floor, the drug could become
contaminated, and is therefore adulterated. Actual contamination is not required for a finding of a violation.
Q: If there is a fire in the front of the pharmacy, but the flames do not reach the pharmacy area, where
the medications are stored, can you use them? Only if they are sealed? Who needs to be notified that
the fire occurred?
A: Even if the flames do not reach the pharmacy, the heat and smoke generated by the fire could adversely
affect the drugs. They are therefore considered to be adulterated. It does not matter if the package is sealed
or unsealed. There is no requirement that any state or federal agency be notified of the fire.
Q: If you see an impaired pharmacist on the job, who must you notify? Who would discipline the
impaired pharmacist?
A: While there is no duty to notify anyone, the best answer would be to report the conduct to the Department
of Financial and Professional Regulation. IDFPR is also the entity that would discipline the impaired
pharmacist. Remember also that you could be disciplined if you do not report, based on the theory that you
have aided and assisted the pharmacist in his violation of the law, who violated the law by working while
impaired. Any time questions appear on the exam that ask whether conduct could subject the pharmacist to
discipline, think of the enumerated grounds for discipline, but in a close question, err on the side of choosing
the answer that says yes, the pharmacist can be disciplined.
Q. If a Pharmacy compounds a certain amount of Prescriptions per month, is there a maximum

amount it can compound in anticipation for the next month? Or do they just compound an
anticipation of that amount?
A: Just compound in anticipation of receiving prescriptions, based on historical number of prescriptions

received for that product.
135
Q. Is the NDC number required on all OTC products?
A: Yes. Here is more info on NDCs:
The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug
Administration (FDA) with a current list of all drugs manufactured, prepared, propagated,
compounded, or processed by it for commercial distribution. Drug products are identified and
reported using a unique, three-segment number, called the National Drug Code (NDC), which is a
universal product identifier for human drugs.
• The number is a series of 10 or 11 digits that are designed to identify the manufacturer, the drug, and
the package size.
NOTE: NDC numbers are NOT required to appear on a prescription label.
Q. Can a C2 Prescription be postmarked within 7 days of the Emergency C2 fill rather than received
within the 7 days? And the Pharmacist needs to contact DEA, DHS, and DASA if Prescription is not
received?
A: Yes. Under both Illinois and Federal Law.

• Illinois Law provides: “The written prescription may be delivered to the pharmacist in person, or by
mail, but if delivered by mail it must be postmarked within the 7-day period”.
• Federal Law States: “in the case of an emergency situation, as defined by the Secretary in Sec. 290.10
of this title.....if delivered by mail, it must be postmarked within the 7 day period.”
Q. Is it correct that according to the FDA, if you take OTC products and repackage them and then sell
them WITHOUT A PRESCRIPTION, you need a manufacturer’s license.
A: Yes, unless it is a hospital that is re-packaging for its own internal use. Of course, if you are presented with
a prescription for an OTC product, that is not re-packaging, that is dispensing.
Q. If both boxes (substituted and daw) are checked for a Coumadin RX, can the generic be dispensed
without talking to the doctor.
A: In that case, if both boxes are checked, I would answer that you must call the Doctor. By checking “May Not
Substitute” the prescriber is prohibiting substitution, even if he also checked “May Substitute”
Q. When the doctor writes “medically necessary” on the script, what does that mean?
A: This is a phrase that is used to prevent substitution in some states for Medicare and Medicaid prescriptions.
IT HAS NO MEANING UNDER ILLINOIS LAW. THEY MAY BE GETTING AT THE REQUIREMENT (IN SOME
STATES AND UNDER MEDICAID) THAT THE BRAND NAME DRUG BE DISPENSED. If you get a question like
this, answer that you need to call the doctor to obtain permission to dispense the generic.
Q. Is it appropriate to reopen a pharmacy after hours to fill a prescription?
A: It depends on who is “reopening” the pharmacy. If the pharmacist comes back and re-opens that is no
problem at all. If it is a tech or an unlicensed person, that is prohibited. A Tech CAN re-enter the pharmacy
136
even if it is closed, but cannot fill a prescription or even dispense a previously filled prescription in the
absence of a pharmacist.
It also depends on the condition of the pharmacist. Was he out drinking? Did he have one drink before he
was called to re-open the pharmacy? If so, the best answer would be that the pharmacist cannot re-enter the
pharmacy to refill the prescription.
Q. If a product such as insulin is frozen then thawed out, it’s adulterated, right?
A: Yes
Q. If a pharmacist consumes any amount of alcohol, can he legally be in the pharmacy and engage in
dispensing?
A: Questions with this type of fact pattern are testing your knowledge of protecting the public. Always err on
the side of saying that even one drink might cause impairment, and chose the option that would protect the
public by making sure the potentially impaired pharmacist is not engaged in the practice of pharmacy.
Q. What law governs the labeling of iron that has been repackaged?
A: The FDA governs labeling, but the Poison Prevention Packaging Act also regulates labeling of iron
containing products.
Q. What are “VIPPS” and “VAWD”?
VIPPS means “verified accredited internet pharmacy provider”, and is a “seal of approval” given to
pharmacies that have an internet presence. The idea is that a pharmacy that appears on-line and has VIPPS
accreditation meets certain standards set by the National Association of Boards of Pharmacy, and can be
trusted.
VAWD means “verified accredited wholesale distributor”, and is a “seal of approval” given to RX drug
wholesale distributors. Again, the idea is that wholesalers that receive this accreditation meet certain
standards set by the National Association of Boards of Pharmacy, and can be trusted. Also, several states (but
not Illinois) include VAWD accreditation as a condition of licensure in their state, or will relax some of the
pre-approval inspection requirements if a wholesaler is VAWD accredited.
Impaired Practitioners
Q. May a doctor who has been treated for addiction, or is presently undergoing treatment for addiction,
prescribe controlled substances?
A. YES, unless the doctor is the subject of a disciplinary order that prohibits it, or has had his state controlled
substance license or DEA registration suspended or revoked.
Q. Can a pharmacist who has been treated for addiction, or is presently undergoing treatment for addiction,
prescribe controlled substances?
A. YES, unless the pharmacist is the subject of a disciplinary order that prohibits it.
Q. What happens when a pharmacist is impaired.
137
A. If a pharmacist is caught working while impaired, that is grounds for discipline. If a pharmacist is addicted
to drugs or alcohol, and has not been caught working while impaired, there are two possible scenarios that
you should be familiar with. First, if the pharmacist voluntarily seeks treatment should contact the Illinois
Impaired Practitioners Health Program (IPHP). If self-help through IPHP is sought, and enrollment in the
recovery program is approved by IPHP, the treatment is maintained in strict confidence. Typically, the
pharmacist is required to enter into a five-year agreement, that includes requirements for periodic, random
drug and/or alcohol screens, regular attendance at recovery meetings (AA or NA), and a referral to a
substance abuse professional for treatment and aftercare. As long as the pharmacist remains fully compliant
with the program, including no positive screening results, the treatment is fully confidential. There is no
discipline, no notice to the employer, and no information shared with IDFPR.
If a pharmacist is caught and determined to be addicted to drugs or alcohol, the Department will refer the
patient to IPHP, but will also enter a disciplinary order against the pharmacist. The discipline will typically
include a suspension for a period of time to be determined based on the facts and circumstances presented,
followed by probation for 3 to 5 years. The typical suspension is 2 years, and the typical probation is 5 years.
The disciplinary order will require all the same things that are required when a pharmacist seeks self-help,
and in addition, the employer will be notified, the employer will be required to provide periodic (usually
quarterly) reports to IDFPR of the pharmacists standing as an employee.
138
SECTION 2
PHARMACY LAW REVIEW
Practice Exam Questions

SECTION TWO
2019 PHARMACY LAW REVIEW

PRACTICE EXAMINATION
1. Which of the following can be ordered using a DEA Form 222? Select all that apply.
A. Pentobarbital capsule.
B. Pentobarbital suppository.
C. Phenobarbital tablet.
D. Marijuana to be used for medical purposes
E. Acetaminophen with Codeine
2. The Consumer Product Safety Commission is responsible for which one of the following?
A. Federal Food Drug, and Cosmetic Act

B. Dietary Supplement Health Education Act
C. Prescription drug to OTC status
D. Poison Prevention Packaging Act
E. Good Manufacturing Practices
3. Place the following in numerical order from smallest to largest. (ALL options must be used.)
Left-click the mouse to highlight, drag, and order the answer options.
1. The number of CE credits required to renew

the registration of a certified pharmacy technician
2. The number of CE credits required to renew
the registration of a pharmacist upon initial renewal
3. The minimum number of hours a pharmacist in charge
is required to work at each pharmacy where he is PIC
4. The number of years that a DEA form 41 must be retained
5. The number of lines on a DEA 222 form
4. Unless the pharmacies share a real-time, on-line prescription database, which of the following prescriptions
may be transferred on only a one-time only basis for the purpose of refill dispensing? Select all that apply.
A. Lomotil tablets
B. Soma
C. Tylenol w/codeine capsules
D. Humira
E. Lorazepam capsules
5. In your jurisdiction, which of the following can be electronically transferred from one pharmacy to another
pharmacy that shares a common prescription database for original, first fill purposes? Select all that apply.
A. Lorazepam
B. Augmentin
C. Dilaudid
D. Levothroid
E. Claritan D
6. The day shift pharmacist at XYZ Pharmacy comes to work and discovers that the night shift pharmacist
borrowed a bottle of 100 Oxycontin 20 mg. tablets from ABC Pharmacy across the street. Later that day, XYZ’s order
arrives from the wholesaler, containing three bottles of 100 tablets of Oxycontin 20 mg. The day shift pharmacist
wants to replace the Oxycontin that was borrowed from ABC. What should the pharmacist do?
A. He cannot return the Oxycontin, because it is illegal to borrow narcotics from another store.
1
© 2019 Edward D. Rickert, All Rights Reserved
DO NOT COPY OR DISSEMINATE WITHOUT AUTHOR’S EXPRESS WRITTEN PERMISSION
B. He can return the Oxycontin, and must complete a DEA 222 order form, and send the form to ABC.
ABC should then retain Copy 3, send copy 2 to DEA, and return Copy 1 to XYZ after it receives the
Oxycontin.
C. He can return the Oxycontin, and must complete a DEA 222 order form, and send Copy 1 and
Copy 2 to ABC with the Oxycontin, and maintain Copy 3 at his pharmacy.
D. He should have ABC prepare a DEA 222 order form, and send copies 1 and 2 to XYZ. XYZ should
then send the Oxycontin to ABC, retain copy 1, and send copy 2 of the 222 form to DEA.
E. He does not have to complete a DEA 222 order form for this transaction, since the Oxycontin was
borrowed, not purchased.
7. A new drug product is given the name “felorazepam" will be marketed to treat insomnia. It is most likely to be
classified as:
A. Schedule II
B. Schedule III
C. Schedule IV
D. ScheduleV
E. Noncontrolled
8. Which of the following statements regarding controlled substances registration under federal law is correct?
Select all that apply.
A. Narcotic treatment facilities are required to have a federal DEA controlled substance registration.
B. A pharmacy that participates in joint buying activities and is the pharmacy that orders, receives and
sends the controlled substances to the rest of the group must register as a distributor of controlled
substances.
C. Hospital pharmacies are required to obtain a DEA registration separate from the hospital’s DEA
number.
D. Pharmacists are permitted to dispense under the pharmacy’s DEA number, and do not need to
obtain a separate registration.
E. Advanced Practice Registered Nurses with full practice authority are permitted to prescribe fentanyl
patches without any physician oversight.
9. Sarah Summers is a 16 year old cashier at the pharmacy. Sarah typically works in the sewing notions
section of the store, but on a busy Saturday morning, is called to work behind the pharmacy counter. Which of the
following is Sarah legally permitted to do while working in the pharmacy? Select all that apply.
A. Ring up sales of prescription and non-prescription medications.

