1.

CONTROLLED SUBSTANCES
This section is extremely important in the preparation for the MPJE exam in that the MPJE
competency statements mention the term "controlled substances" in 13 different areas. A strong
understanding of the competency statements as they relate to controlled substances will provide a
strong start to preparing for the MPJE. Just as importantly, New Jersey law differs from federal law
in more than 20 different areas dealing with controlled substances. The differences are carefully
pointed out in the margins of the text.

1.1 Schedules
Controlled Substances are divided into 5 schedules based on their dependence potential and abuse
potential.

Physical Psychological
Schedule
Dependence Dependence
I High High
II High Severe
III Moderate High
IV Limited Limited
V Low Limited
Dependence Potentials. This table lists the dependence potentials for Schedules I-V.
 SCHEDULE I EXAMPLES
Methaqualone LSD
Heroin Marijuana
Mescaline Peyote
GHB

SCHEDULE II EXAMPLES
Amobarbital Amphetamines (Dexedrine, Adderall)
Cocaine Diphenoxylate
Fentanyl (Duragesic, Actiq, Fentora, Lazanda) Hydromorphone (Dilaudid)
Meperidine (Demerol) Methadone (Dolophine)
Methamphetamine (Desoxyn) Methylphenidate (Ritalin, Concerta)
Morphine MS Contin
Oxycodone (Tylox, Percocet, Percodan) Oxycontin
Pentobarbital (Nembutal) Secobarbital (Seconal)
Oxymorphone (Opana) Tapentadol (Nucynta)
Nabilone (Cesamet) Codeine
Hydrocodone/APAP (Vicodin, Lorcet) Hycodan
Tussionex Hydrocodone/Ibuprofen (Vicoprofen)

SCHEDULE III EXAMPLES

Anabolic Steroids* (see table below) Codeine/ASA
Buprenorphine (Subutex) Buprenorphine/Naloxone (Suboxone)
Fiorinal/Codeine Paregoric
Dronabinol (Marinol) Tylenol/Codeine Tablets
Xyrem (gamma hydroxybutyric acid) sodium oxybate

ANABOLIC STEROIDS (SCHEDULE III DRUGS)

Ethylestrenol (Maxibolin) Nandrolone decanoate (Deca Durabolin)
Stanozolol (Winstrol) Fluoxymesterone (Halotestin)
Testosterone Patch (Androderm, Testoderm Oxandrolone (Anavar)
Methandrostenolone (Dianabol) Oxymetholone (Anadrol)
 SCHEDULE IV EXAMPLES
Alprazolam (