B. Answer customer questions about vitamins that can be purchased over the counter.
C. Obtain prior authorization from Illinois Medicaid to dispense a drug that would not otherwise be covered
by Medicaid.
D. Order non-prescription drug items and sundries from a wholesaler licensed under the Illinois Drug
Wholesaler Act.
E. Take a refill request and prescription number from a customer over the telephone, provided that she
does not enter the number into the pharmacy computer.
10. How can a physician obtain cocaine HCI powder for use as a local anesthetic in his office?
A. He may write a prescription for the drug and write "for office use" on its face.
B. He may write an order for the drug in an institutional setting and label it "for office use".
C. He may order it directly from a supplier using DEA Form 222.
D. He can write a prescription for a patient, use the amount required for the treatment, and keep the remainder
as office stock.
E. He cannot order cocaine HCl powder for office use.
11. A prescription for methadone is issued for the purpose of managing a patient's narcotic addiction by a
physician employed by a narcotic treatment facility. The prescription:
A. May be filled in most community pharmacies with no other requirements.

B. May be filled only in outpatient institutional pharmacies.
C. May be filled in a community pharmacy only if labeled “for detoxification”.
2
D. May only be filled in a community pharmacy if the prescriber is certified to treat addictions on an
outpatient basis and provides a proper DEA registration to confirm that.
E. May not be filled in a community pharmacy
12. A patient presents a prescription for sixty Vicoprofen to his local pharmacy and indicates that he would only
like to get 30 of the tablets now because he cannot afford to pay for 60 tablets. He said he will return for the other 30
in a week if the medication agrees with him. The pharmacy has 100 tablets in stock. The pharmacist is permitted to:
A. Dispense 30 only after calling the prescriber to get permission.

B. Dispense 30 tablets as requested by the patient, but require a new prescription before dispensing
any more Vicoprofen to the patient.
C. Advise the patient that the full 60 tablets must be supplied at one time.
D. Fill the prescription as requested by the patient but advise the patient that the balance must be
FILLED up within 72 hours.
E. Dispense 60 tablets of Vicoprofen.
13. Which of the following is/are true regarding the sale of codeine-containing schedule V cough medicine
without a prescription in your jurisdiction? Select all that apply.
A. Only a pharmacist may dispense the product to the consumer.

B. A non-pharmacist may "ring-up" the sale and collect payment for the product.
C. Not more than 120 mL or 24 dosage units of this product may be sold to the same purchaser in any 48 hour
period.
D. The patient must be 18 years old in order to obtain the medication in this manner.
E. It is not permitted.
A. I only
B. II only
C. I, II & III only
D. I & II only
E. All of the above.
14. How many total continuing pharmacy education hours are required to be completed upon the second
renewal of a pharmacist’s license in this jurisdiction?
A. 15
B. 20
C. 25
D. 30
E. 40
15. Which of the following sublingual tablets do NOT have to be dispensed in child-resistant containers? Select
all that apply.
A. Nitroglycerin
B. Cholestyramine powder
C Isordil sublingual tablets
D. Ventolin inhaler
E. Amoxicillin suspension
16. Which of the following entities is required to register with FDA? Select all that apply.
A. Retail Pharmacies that repackage drugs.

B. Drug manufacturers that make only non-prescription drugs.
C. Compounding pharmacies that operate in compliance with state law.
D. Retail pharmacies that only dispense.
E. 503B Outsourcing Facilities.
3
17. A newly hired pharmacist has received a “Power of Attorney” authorizing her to order schedule II controlled
substances. What is required in order for the “Power of Attorney” to be effective in authorizing a new pharmacist to
sign form 222? Select all that apply.
A. The owner of the pharmacy or an officer if the pharmacy is a corporation must sign the POA.
B. The person who signed the most recent application for DEA registration of the pharmacy must sign
the POA.
C. The pharmacist in charge at the pharmacy must sign the POA.
D. The POA must be submitted to the local DEA filed office.
E. The POA must be signed on the official DEA POA form.
18. Which of the following can be given Power of Attorney to order schedule II controlled substances in your
jurisdiction? Select all that apply.
A. The PIC.
B. A staff pharmacist who is not the PIC.
C. A student pharmacist.
D. A pharmacy technician.
E. A district manager who is not a pharmacist.
19. A patient presents a prescription for Xanax 0.25 mg tablets, quantity 30 with five refills to his local pharmacy.
He tells the pharmacist that he will be traveling abroad for vacation, and would like to obtain 60 tablets so that he
does not run out of medication while he is away. The pharmacist:
A. Must call the doctor to get permission in order to dispense 60 tablets.

B. Is permitted to dispense 60 without calling the doctor if he believes in his professional judgment it is
okay to do so.
C. If not sure what to do, may tell the patient to go to another pharmacy.
D. Dispense 60 tablets, but charge for only 30 and alter the records to reflect that only 30 were
dispensed in order to avoid regulatory scrutiny.
E. B and C are both acceptable responses.
20. A patient presents a prescription for oral contraceptives to a pharmacist. The pharmacist, a devout Catholic,
has reservations about dispensing the medication because of his deeply held moral and religious beliefs. The
pharmacy where the pharmacist works should:
A. Remind the pharmacist that he has the legal obligation to dispense lawfully prescribed prescription
medications and therefore must dispense the medication.
B. Allow the pharmacist to refuse, but make arrangements for the prescription to be filled and
dispensed at the pharmacy.
C. Allow the pharmacist to transfer the prescription to another pharmacy.
D. Do nothing because it is left to the professional judgment of the pharmacist to decide whether or
not to fill a prescription.
21. Who can give a pharmacist permission to not use a child-resistant closure for all prescriptions filled or to be
filled at the pharmacy in the future? Select all that apply.
A. The pharmacist.
B. The prescriber.
C. The patient.
D. The patient's legal guardian.
E. The director of a long term care facility for patients residing in the facility.
4
22. What clinical trial phase consists of post-market surveillance of a drug that was recently introduced onto
market?
A. Phase I
B. Phase II
C. Phase III
D. Phase IV
E. Phase V
23. A prescription for Tussionex Suspension, 180 mL, take 1 or 2 teaspoonfuls every 4 hours for cough is issued
on May 1, 2019, and presented to the pharmacy for filling on May 5, 2019. Assuming that the doctor has authorized
the maximum number of refills, what is the latest date on which the prescription can be refilled?
A. November 5, 2019.
B. April 30, 2019.
C. This prescription cannot be refilled.
D. May 1, 2019.
E. November 1, 2019.
24. A drug product consisting of tablets may be declared adulterated for all of the following reasons EXCEPT:
A. Active drug has undergone partial decomposition.

B. Contains an unapproved color additive.
C. Label does not indicate number of tablets present.
D. Inactive ingredient has undergone partial decomposition.
E. Manufactured in a plant that fails to meet GMP’s.
25. Which of the following is most likely to be a valid DEA registration number for Sheila Smith, an advance
practice nurse employed at an Illinois oncology clinic?
A. AJ 7476218.
B. MJ 7476218.
C. AS 7476213.
D. MS 7476213.
E. BS 7476217.
26. When a pharmacist conducts a controlled substance inventory, which of the following must be included?
Select all that apply.
A. Controlled substances stored in the pharmacy, but not yet placed on the pharmacy shelves.
B. Controlled substances ordered by a patient, filled, and placed in the “will call” area in the pharmacy to be
picked up.
C. Controlled substances set aside for return to the manufacturer, wholesaler or reverse distributor.
D. Pseudoephedrine tablets.
E. Controlled substances that have become adulterated, and have been set aside awaiting destruction.
27. On November 23, 2019, Sid Stoner comes into your pharmacy to refill his prescription for Xanax. The
original prescription was written as follows: Xanax 0.25 mg, quantity 90, one to two tablets every 4-6 hours as needed
for anxiety, with 5 refills. The original date of the prescription was May 25, 2019. The prescription is written by a
physician whom you know as a psychiatrist who is also a member of the state board of medicine. Mr. Stoner’s profile
reveals a diagnosis of anxiety and panic disorders, and the following fill history:
May 30, 2019 – 90 tablets

July 15, 2019 – 15 tablets
July 20, 2019 – 15 tablets
August 1, 2019 – 15 tablets
August 5, 2019 – 90 tablets
October 31, 2019 – 90 tablets
5
He is now seeking a refill of 90 tablets. Which of the following is the best answer?
A. You cannot in good faith refill the prescription.

B. You cannot refill the prescription because he has exceeded the number of refills.
C. To refill the prescription you are required to document the situation and report it to the DEA.
D. You can in good faith dispense 90 tablets as requested.
28. Which of the following agencies is responsible for licensing pharmacists in the state of Illinois?
A. The Illinois Board of Pharmacy.

B. The Illinois Department of Health Professionals.
C. The Illinois Department of Financial and Professional Regulation.
D. The Illinois Department of Public Health.
E. The Illinois Department of Justice.
29. An physician in your jurisdiction enters into an agreement with a pharmacist in your jurisdiction, allowing the
pharmacist to initiate appropriate antibiotic therapy to his patients, based on the pharmacist’s review and analysis of
culture and sensitivity reports that the doctor has ordered. Which of the following statements is correct concerning
this arrangement? Select all that apply.
A. The prescription label for the antibiotic dispensed must include the last name of the physician.
B. The prescription label for the antibiotic dispensed must include at least the initials of the pharmacist
who dispensed the medication.
C. The prescription label must include the name of the antibiotic.
D. The prescription label must include an “expiration date”.
E. The prescription label must include the prescription number.
30. A pharmacist makes a dispensing error. The doctor prescribed "Levothyroxine 0.25 mg.", but the
pharmacist dispended "Lanoxin 0.25 mg." As a result, the drug dispensed from the pharmacy was (select all that
apply):
A. Adulterated.
B. Misbranded.
C. Dispensed in violation of the Illinois Pharmacy Practice Act.
D. Dispensed in violation of the Durham Humphrey Amendments to the Food, Drug and Cosmetics
Act.
E. Required to be quarantined.
31. Which of the following are required before the state will issue a pharmacy license to a new pharmacy?
A. A statement confirming that the pharmacy will open within 30 days of the issuance of the license.
B. The pharmacy must be in a location which is well lighted and well ventilated, with at least 300
square feet of space.
C. A licensed individual must be identified as the pharmacist-in-charge for the location.
D. A and C.
32. Which of the following statements is accurate regarding the duties and responsibilities of a pharmacist-in-
charge in a community pharmacy? Select all that apply.
A. The pharmacist-in-charge and the pharmacy owner are jointly responsible for the operations of the
pharmacy.
B. If there is a change in the pharmacist-in-charge at a location, the departing pharmacist-in charge must
notify the Department of the change within thirty (30) days of the change.
C. The pharmacist-in-charge is solely responsible for the establishment and maintenance of security
provisions in the pharmacy.
D. The pharmacist-in-charge can be disciplined by the state for violations of the Pharmacy Practice Act
even if he or she was not personally involved in the act or failure to act which gave rise to the violation,
and even if he or she was not present in the pharmacy at the time that the violation occurred.
E. If the pharmacist-in-charge is retiring, he must notify the Department 30 days before his last day of
work.
6
33. Which of the following accurately describes the duties of a pharmacist-in-charge when a pharmacy ceases
operations?
A. Within 10 days, the pharmacist-in-charge must provide the Department with a closing inventory of
controlled substances, along with a statement certifying that all controlled substances have been
destroyed following completion of the inventory.
B. The pharmacist-in-charge must notify the Department of the intended disposition of all prescription
drugs within ten days of cessation of operations.
C. The pharmacist-in-charge must sell off all prescription drugs at auction in accordance with the
Illinois Prescription Drug Auction Act.
D. The pharmacist-in-charge has no duties when a pharmacy ceases operations, since those duties
are assumed by the pharmacy owner.
E. Within 30 days, notify and forward to the Department a copy of the closing inventory of controlled
drugs and a statement concerning intended manner of disposition of all legend drugs and
prescription files.
34. A pharmacist in your jurisdiction had his license placed on inactive status, because he forgot to renew the
license in 2015. It is now May 2019. Assuming he has not served time in the military and has not been in active
pharmacy practice in another state, which of the following best describes steps must he take to obtain re-licensure?
A. Reapply and pay all past due renewal fees.

B. Reapply and pay all past due renewal fees, plus proof of 60 hours of CE.
C. Reapply and pay all past due renewal fees, plus proof of 30 hours of CE.
D. Complete 15 hours of a “refresher” course or 15 hours of CE for each lapsed year, or 400 hours of
clinical practice under the supervision of an Illinois pharmacist, and pay all lapsed renewal fees.
35. A faxed schedule II prescription from the prescriber to a pharmacy is permitted (select all that apply):
A. At any time, as long as it is followed by a written “cover” prescription that is received before any drug is
dispensed.
B. If the patient is a resident of a long term care facility.
C. If the patient is a hospice patient.
D. If the patient is a home infusion patient and the drug is an infusion drug.
E. If there is a bona fide emergency, and the prescriber sends an original written prescription to the pharmacy
within 7 days.
36. On November 1, 2018, a pharmacy received delivery of 5,000 doses of chicken pox vaccine. Assuming
proper training, under which of the following circumstances can a pharmacist administer the vaccine to patients who
come into the pharmacy? Select all that apply.
A. A pharmacist can never administer a vaccine, because that is beyond the scope of practice of a
pharmacist.
B. If the patient is 14 years of age or older, and presents a prescription for the vaccine that authorizes
the pharmacist to administer the vaccine.
C. If the patient is 14 years of age or older, and the pharmacy has a standing order from a doctor that
authorizes the pharmacist to administer the vaccine.
D. If the patient is 9 years of age or older, and presents a prescription for the vaccine that authorizes
the pharmacist to administer the vaccine.
E. Only pursuant to a patient specific prescription.
7
37. Which of the following information is required to appear on the label of a medication prepared for unit dose
dispensing by a hospital pharmacy for inpatient use?
I. The name and strength of the drug.

II. The resident's name.
III. The resident's room and bed number.
IV. Directions for use.
A. I, II and III only.

B. III and IV only.
C. I, III and IV only.
D. All of the above.
E. None of the above.
38. An Illinois licensed physician enters into an agreement with an Illinois licensed pharmacist, allowing the
pharmacist to initiate appropriate antibiotic therapy to his patients, based on the pharmacist’s review and analysis of
culture and sensitivity reports that the doctor has ordered. Which of the following statements is correct concerning
this arrangement?
A. It is prohibited, since a pharmacist has no legal authority to prescribe medications under Illinois law.
B. The agreement can be viewed as a standing order, and therefore the arrangement is permitted as
a form of medication therapy management.
C. It is permitted, but only if the patient provides the pharmacist with a prescription from a doctor who
is licensed to prescribe.
D. It is permitted, but only of the standing order is patient specific.
39. A pharmacist receives the following prescription:
Dr. Holly Daze

123 Main Street
Chicago, IL 60606
(312) 555-5555
William Smith 4/25/2018

1500 Candy Cane Lane, Arlington Heights, IL
Synthroid 2 mg. # 30
One q AM
DISPENSE BRAND ONLY!!!
Substitution Permitted
x Brand Medically Necessary
Refills: 6
Holly Daze, MD
The prescription is handwritten and hand signed by Dr. Daze. The pharmacist consults the federal Orange Book, and
sees that there is just one generic version of levothyroxine listed that has an AB rating, and there are a half dozen
others that are all rated BB. You have both the AB rated and another drug that is listed as BB rated in stock. The BB
rated drug is less expensive, and if dispensed will increase the pharmacy’s profit for that dispense.
You note that the only handwriting on the prescription is that of Dr. Daze. He also notes that the patient is a Medicaid
recipient, and believes that Illinois Medicaid will only pay for generics. Which of the following is correct? Select ALL
that apply.
8
A. Daze has made it clear that she wants the brand name, so the pharmacist must dispense
Synthroid.
B. If the pharmacist confirms that Medicaid will only pay for generics, the pharmacist would be
permitted to dispense any A rated generic you have in stock without calling the Dr. Daze.
C. The pharmacist is permitted to dispense any A rated generic without calling Dr. Daze.
D. If the pharmacist calls Dr. Daze and she agrees to allow him to dispense levothyroxine 2 mg, the
pharmacist can change the prescription and dispense either the A rated or the B rated drug.
40. Which of the following is required if a pharmacy that is owned by a doctor is going out of business? Select
ALL that apply.
A. The PIC or pharmacy owner must notify the Division of Professional Regulation that the pharmacy
will be closing within 30 days after the pharmacy has closed.
B. Customers must be notified of the closure at least 15 days in advance of the closing date and
where the customer's records will be maintained.
C. An inventory of the pharmacy's controlled substances must be performed, and that record must be
maintained for a period of five years.
D. After the closing date, only the owner, the pharmacist-in-charge, or other designated pharmacist is
permitted to have access to the prescription drugs in the pharmacy.
E. Any signage identifying the location as a pharmacy must removed or covered as soon as
practicable, and a sign indicating that the pharmacy is closed must be prominently posted.
F. This is a trick question - none of the above are correct because a doctor cannot own a pharmacy.
41. After the pharmacy closes for the evening, the pharmacist and technician leave the pharmacy to go home.
Before leaving, the last thing the pharmacist does is verify a prescription that was dropped off an hour earlier by Dr.
I.M. Snooty, a prominent ENT who lives in town. The prescription was filled by the technician, checked by the
pharmacist, and placed in a sealed bag in the ‘will call” bin before the pharmacist left for the night. Shortly after the
technician and pharmacist leave, Dr. Snooty arrives at the pharmacy for his medication, and is irate that the
pharmacy has already closed. Which of the following can be done by the store manager (who is neither a pharmacist
nor a technician) to get the doctor the medication he needs?
A. Since delivery to the patient is not “dispensing”, he can enter the pharmacy, retrieve the medication
from the will call bin, and ring up the sale.
B. He can enter the pharmacy, retrieve the medication from the will call bin, and ring up the sale, but
only after calling the pharmacist on his cell phone to get permission to do so.
C. He cannot retrieve the medication for delivery to the doctor under the facts as presented.
D. Since the patient is a doctor, he can supervise the manager as he enters the pharmacy to retrieve
the medication.
42. Which of the following statements is accurate regarding the labeling requirements for over the counter
("OTC") medications which are transferred from a large container provided by the manufacturer, to a smaller
container for sale to the public?
A. This practice is unsafe, and is prohibited under Illinois law.

B. This practice is permitted, provided that the name and quantity of the OTC drug is placed on the
label.
C. This activity is regulated by FDA as drug manufacturing.
D. All of the above.
E. None of the above.
43. In your jurisdiction, which of the following is required in order for a hospital resident who is not yet registered
with DEA to prescribe Fentanyl in the hospital? Select all that apply.
A. The resident must be working under the direct supervision of an attending physician, with the use of the
attending physicians DEA registration number.
B. The resident may prescribe as described provided that the resident is acting within the scope of his
employment and has been assigned a special internal code, consisting of the hospital DEA number and
a unique suffix, consisting of a numbers, letters, or a combination.
C. The resident can prescribe as described in option B, provided that he has passed the national federal
controlled substances prescribing examination.
D. The resident can prescribe as described in option B, but only if the Fentanyl is in an oral, topical or
transdermal dosage form.
9
E. A resident cannot legally prescribe Fentanyl under any circumstance.
44. The use of a remote automated pharmacy system:
I. Can be used only for purposes of dispensing refills.

II. Can be used if there is an audio and video link to a pharmacy, to allow a pharmacist to counsel each
patient each time a medication is dispensed from the device.
III. Can be used in a physician’s office, in which case an audio and video link for counseling by a pharmacist
is not required.
IV. Can be used if there is an audio and video link to a pharmacy, to allow pharmacy personnel at the home
pharmacy to make the offer to counsel the patient occur before medications are released from the device.
A. I.
B. II and III.
C. III and IV.
D. I, II and III.
E. I, III and IV.
45. Which of the following statements regarding “compounding” is correct? Select all that apply.
A. A pharmacy is always required to have a patient specific prescription in hand before compounding.
B. If a compounded product contains no prescription drug ingredients, the pharmacy is permitted to
compound and sell the product “over the counter”, without receiving a prescription drug order or
initiative.
C. Compounding a product which is “commercially available” is never permitted.
D. Compounding for a doctor to administer the drug in his office is permitted, even though the
pharmacist does not know the identity of the patient at the time that he compounds.
E. Compounding a product containing a combination of over-the-counter ingredients in a combination
and in strengths that are not commercially available is permitted if pursuant to a prescription.
46. Sarah submitted an application to become registered as a technician on May 1, 2018. As of July 2, 2018, the
Department had not yet reviewed her application, and has not issued her registration. Sarah reminds the pharmacist
that she just relocated to Illinois, and was a certified technician in the state of Iowa, and still maintains her
certification. In addition, you call IDFPR in Springfield on July 3, and are told that Sarah’s application is the tenth one
from the top of the pile, but since they only process five applications per day, and with the holiday coming, she will not
get her registration issued until after July 6 or 7. However, she says that because of the unique circumstances, Sarah
can continue to work as a technician based on her Iowa certification, and the pending holiday. What can Sarah legally
do in the pharmacy on July 3, 2018? Select all that apply.
A. Count medications and place them in vials for labeling and dispensing.
B. Pour water into a bottle of amoxicillin powder for reconstitution.
C. Ring up a sale of a prescription medication and hand the medication to the patient when the pharmacy
is open and the pharmacist is on duty.
D. Ask customers whether they have questions for the pharmacist.
E. Enter a prescription number into the computer so that pharmacist can process and fill the refill.
F. Place an order over the telephone for diabetes test strips.
G. Review a patient’s insurance benefits with a physician in order to help the patient get prior authorization
for a biologic drug product.
47. Which of the following activities may be performed by a certified technician in Illinois?
A. Contact another pharmacy by telephone to obtain a verbal prescription transfer from that
pharmacy.
B. Counsel a patient, under the direct supervision of the pharmacist.
C. Perform clinical conflict resolution, under the direct supervision of a pharmacist.
D. Fill prescription without on-site pharmacist supervision from a properly licensed remote dispensing
site.
10
48. A prescription for a non-controlled substance is issued on May 1, 2018. The doctor has indicated “prn”
refills, indicating that he is authorizing it to be refilled as often as the patient needs the medication, until the
prescription expires. It is presented to the pharmacy and is filled for the first time on June 16, 2018. Which of the
following statements concerning this prescription is correct?
A. It can be refilled until the end of the day on April 30, 2019.
B. It can be refilled until the end of the day on May 1, 2019.
C. It can be refilled until the end of the day on June 15, 2019.
D. It can be refilled until the end of the day on June 16, 2019.
E. It can be refilled until the end of the day on November 1, 2018.
49. Which of the following is one of the reasons that a pharmacy can lawfully refuse to dispense a lawfully
prescribed prescription medication? Select all that apply:
A. When, in the pharmacist’s professional judgment, drug therapy problems due to therapeutic
duplication may result if the medication is dispensed.
B. When the patient expresses that he has no insurance, and cannot afford the medication.
C. When the patient appears to be a member of a street gang, and the drug prescribed is a narcotic.
D. When the pharmacy lacks the specialized equipment needed to compound a particular drug.
E. When the prescription appears to be fraudulent.
50. Which of the following is true regarding physician assistant (PA) prescriptive authority?
A. A delegation of prescriptive authority from a physician must be filed with the Division of Professional
Regulation.
B. If a PA is prescribing a controlled substance, the delegating physician’s DEA number can be used.
C. If the PA is located out of state, no delegation of prescriptive authority is required if the state where
the PA is located does not require a delegation.
D. If prescribing a schedule II controlled substance, the delegation must indicate, by drug class, the
type of schedule II the PA is authorized be prescribe.
E. The prescriptions issued by the PA must be periodically reviewed by the delegating physician.
51. Betty White, an elderly patient who has been coming to you pharmacy for many years, comes in one Sunday
evening just prior to closing, and asks for a refill of her digoxin. You note that there are no refills remaining. The last
RX on file was for digoxin 0.125 mg, 1 AM, quantity 30, with 6 refills. You note that prior to that, she had been
receiving the same medication in the same strength and directions for use, but from a different doctor, for over 2
years. Which of the following is the best answer?
I. The prescription is not refillable, so you should advise Betty to go to the emergency room to receive a new
prescription from the doctor on call.
II. The prescription is not refillable, so you should advise Betty she will be fine skipping the drug for a couple
of days until you can get authorization to refill the drug.
III. You should give her a few tablets to hold her over until you can get a hold of the doctor to obtain a new
prescription.
IV. If you give her a few tablets to hold her over, you will likely not be disciplined for your exercise of
professional judgment.
V. If you give her a few tablets to hold her over, you will likely be disciplined for your lack of good professional
judgment.
A. I.
B. II.
C. III and IV.
D. III and V.
11
52. A nurse practitioner enters into an agreement with an oncologist, which authorizes him to manage the pain
for all of his cancer patients. A pharmacist receives a prescription from this nurse practitioner calling for “Fentanyl
lollipops”, a schedule II narcotic, to treat pain for one of the cancer patients being treated by the supervising
physician. Which of the following is correct?
A. The pharmacist cannot fill the prescription.

B. The pharmacist can fill the prescription if the advanced practice nurse has been delegated CII
prescriptive authority by her supervising physician.
C. The pharmacist can fill the prescription if the nurse practitioner uses the supervising doctor’s DEA
number.
D. The pharmacist can fill the prescription only if the APN has been delegated CII prescriptive
authority, and fentanyl lollipops are identified as one of the CIIs she is authorized to prescribe.
53. Nurse Betty, an Advance Practice Nurse, phones a pharmacy and says that her collaborating physician
would like their patient, Tom Jones, to receive Valium 5 mg., quantity 30, one tablet every 4 to 6 hours for anxiety.
The prescription is:
A. Invalid in all case.

B. Valid only if Nurse Betty has a collaborative practice agreement with Dr. Smith which includes a
delegation of authority that includes schedule IV controlled substances, and when dispensed, the
prescription label for the product will identify Nurse Betty as the prescriber.
C. Valid, only if Nurse Betty follows up with a written prescription countersigned by Dr. Smith with 7
days.
D. Valid only if Nurse Betty has a collaborative practice agreement with Dr. Smith which includes a
delegation of authority that includes schedule IV controlled substances, and when dispensed, and
the prescription label for the product will identify Dr. Smith as the prescriber.
E. The prescription is valid and the prescription label will identify Dr. Smith as the prescriber.
54. Place the following in the order in which they would expire according to federal regulations, starting with the
earliest. (ALL options must be used.)

1. A partially filled dextramethasone prescription
2. A phoned-in, emergency hydrocodone with
APAP prescription
3. A partially filled Dialudid prescription for
a patient not in a long-term care facility
4. An electronic alprazolam prescription
5. A partially filled morphine prescription for a
patient in a long-term care facility
12
ANSWER KEY
1. A, D 27. D
2. D 28. C
3. 2, 4, 3, 5, 1 29. A, B, C, E
4. A, B, C, E 30. B, C, D
5. B, D, E 31. D
6. D 32. A,B, D
7. C 33. E
8. A, B, D 34. C
9. A, B, C, D 35. A, B, C, D, E
10. C 36. B, C
11. E 37. A
12. B 38. B
13. A, B 39. C, D
14. D 40. B, C, E
15. A, B, C, D 41. C
16. A, B, E 42. C
17. B 43. B
18. A, B, C, D, E 44. B
19. B 45. D, E
20. B 46. C, F, G
21. C, D 47. D
22. D 48. A
23. C 49. A, B, D, E
24. C 50. A, E
25. B 51. C
26. A, C, D, E 52. A
53. E
54. 3, 2, 5, 4, 1
13
SECTION 3
PHARMACY LAW REVIEW
Federal Poison Prevention Packaging Act

PART II
Substances Covered by Regulation
Background customarily produced for use in or around the

household. Foods, drugs, cosmetics, as defined
The PPPA gives the Commission the by the Federal Food, Drug and Cosmetic Act,
authority to require special packaging of hazardous substances as defined by the
hazardous household substances to protect Federal Hazardous Substances Act (FHSA),
children. Section 3 of the PPPA details the and pre-packaged fuels are all within the
findings that the Commission must make prior to jurisdiction of the legislation.
promulgating a special packaging standard. The
Commission may require special packaging of a The responsibility for administration and
household substance if it finds that: enforcement of child-resistant packaging for
pesticides (including cleaning products that
The degree or nature of the hazard to make antimicrobial claims) lies entirely with the
children in the availability of such Environmental Protection Agency (EPA) under
substance, by reason of its packaging, the Federal Insecticide, Fungicide, and
is such that special packaging is Rodenticide Act (FIFRA). It should be noted that
required to protect children from the same test methods for determining whether
serious personal injury or serious a package is child-resistant and senior friendly
illness resulting from handling, using, apply to pesticides because the FIFRA was
or ingesting such substance; and amended to recognize packaging and labeling
violations under the PPPA.
The special packaging to be required
by such standard is technically
In the years since enactment of the PPPA,
feasible, practicable, and appropriate
many household chemicals or categories of
for such substance.
household substances have been added to the
In establishing a standard the Commission list of regulated substances21. Those standards
also considers: dealing with drug products, particularly
prescription drug products, will be discussed in
1. the reasonableness of such somewhat greater detail. A list of substances
standard; that require special packaging as of 2005, is
presented below. Please refer to the PPPA
2. available scientific, medical, and
regulations at 16 CFR § 1700.14 for the most
engineering data concerning
current list of regulated substances and for the
special packaging and concerning
specific details of each regulation.
childhood unintentional ingestions,
illness, and injury caused by
Substances Regulated At 16 CFR § 1700.14
household substances;
3. the manufacturing practices of • Aspirin: Any aspirin-containing preparation
industries affected by the PPPA; for human use in oral dosage form.
and
• Furniture Polish: Low-viscosity, non-
4. the nature and use of the
emulsion type liquid furniture polish
household substance.
containing 10 percent or more petroleum
The scope of products, which may distillates, unless packaged in pressurized
potentially be subject to special packaging spray containers. (These products also
standards is quite broad and includes products require restricted flow so that not more than
5
2 milliliters is obtained when the package is • Ethylene Glycol: Household substances in
inverted, squeezed or otherwise activated liquid form containing 10 percent or more by
once.) weight of ethylene glycol.
• Methyl Salicylate (oil of wintergreen): Liquid • Iron-Containing Drugs: Non-injectable

preparations containing more than 5 percent animal and human drugs providing iron for
by weight, unless packaged in pressurized therapeutic or prophylactic purposes which
spray containers. contain a total amount of elemental iron
equivalent to 250 milligrams or more per
• Controlled Drugs: Preparations intended for package.
oral human use, which are subject to the
Comprehensive Drug Abuse Prevention and • Iron-Containing Dietary Supplements: Most
Control Act of 1970. dietary supplements that contain an
equivalent of 250 milligrams or more of
• Sodium and/or Potassium Hydroxide: elemental iron per package.
Household substances in dry form
(granules, powders, flakes, etc.) containing • Solvents for Paint or Similar Surface
10 percent or more by weight and all other Coatings: Prepackaged low-viscosity liquid
household substances (aerosols, liquids, solvents for paints or other surface-coating
pastes) containing 2 percent or more by material that contain 10 percent or more by
weight, of chemically unneutralized sodium weight of benzene, toluene, xylene,
and/or potassium hydroxide. petroleum distillates, or any combination
thereof.
• Turpentine: Household substances in liquid
form containing 10 percent or more by • Acetaminophen: Preparations for human
weight of turpentine. use in oral dosage forms containing more
than 1 gram of acetaminophen in a single
• Kindling and/or Illuminating Preparations: package.
Prepackaged low viscosity substances (i.e.,
cigarette lighter fluids, charcoal lighter fluids, • Diphenhydramine: Preparations for human
camping equipment fuel, torch fuel, and fuel use in oral dosage forms containing more
for decorative or functional lanterns) which than the equivalent of 66 milligrams of
contain 10 percent or more by weight of diphenhydramine base in a single package.
petroleum distillates.
• Glue removers containing acetonitrile:
• Methyl Alcohol (Methanol): Household Household glue removers in a liquid form
substances in liquid form containing 4 containing more than 500 milligrams of
percent or more by weight of methyl alcohol, acetonitrile in a single container.
unless packaged in a pressurized container.
• Permanent wave neutralizers: Liquid home
• Sulfuric Acid: Household substances permanent wave neutralizers, containing
containing 10 percent or more by weight of more than 600 milligrams of sodium
sulfuric acid, except in wet cell storage bromate or more than 50 milligrams of
batteries. potassium bromate in a single container.
• Prescription Drugs: Any drug for human use • Ibuprofen: Preparations for human use in
in oral dosage form and which is required by oral dosage forms containing 1 gram or
federal law to be dispensed only by or upon more of ibuprofen in a single package.
an oral or written prescription of a
practitioner licensed to administer such • Loperamide: Preparations for human use in
drug. oral dosage forms containing more than
6
0.045 milligrams of loperamide in a single Review of the list of categories reveals a
package. wide range of household products and
chemicals. Healthcare professionals are more
• Mouthwash: Most mouthwash containing 3 directly involved with those regulations dealing
grams or more of ethanol in a single with drug products than household chemical
package. products.
• Lidocaine: Products containing more than 5 Aspirin and Acetaminophen

milligrams of lidocaine in a single package.
Aspirin was the first substance to be
• Dibucaine: Products containing more than regulated under the PPPA. Note that while
0.5 milligrams of dibucaine in a single acetaminophen is regulated at a level of more
package. than 1 gram per package, no level has been
established for aspirin and aspirin-containing
• Naproxen: Preparations for human use in products. Thus a substance containing any
oral dosage forms containing 250 milligrams amount of aspirin is required to be in special
or more of naproxen in a single package. packaging. There are two exemptions to each of
these regulations; each based primarily upon
• Ketoprofen: Preparations for human use in physical characteristics of the dosage forms,
oral dosage forms containing more than 50 which have been found to inhibit or limit
milligrams of ketoprofen in a single package. unintentional ingestion of these products by
children. These exemptions are:
• Fluoride: Products containing more than 50
milligrams of elemental fluoride and more 1. Effervescent tablets or granules containing
than 0.5 percent fluoride in a single not more than 15 percent acetaminophen or
package. aspirin, provided the dry tablet or granules
have an oral LD50 of 5 grams or more per
• Minoxidil: Preparations for human use kilogram of body weight.
containing more than 14 milligrams of
minoxidil in a single package. 2. Unflavored acetaminophen or aspirin-
containing preparations in powder form
• Methacrylic Acid: Liquid products containing (other than those intended for pediatric use)
more than 5 percent (weight to volume) that are packaged in unit doses providing
methacrylic acid in a single package. not more than 13 grains of acetaminophen
or 15.4 grains of aspirin per unit dose.
• Over-the-Counter Drug Products:
Preparations in oral dosage forms that Methyl Salicylate
contain any active ingredient that was
previously available for oral administration This regulation covers liquid preparations
only by prescription. containing more than 5 percent by weight of the
substance and specifically exempts pressurized
• Hazardous substances containing low- spray containers. The cream and ointment
viscosity hydrocarbons: Products containing preparations are not included.
10 percent or more hydrocarbon by weight
with a viscosity of less than 100 SUS at Controlled Drugs
100ºF.
All controlled drugs intended for oral
• Drugs and cosmetics containing low administration to humans are covered without
viscosity hydrocarbons: Products containing exception, including over-the-counter
10 percent or more hydrocarbon by weight preparations.
with a viscosity of less than 100 SUS at
100ºF.
7
Iron-Containing Drugs and Dietary government choose to require all human oral
Supplements prescription drugs to be dispensed in special
packaging?
Iron-containing drugs and dietary
supplements that contain 250 mg or more The answer is twofold. First, it provides the
elemental iron have required special packaging best protection of children. Second, it eliminates
since 1978. Iron was responsible for many the formidable task for dispensing pharmacists
poisoning deaths. Consumers may be unaware of having to maintain complete and accurate
of the toxicity of iron. It is important for listings of regulated and non-regulated drugs.
Healthcare Professionals to educate their Since new drugs and drug classes are being
patients about the toxicity of iron. approved by the FDA at an increased rate,
promulgation of separate regulations for drugs
Lidocaine, Dibucaine, and Minoxidil or classes of drugs known to be a potential
hazard to young children upon unintentional
All three of these drugs are available in ingestion would have been an extremely
topical formulations. The regulations for onerous task. In addition, the burden upon
lidocaine and dibucaine, two topical local individual pharmacists would have been great
anesthetic drugs, are noteworthy because they since they would have to check each drug,
extend to all dosage forms including creams, dosage strength, and amount before dispensing.
sprays, and transdermal patches. Minoxidil is These problems were resolved by regulating all
available as an oral prescription drug used for human oral prescription drugs and then
hypertension; this formulation requires special establishing a procedure for exempting products
packaging under the prescription drug rule. that do not pose a hazard to children (described
Minoxidil is also available in topical form for hair below). This approach was possible with the
regrowth. The CPSC regulated minoxidil to support and cooperation of the various
require the topical forms to be sold in special pharmaceutical, trade, and professional
packaging. Many minoxidil preparations are sold associations.
with applicators (i.e., droppers or spray pumps)
that are intended to replace the original closure Oral investigational drugs for outpatient
on the package of minoxidil. The package is clinical trials require special packaging under the
required to comply with the special packaging Human Oral Prescription Drug Rule. Because of
requirements of the PPPA for the life of the the special circumstances surrounding the use
product. Thus the package must continue to of investigational drugs, the CPSC staff has
meet the special packaging requirements when issued guidance on the packaging of these
the provided applicators are affixed to the products.23
package.22
Oral prescription drug samples and “starter
Human Oral Prescription Drugs kits” dispensed by the prescribing practitioners
require special packaging. However, the current
The special packaging requirement for oral CPSC position is that manufacturers are not
prescription drugs, which became effective on responsible for the special packaging of these
April 16, 1974, has had great impact on both products since they are distributed by a licensed
pharmacists and drug manufacturers. As medical practitioner who has the authority to
described previously, the PPPA requires that a specify non-complying packaging for his/her
number of findings be made before a special patients. This is not the case for oral prescription
packaging standard can be promulgated. The drugs, including samples, that are dispensed by
key finding is the establishment that the pharmacists, since pharmacists do not have the
substance, because of the way it is packaged, authority to specify that prescriptions be
has a significant potential for causing serious dispensed in non-complying packaging.24
personal injury or illness in children. However,
some human oral prescription drugs may not
have the potential to cause serious injury or
illness to children. Why then did the Federal
8
Drugs Switched from Rx to OTC Status single size that does not comply with such
standard if:
Diphenhydramine, ibuprofen, loperamide,
naproxen, and ketoprofen are drugs that were 1. The manufacturer (or packager) also
originally available by prescription. The FDA supplies such substance in packages that
allowed the over-the-counter (OTC) sale of comply with such standard; and
certain formulations of these drugs. When these
drugs were granted OTC status, they were no 2. The packages of such substance that do not
longer required to be packaged in special meet such standard bear conspicuous
packaging under the oral prescription drug rule. labeling stating: "This package for
The CPSC had to initiate separate rulemaking households without young children"; (or
activity in order to require special packaging of “Package Not Child-Resistant” for small
each drug. In 2001, the CPSC issued a rule to packages).
require special packaging of oral prescription
drugs that are granted over-the-counter (OTC) As a result, manufacturers of over-the-
status by the FDA. This will ensure that special counter household products regulated under the
packaging will continue to be required for these PPPA, have the option of marketing one size in
products when they are more readily available to a conventional package as long as that same
the public. Separate rulemakings such as those product is supplied in popular-sized complying
for diphenhydramine, ibuprofen, loperamide, packages. There is one exception. Under the
naproxen, and ketoprofen will be unnecessary in Federal Hazardous Substances Act, household
the future for these types of drugs. products containing more than 10 percent
sodium/potassium hydroxide are banned unless
Exceptions and Exemptions marketed in special packaging.26 The effect of
this is to essentially remove the option of
The section above describes the producing a single non-complying package of
substances that must be in special packaging. the substance.
However, there are several situations when
special packaging is not required. Since the Section 4(b) of the PPPA addresses the
PPPA applies only to substances used in or need for facilitating access to prescription drugs
around the household, the special packaging by elderly and handicapped individuals who
requirements do not extend to products used in have difficulty using special packaging.27
institutional settings such as hospitals and
traditional nursing homes. However, if the "In the case of a household substance
patients are taking the drugs home, including which is subject to such a [PPPA]
assisted-living types of homes where patients standard and which is dispensed
are responsible for taking their medication, the pursuant to an order of a physician,
substances need to be in special packaging. dentist, or other licensed medical
practitioner authorized to prescribe,
Congress had concerns about the ability of such substance may be dispensed in
elderly or handicapped individuals to access noncomplying packages only when
products in special packaging. Therefore, the directed in such order or when
PPPA contains provisions to facilitate access of requested by the purchaser.”
products by these special populations. Section
The pharmacist's role in implementing this
4(a) of the PPPA provides for the marketing of
section is further discussed in Chapter III.
"non-complying" or non-special packages of
regulated substances other than prescription
In addition to the scenarios described
drugs in order to facilitate access to regulated
above, the regulations of the PPPA contain a
products by the elderly and handicapped.25
procedure whereby exemptions from special
packaging requirements may be granted by the
A manufacturer or packager may package
Commission. An exemption request, in the form
any over-the-counter household substance
of a formal petition, is generally initiated by the
(subject to a PPPA standard) in packaging of a
9
manufacturer of a product. The majority of such than 264 milligrams of sodium fluoride per
requests are from manufacturers of human oral package.
prescription drugs. Generally such requests
seek exemption for a specific package size of a 8. Betamethasone tablets packaged in
drug, normally a package designed for direct manufacturers' dispenser packages
dispensing to the consumer after appropriate containing no more than 12.6 milligrams
labeling by the pharmacist. betamethasone.
The petitioner must submit various data 9. Mebendazole in tablet form in packages
relating to the toxicity of the product, and, containing not more than 600 milligrams of
generally must establish that the amount of the drug.
product contained within the requested
exemption would not be harmful to a child under 10. Methylprednisolone in tablet form in
5 years of age. Formal exemption criteria exist packages containing not more than 84
to guide manufacturers in submitting petitions.28 milligrams of the drug.
The exemption procedure involves rulemaking
by the Commission. 11. Colestipol in powder form in packages
containing not more than 5 grams of the
As of 2005, the following prescription drugs drug.
are exempt from the PPPA standards and may
be dispensed in conventional packaging, as long 12. Pancrelipase preparations in tablet, capsule,
as they contain no other substance subject to 16 or powder form.
CFR § 1700.14(a).29 The specific exemptions
are in the PPPA regulations at 16 CFR § 1700 13. Cyclically administered oral contraceptives
(a)(10). in mnemonic (memory-aid) dispenser
packages which rely solely upon the activity
1. Sublingual dosage forms of nitroglycerin, of one or more progestogen or estrogen
substances.
2. Sublingual and chewable forms of
isosorbide dinitrate in dosage strengths of 14. Prednisone in tablet form when dispensed in
10 milligrams or less. packages containing no more than 105
milligrams of the drug.
3. Erythromycin ethylsuccinate granules for
oral suspension and oral suspensions in 15. Conjugated estrogen tablets when
packages containing not more than 8 grams dispensed in mnemonic dispenser packages
or the equivalent of erythromycin. containing not more than 32.0 milligrams of
the drug.
4. Erythromycin ethylsuccinate tablets in
packages containing no more than the 16. Norethindrone acetate tablets in mnemonic
equivalent of 16 grams erythromycin. dispenser packages containing not more
than 50 milligrams of the drug.
5. Anhydrous cholestyramine in powder form.
17. Medroxyprogesterone acetate tablets.
6. Potassium supplements in unit dose forms,
including individually wrapped effervescent 18. Sacrosidase (sucrase) preparations in a
tablets, unit dose vials of liquid potassium, solution of glycerol and water.
and powdered potassium in unit dose
packets, containing not more than 50 19. Hormone Replacement Therapy products
milliequivalents per unit dose. that rely solely upon the activity of one or
more progestogen or estrogen substances.
7. Sodium fluoride drug preparations, including
liquid and tablet forms, containing no more
10
CHAPTER III
Responsibilities Under the Act – Frequently Asked Questions
Prescribers/Dispensers of Medications pharmacist make this decision without the

customer's specific request?
Q. What is the responsibility of the pharmacist
under the PPPA? A. No. The pharmacist may advise the
customer that he/she has the option of
A. The pharmacist must dispense oral having the prescription dispensed in
prescription drugs in special packaging noncomplying packaging, but the choice
unless the drug is exempted or the patient must be that of the customer.
or prescribing practitioner requests non-
special packaging. Q. Must the customer make the choice for
conventional packaging in writing?
Q. May an individual request that all of his/her
prescriptions be filled in conventional (non- A. Although many pharmacists do require a
special) packaging? written waiver, the law and regulations do
not require a written request. The CPSC
A. Yes, the law does not preclude a staff recommends, however, that the
pharmacist from relying upon a specific pharmacist get a request in writing
request from a patient to have all of his/her particularly when a blanket waiver is being
medications placed in non-special requested. This will assist the pharmacist
packaging. Many pharmacies choose to during inspections of the pharmacy by
have this request in writing, i.e., a blanket regulatory agencies.
waiver. However, a single request from a
patient to dispense a specific prescription in Q. May a pharmacist dispense a prescription
non-special packaging is not a basis for the drug in a noncomplying package in
pharmacist to infer the patient wants all response to a standing order from a
subsequent prescriptions to be dispensed physician that it be so dispensed?
in non-special packaging. Such a request is
not a blanket waiver. A. This can be done only when it applies to
refills of a prescription where the physician
A patient who previously requested blanket has prescribed noncomplying packaging for
non-special packaging may later change that prescription. However, a drug
his/her mind about the use of such dispensed to the same person on a
packaging because of changing personal different prescription of the same or another
circumstances, but may not remember to prescriber must be dispensed in special
inform the pharmacist of the change in packaging, unless the prescription directs
packaging preference. It is a prudent the use of noncomplying packaging or the
practice for the dispensing pharmacist to purchaser requests it.
periodically check with all patients who
have blanket waiver requests on file to Q. Can a physician simply check a box on a
ensure that noncomplying packaging prescription blank to indicate to the
continues to be the preferred packaging pharmacist that a drug be dispensed in
choice for the patients' prescription drugs. noncomplying packaging?
Q. If the pharmacist is aware that one of A. Yes. However, the CPSC staff discourages
his/her customers prefers conventional the use by physicians of prescription blanks
packaging for his/her prescriptions, can the having a box to check for noncomplying
11
packaging, on the basis that the practice A. As a general rule, no. This prohibition is
would tend to encourage excessive use of based on the wear associated with a plastic
noncomplying packaging. vial, which could compromise the
package’s effectiveness. Since such wear
Q. Who is responsible for determining at the or undetected damage with a glass
retail level whether a prescription drug must container is negligible, the CPSC staff has
be packaged in accordance with PPPA indicated that it would have no objection to
standards? the reuse of a glass container, provided a
new closure is used. This same
A. It is the responsibility of the dispensing consideration would be given to any other
pharmacist. Unless a prescription drug is package type that is not prone to wear.
expressly exempted from the regulations,
or the customer or prescribing physician Q. Does the regulatory reference to “dosage
request noncomplying packaging, the drug forms intended for oral administration”
must be dispensed in a special package. include drugs intended for topical
application to the teeth or mouth, or in a
Q. How does a pharmacist or physician dosage form intended for inhalation?
become aware of which drugs are
exempted from PPPA standards? A. No. The regulations intend “oral
administration” to pertain to drugs that are
A. This information listed in the PPPA taken by mouth for a systemic and not local
regulations at 16 CFR § 1700.14 and is effect. Sublingual preparations are
available on the CPSC website, considered “orally administered” even
http://www.cpsc.gov/businfo/notices.html though they are not swallowed. Their effect
Announcements are published in the is systemic and not local to the mouth.
Federal Register, and in news releases Because of the need for quick access to
issued by CPSC (which may be published the drug, sublingual nitroglycerin was
in the local press). In addition, the journals excluded from the oral prescription drug
and newsletters of pharmaceutical and regulation when it was adopted in 1973.30
medical groups, as well as the trade press,
publicize these exemptions. Q. When a prescription drug is dispensed in a
special package, would the pharmacist be
Q. In the case of an antibiotic drug provided by in violation of the regulations if he or she
the manufacturer in a granular form to be included a separate non-complying closure
reconstituted by the pharmacist, who is with the package?
responsible for providing the special
package the pharmacist or the A. Although this practice is not prohibited, the
manufacturer? CPSC staff discourages the practice in that
it is likely to result in the use of
A. If the product is in the same container noncomplying packaging by those who are
intended to be given to the purchaser, the able to use special packaging without
manufacturer and the pharmacist are both difficulty.
responsible.
Q. Are Investigational New Drugs (INDs)
Q. Does the same rule apply to drugs subject to the PPPA standards?
dispensed in dropper bottles?
A. Yes. Oral INDs are subject to the oral
A. Yes. prescription drug regulation, if the IND is a
drug that is for oral administration to
Q. In the case of refills, can prescription humans, can be dispensed only on or by an
bottles and vials be reused? order of a licensed medical practitioner,
and is to be dispensed directly to the
12
patient. Such drugs must be packaged in a A. No, provided they are to be used for
special package except as described at institutionalized patients. The test is
http://www.cpsc.gov/BUSINFO/trials.pdf. In whether the package is likely to enter a
addition, if INDs contain any substances home.
regulated under any of the other PPPA
regulations, they would be required to be Q. My pharmacy provides drugs to a nursing
packaged in special packaging if they are home. Must these drugs be dispensed in
dispensed for household use. special packaging?
Q. May a pharmacist legally use reversible or A. No, traditional nursing homes where the
other types of dual-purpose packaging for nursing home staff administers doses to
dispensing prescription drugs? residents are considered to be institutions.
This would not be true of senior citizen
A. Although this type of packaging is not apartment complexes or assisted living
prohibited, the CPSC staff discourages its facilities where residents store their drugs
use because it is likely to result in the use in their households. The test is whether the
of non-special packaging. The potential for package is likely to enter a home.
children being poisoned thus increases.
Q. I know of several physicians who dispense
Q. What should I advise a consumer who calls prescription drugs for a fee. Are they
for information when there is a suspected subject to the provisions of the PPPA?
poisoning or childhood ingestion
emergency? A. Yes. Physicians who dispense drugs
(including drug samples), are, and always
A. If you are unable to provide the necessary have been, subject to the regulations under
emergency information for the caller or the PPPA. It is important to note, however,
advise him or her as to the proper course of that for the purpose of accommodating
action, refer the caller to the Poison Control elderly and disabled consumers who have
Center or nearest hospital emergency difficulty using special packaging, Section
room. The national Poison Control Center 4(b) of the PPPA gives medical
phone number is 1-800-222-1222. This practitioners the authority to specify
number should be on or near your conventional packaging for drugs they
telephone, along with those of the fire and prescribe.
police departments. It also would be
prudent to suggest that the caller follow up Q. How can a pharmacist or pharmacy
with his/her physician. determine if the prescription packages they
use meet the special packaging standards?
Q. May I, as a hospital pharmacist, dispense a
regulated drug in a conventional package A. The pharmacy should request special
for use by a patient in the hospital? packaging test data from the manufacturer
or supplier of the prescription packages.
A. Yes, provided that the patient is confined in When ordering packaging, pharmacists
the hospital. Drugs dispensed for outpatient should be aware that vials and closures
use must be packaged in accordance with from different manufacturers may not
the applicable regulations for special function properly when used together.
packaging. Pharmacists are responsible for ensuring
that the packages they use comply with the
Q. Our local hospital sometimes calls upon my PPPA.
pharmacy to provide drugs for patient use
within the hospital. Must these drugs be
dispensed in special packaging?
13
Manufacturers and Packagers Q. Does the drug manufacturer or packager
have to test the packaging to determine if it
Q. What is the responsibility of manufacturers complies with the PPPA standards?
of prescription drugs subject to the PPPA?
A. The packages must meet the standards.
A. If the manufacturer intends that the Failure to meet the standards is a violation
package of a particular oral prescription of federal law. Most packaging
drug is to be dispensed directly to the manufacturers will test their packaging to
patient by the pharmacist, the CPSC determine if it is complies.
interprets the PPPA to require the
manufacturer to market that drug in special Q. Is unit dose packaging considered to be
packaging.31 Such packages are readily child-resistant?
recognizable for the most part and often
only require relabeling by the pharmacists A. Any package that contains a substance
prior to dispensing. The pharmacist, regulated under the PPPA must meet the
however, bears the ultimate responsibility special packaging standards regardless of
for repackaging the drug into special the package type. This includes unit dose
packaging if a manufacturer has failed to packaging such as blisters or pouches. Unit
comply.32 dose packaging is popular for many drugs,
especially OTC drugs. The package is
Q. May the manufacturer supply to the evaluated using the same test methods;
pharmacist one size of a regulated however, the definition of a package failure
prescription drug in a conventional package is different than that of a bottle/closure
under Section 4 of the PPPA in the same package. If a child opens or gains access
manner as supplying a non-complying size to a bottle/closure package, it is counted as
for over-the-counter drugs? a failure for that package. However, a
failure for unit dose packaging is defined as
A. There is no provision for a manufacturer or occurring when a child opens or gains
packager to market a single size of a access to more than eight individual units
prescription drug in noncomplying or the number of units representing a toxic
packaging as is the case for over-the- amount, whichever is less. The level of
counter medications. Every unit of a child-resistance required of the unit
prescription drug subject to the PPPA packaging depends on the toxicity of the
which is packaged by the manufacturer in a product in it. A unit package that is
package intended to be dispensed to a compliant for one drug may not be able to
consumer must be in special packaging. be used to package another more toxic
Regulated prescription drugs may be drug.
dispensed in non-special packaging only
when the prescribing physician directs its
use, or the purchaser requests
noncomplying packaging. In those cases,
the pharmacist would have to repackage
the drug with a conventional, non-special
package.
Q. Can a supplier of special packaging include

an equal number of noncomplying closures
with each carton of complying packaging
shipped to pharmacies?
A. Yes.
14
The Regulatory Agency the regulated product. This is why the
packaging is called child-resistant and not
Q. What role does the U.S. Consumer Product childproof. Further, all adults need not be
Safety Commission play in informing and able to gain entry into the package. The
educating the public in the use of, and need PPPA does not allow the CPSC to mandate
for, special packaging? package designs. These stipulations were
included in the legislation so that industrial
A. The Commission has issued news releases ingenuity would not be stifled.
and other audio-visual material
encouraging the use of special packaging. Q. What is the basis for determining which
In addition, the CPSC is the Secretary of products will be covered by the PPPA?
the Poison Prevention Week Council and
plays an important role in Poison A. The Commission must establish a
Prevention Week each year. relationship between a particular household
substance (because of the way it is
Q. What role does the Commission play in the packaged) and the potential for serious
professional education of health care injury or illness to young children as a result
personnel with respect to the special of ingesting, handling, or using that
packaging program? substance. Some substances do not lend
themselves to this requirement. Ingestion of
A. The CPSC staff interacts with the State a product by children does not
Boards of Pharmacy. CPSC personnel automatically result in the need for special
participate in meetings with pharmaceutical, packaging. For example, many soaps and
medical, and packaging groups and detergents are frequently ingested but do
prepare articles for publication in their not cause serious injury or illness to
journals. One of the areas where the CPSC children. Alternatively, it is not necessary to
staff has been particularly active has been document serious injury to children for the
in encouraging pharmacists to demonstrate Commission to require special packaging of
special package usage to their customers a toxic product.
who need help with the proper method of
opening and closing a special package. Q. Suppose a pharmacist dispenses a
prescription drug in a conventional
Q. Precisely what does the term "special package. What is the CPSC’s position?
packaging” mean?
A. The law requires that the pharmacist
A. Congress defined the term special dispense regulated drugs in special
packaging in the PPPA. The term "special packaging. The only exceptions are those
packaging" means packaging that is instances when the consumer or
designed or constructed to be significantly prescribing physician stipulates that a
difficult for children under 5 years of age to noncomplying package be used.
open or obtain a toxic or harmful amount of Pharmacists who violate the regulations
the substance within a reasonable time and may be criminally prosecuted. Individuals
not difficult for normal adults to use may be sentenced to 1 year imprisonment
properly. However, "special packaging" and fined up to $250,000. Organizations
does not mean packaging which all such may be fined up to $500,000. The
children cannot open or obtain a toxic or Commission could also seek court orders
harmful amount within a reasonable time. enjoining violators or authorizing seizure of
Normal adults are regarded as those with noncomplying products supplied by
no overt physical handicaps, which would manufacturers in consumer packages.
preclude their manipulating the package.
To meet PPPA standards, all children need Q. What is the basis for selecting the
not be prevented from gaining access to noncomplying package, which the law
15
permits for over-the-counter drugs, with the standards is the responsibility of
regulated under the PPPA? the manufacturer. The Commission
assesses compliance on the basis of
A. The manufacturer may select one of its human performance tests.
package sizes as its noncomplying
package so long as it also supplies the Q. What should a pharmacist or physician do if
product in popular size packages, which they know or suspect that PPPA
comply with the PPPA standards. regulations are being violated?
The Commission may require a A. Contact CPSC Headquarters either by

manufacturer to use only special packaging phone, letter, or e-mail. The CPSC
if the manufacturer has not supplied the operates a toll-free hotline at (800) 638-
product in popular size packages which 2772. However, we recommend that you
comply with the standards and the contact the Office of Compliance directly by
Commission finds, after the opportunity for a phone at 301-504-7913, via fax at 301-504-
hearing, that the exclusive use of special 0359, or via e-mail at sect15@cpsc.gov.
packaging is necessary to accomplish the CPSC staff will review the complaint and
child protection intended by the PPPA. take appropriate action as warranted.
Q. The FDA requires tamper-evident Q. Can a State or other political subdivision

packaging for over-the-counter drugs. Does establish packaging regulations that are
this replace the requirement for special more stringent than those promulgated by
packaging? the CPSC?
A. No, the two systems are independent of A. No. With certain narrow exceptions, they
one another. Although there are some must be identical. However, a State may
special packages which are also tamper- require child-resistant packaging of a
evident (blisters, unit-of-use), a tamper- substance not regulated by CPSC.
evident package is not necessarily child-
resistant. The FDA requires that evidence
of tampering be visually determined on Q. Can a State or other political subdivision
initial contact.33 Special packages must establish packaging regulations that are
meet specific performance standards. less stringent than those promulgated by
These include maintaining their child- the CPSC?
resistance for the number of openings and
closings customary for the life of the A. No.
product.
Q. What types of special packaging have been

approved by the Commission for use with
prescription drugs and other regulated
household substances?
A. The Commission does not approve or

certify special packaging. In fact, the PPPA
itself specifically prohibits the Commission
from prescribing specific package designs,
product content, package quantity, and,
with the exception of appropriate labeling
for allowable single, noncomplying package
sizes, labeling. The ultimate determination
of whether a particular package complies
16
SECTION 4
PHARMACY LAW REVIEW
Federal Health Insurance Portability

and Accountability Act
(“HIPAA”)

HIPAA
The Health Insurance Portability and Accountability Act of 1996
What is the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)?
• Protects the confidentiality of Protected Health Information (PHI)

• Violators subject to both civil penalties and criminal sanctions
• Enforced by Office of Civil Rights (OCR) of the U.S. Department of Health and Human
Services
What is protected by HIPAA?
• Protected Health Information (PHI) - In general this means individually identifiable

health information:
o Transmitted by electronic media; or
o Maintained in electronic media; or
o Transmitted or maintained in any other form or medium.
• Individually Identifiable Health Information
o Is created or received by a health care provider, health plan, employer, or health
care clearinghouse; and
o Relates to the past, present, or future physical or mental health or condition of an
individual; the provision of health care to an individual; or the past, present, or
future payment for the provision of health care to an individual; and
o That identifies the individual; or
o With respect to which there is a reasonable basis to believe the information can be
used to identify the individual.
Who is regulated by HIPAA?
• Covered Entities (“CE’s”):

o Health care providers that transmit any health information in electronic form for
billing purposes
o Health plans
o Health care clearinghouses
• Business Associates” of CE’s
o A person or entity that performs services on behalf of a CE and which needs to
receive, use, or disclose PHI in order to perform those services.
o Business Associate must enter into a Business Associate Agreement with its
Covered Entity, containing various required terms
• Examples of CE’s and BA’s:
o Pharmacies are CE’s
o Hospitals are CE’s
o Blue Cross Blue Shield of Illinois is a CE
o Prescription switch vendors (e.g. NDC/Relay Health) are CE’s
o Pharmacy software vendors are BA’s
o Pharmacy’s lawyers and accountants are BA’s
o Pharmacy Benefit Managers are both CE’s and BA’s
o Pharmaceutical companies are generally not CE’s, except with respect to their
own employee health plans
NOTE: Both CE’s and BA’s are required to comply with HIPAA’s Privacy and Security
Regulations
What does HIPAA require?
HIPAA requires that PHI be maintained and used by a CE or BA only for certain purposes
(“TPO”), unless patient authorization is obtained
• Treatment
• Payment
• Health Care Operations
o Examples include-
For legal or auditing services
Accreditation
Formulary development
Disclosures to Law Enforcement
Adverse Event reporting
Compliance with Prescription Drug Monitoring Program requirements
Authorization - Any other use or disclosure of PHI (e.g., other than for TPO) requires the
specific written authorization of the patient
• Authorization form must describe specific use for the PHI, who will receive it, and
whether the CE will be paid in connection with disclosing it.
• CE cannot condition treatment or payment on the signing of an authorization
Authorizations
• Requirements:
o Required for non-TPO disclosures
o Must be in writing
o Must be separate from acknowledgment of Notice of Privacy Practices (see
below)
• Pharmacy cannot refuse treatment if patient declines to sign authorization form
• Authorization to be maintained for SIX (6) years
Authorization is required for the following types of uses/disclosures (among others)

• Marketing - communication about product or service that encourages recipient to
purchase or use the product or service
• Fundraising - when raising funds for entity other than itself
• Employment determinations (pre-employment physicals/drug screens)
• Pre-enrollment underwriting
• Psychotherapy notes
• Any other non-TPO purpose
Exceptions to Authorization – Authorization is not required for certain types of non-TPO uses or
disclosures.
• Fundraising - may use or disclose demographic information and dates of health care
when raising funds for itself
• Face-to-face encounters
• Communications involving promotional gifts of nominal value
• Communications involving treatment, provider’s services, DSM, or coordination of care
• Communications concerning general health issues
Other Exceptions - Authorization not required (and CE or BA may (but is not required) to
disclose PHI to:
• Uses or disclosures required by law

• To public health officials authorized by law to prevent or control disease, investigate
child abuse or neglect, or to FDA
• Adverse event reporting
• Facilitation of product recalls
• Post-marketing surveillance
• Response to court order, subpoena, discovery request, or other lawful purpose
Authorizations – Content; a valid authorization must contain
• Right to revoke authorization

• Patient’s signature and date of signature and expiration date
• Description of information to be used or disclosed
• Name or type of entity receiving the information
• Notification that once the information is used or disclosed pursuant to authorization, it
can be re-disclosed and may no longer be protected
• Descriptions of each use or disclosure
Protections of PHI
• “Minimum Necessary” Standard
o CE or BA must make reasonable efforts to limit use or disclosure of PHI to the
minimum necessary to accomplish the intended purpose of the use of the
information.
o For use and disclosure on a routine and recurring basis, provider must establish
protocols that state what information is necessary for that purpose
o For non-routine requests, must allow for individual review of the request to
determine minimum amount of information used or disclosed to meet the purpose
o Not applicable to TPO
• Notice of Privacy Practices
o In order to use or disclose PHI without the patient’s specific written authorization,
the CE must provide patient with Notice of Privacy Practices, which describes the
specific ways in which it may use or disclose PHI and of other patient rights.
•
• Patient Rights
o Patient has right to request copies of his or her PHI,
o Patient has right to request amendment of PHI
• Business Associates subject to privacy and security obligations similar to those imposed
on CE’s.
“De-Indentification”
• “De-identified” data is not subject to HIPAA restrictions; to qualify as “de-identified

data” all the following must be removed or need statistician’s opinion that inclusion of
the data element will provide only very small risk that the person can be identified
o Names;
o All geographic subdivisions smaller than a State, including street address, city,
county, precinct, zip code, and their equivalent geocodes, except for the initial
three digits of a zip code if, according to the current publicly available data from
the Bureau of the Census:
The geographic unit formed by combining all zip codes with the same
three initial digits contains more than 20,000 people; and
The initial three digits of a zip code for all such geographic units
containing 20,000 or fewer people is changed to 000.
o All elements of dates (except year) for dates directly related to an individual,
including birth date, admission date, discharge date, date of death; and all ages
over 89 and all elements of dates (including year) indicative of such age, except
that such ages and elements may be aggregated into a single category of age 90 or
older;
o Telephone numbers;
o Fax numbers;
o Electronic mail addresses;
o Social security numbers;
o Medical record numbers;
o Health plan beneficiary numbers;
o Account numbers;
o Certificate/license numbers;
o Vehicle identifiers and serial numbers, including license plate numbers;
o Device identifiers and serial numbers;
o Web Universal Resource Locators (URLs);
o Internet Protocol (IP) address numbers;
o Biometric identifiers, including finger and voice prints;
o Full face photographic images and any comparable images;
o Any other unique identifying number, characteristic, or code.
Note: If a patient diagnosis, medication, or other information concerning the condition for
which the patient is receiving health care is appended to any of these “identifiers”, the
information is not “de-identified”, and all HIPAA protections apply to the information.
2010 Development - HITECH Act
Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) is part
of the American Recovery and Reinvestment Act of 2009 (ARRA).
• Amendments to HIPAA
• Provides for enhanced penalties for using PHI for marketing purposes without
authorization
• Breach notification requirements
o The term ‘‘breach’’ means the unauthorized acquisition, access, use, or disclosure
of protected health information which compromises the security or privacy of
such information, except where an unauthorized person to whom such
information is disclosed would not reasonably have been able to retain such
information.
o Business associate to notify Covered Entity of breach it causes
o Covered Entity to notify patient without unreasonable delay, but not later than 60
days after discovery by CE
o Media notice required if the unsecured PHI of more than 500 people reasonably
believed to have been, accessed, acquired, or disclosed during the breach.
HIPAA Security Rule
• Only applies to electronic PHI

• Outlines administrative, physical and technical security safeguards that CE’s must follow
to assure the confidentiality of ePHI
• Examples of Administrative Safeguards include security procedures, security agreements,
disaster recovery plan
• Examples of Physical Safeguards include locked drawers and doors, alarms,
identification badges
• Examples of Technical Safeguards include unique user ID, encryption, automatic time-
out, audit log
Questions
Can a pharmacist use protected health information to fill a prescription that was telephoned in by
a patient's physician without the patient's written consent if the patient is a new patient to the
pharmacy?
• Yes. The pharmacist is using the protected health information for treatment purposes, and
the HIPAA Privacy Rule does not require covered entities to obtain an individual’s
consent prior to using or disclosing protected health information about him or her for
treatment, payment, or health care operations.
Can a patient have a friend or family member pick up a prescription for her?
• Yes. A pharmacist may use professional judgment and experience with common practice
to make reasonable inferences of the patient’s best interest in allowing a person, other
than the patient, to pick up a prescription. For example, the fact that a relative or friend
arrives at a pharmacy and asks to pick up a specific prescription for an individual
effectively verifies that he or she is involved in the individual’s care, and the HIPAA
Privacy Rule allows the pharmacist to give the filled prescription to the relative or friend.
The individual does not need to provide the pharmacist with the names of such persons in
advance.
Can health care providers engage in confidential conversations with other providers or with
patients, even if there is a possibility that they could be overheard?
• Yes. The HIPAA Privacy Rule is not intended to prohibit providers from talking to each
other and to their patients. Provisions of this Rule requiring covered entities to implement
reasonable safeguards that reflect their particular circumstances …. The Privacy Rule
also recognizes that overheard communications in these settings may be unavoidable and
allows for these incidental disclosures.
o For example...
- A pharmacist may discuss a prescription with a patient over the
pharmacy counter, or with a physician or the patient over the phone.
In these circumstances, reasonable precautions could include using
lowered voices or talking apart from others when sharing protected health
information.
Can a doctor or pharmacy be paid to make a prescription refill reminder without a prior
authorization under the HIPAA Privacy Rule?
• Yes. It is not marketing for a doctor to make a prescription refill reminder even if a third
party pays for the communication. The prescription refill reminder is considered
treatment and is therefore excluded from the definition of marketing and does not require
a prior authorization. Similarly, it is not marketing when a doctor or pharmacy is paid by
a pharmaceutical company to recommend an alternative medication to patients.
Communications about alternative treatments are excluded from the definition of
marketing and do not require a prior authorization. The simple receipt of remuneration
does not transform a treatment communication into a commercial promotion of a product
or service. However, a covered entity would require an authorization if it sold protected
health information to a third party for the third party’s marketing purposes.
Does the HIPAA Privacy Rule restrict pharmacists from giving advice about over-the-counter
medicines to customers?
• No. A pharmacist may provide advice to customers about over-the-counter medicines.

The Privacy Rule permits a covered entity to disclose protected health information about
an individual to the individual.
May pharmacists leave messages for patients at their homes, either on an answering machine or
with a family member, to remind them of appointments or to inform them that a prescription is
ready?
• Yes. The HIPAA Privacy Rule permits health care providers to communicate with
patients regarding their health care. This includes communicating with patients at their
homes, whether through the mail or by phone or in some other manner. In addition, the
Rule does not prohibit covered entities from leaving messages for patients on their
answering machines. However, to reasonably safeguard the individual’s privacy, covered
entities should take care to limit the amount of information disclosed on the answering
machine. For example, a covered entity might want to consider leaving only its name and
number and other information necessary to confirm an appointment, or ask the individual
to call back. (continued)
• A covered entity also may leave a message with a family member or other person who
answers the phone when the patient is not home. The Privacy Rule permits covered
entities to disclose limited information to family members, friends, or other persons
regarding an individual’s care, even when the individual is not present. However, covered
entities should use professional judgment to assure that such disclosures are in the best
interest of the individual and limit the information disclosed.
Is a pharmacist permitted to have customer acknowledge receipt of the notice by signing or

initialing the log book that they already sign when they pick up prescriptions?
• Yes, provided that the individual is clearly informed on the log book of what they are
acknowledging and the acknowledgment is not also used as a waiver or permission for
something else that also appears on the log book (such as a waiver to consult with the
pharmacist). The HIPAA Privacy Rule provides covered health care providers with
discretion to design an acknowledgment process that works best for their businesses.
Can contractors (business associates) use protected health information for their own marketing
purposes?
• No. While covered entities may share protected health information with their contractors
who meet the definition of “business associates” under the HIPAA Privacy Rule, that
definition is limited to contractors that obtain protected health information to perform or
assist in the performance of certain health care operations on behalf of covered entities.
Thus, business associates, with limited exceptions, cannot use protected health
information for their own purposes.
• Further, the Privacy Rule expressly prohibits health plans and covered health care
providers from selling protected health information to third parties for the third party’s
own marketing activities, without authorization. So, for example, a pharmacist cannot,
without patient authorization, sell a list of patients to a pharmaceutical company, for the
pharmaceutical company to market its own products to the individuals on the list.

2019 IL and Federal Pharmacy Law Review PDF

Caricato da

Informazioni sul documento

Titolo originale

Copyright

Formati disponibili

Condividi questo documento

Condividi o incorpora il documento

Opzioni di condivisione

Hai trovato utile questo documento?

Questo contenuto è inappropriato?

Copyright:

Formati disponibili

2019 IL and Federal Pharmacy Law Review PDF

Caricato da

Copyright:

Formati disponibili

2019 Illinois and Federal Pharmacy Law Review

Section 1 Pharmacy Law Review – Main Handout

Section 2 Practice Exam Questions

Section 3 Federal Poison Prevention Packaging Act

Section 4 Federal Health Insurance Portability and Accountability Act

© 2019 Edward D. Rickert (All Rights Reserved)

PHARMACY LAW REVIEW

© 2019 Edward D. Rickert (All Rights Reserved)

GENERAL EXAM INFORMATION

Time allotment - 2.5 hours

• The number of questions was increased from 90 to 120 questions in 2016.

AREAS COVERED ON EXAM

Area 1 – Pharmacy Practice (83%)

Area 2 – Licensure, Registration, Certification, and Operational Requirements (15%)

Area 3 – General Regulatory Processes (2%)

Exam Format (Directly from MPJE® Bulletin)

• Ordered Response Question Format:

Unordered Options Ordered Response

GENERAL TIPS FOR SUCCESS

• Once a scheduled substance leaves the “closed system”, it cannot re-enter.

Applying for a DEA Registration

• Materially falsified information in application;

• Proof of federal registration and payment of registration fee. No additional requirements.

• Add digits 1, 3, and 5

• Add digits 2, 4, and 6, and multiply the sum by two.

• Hydrocodone /APAP (Vicodin, Lortab, Norco)

• Anabolic steroids have been placed in this category.

• Generally: Anxiolytics; sedatives

• Mainly: Cough; Cold; Anti-diarrheals

General Rules for Scheduling

Exempt Narcotics - Dispensing Schedule V Controlled Substances without Prescription

Requirement Illinois Law Federal Law

Time Limitation at least 96 hours at least 48 hours

Refills if RX Max of 5 refills or 6 months, No max time limit or refills

Illinois PSE and EPH Laws

Answer: Two step process:

Step 2: Determine amount of codeine per dose

Therefore, this RX is for a C II controlled substance, and cannot be refilled!

Ordering Controlled Substances

• The form may be refused by the seller/distributor:

CSOS subscribers achieve the following benefits:

3. A veterinarian purchases a bottle of Ketamine from a pharmacy:

4. A pharmacy returns a bottle of unused morphine to the manufacturer.

Lost or Stolen Forms (21 CFR § 305.16)

Illinois C-II Duplicate Order Requirement

Ordering C-III through C-V Substances

• No special form required.

• If oral, reduced to writing by pharmacist with same information.

• Federal law defers to state law.

Transmitting CII prescriptions to pharmacy:

d) Patient ID for Proper Filling:

Prescription Requirements For Schedules III, IV and V (720 ILCS 570/312)

Partial Dispensing of Schedule II Controlled Substance Prescriptions

Exam Tip: Partial fills are NOT counted as full refills.

Transferring Controlled Substance Prescriptions (CS Regulations defer to 68 IL ADC 1330.720)

Labels for Controlled Substance Prescriptions

Prescription Filing Systems

• Inventory should state whether it was taken at opening or close of business.

Controlled Substance Theft or Loss (DEA Form 106 Requirements)

• The schedule of the missing items.

• Section 1330.710 Reporting Theft or Loss of Controlled Substances

Ryan Haight Online Consumer Protection Act

Miscellaneous Controlled Substance Laws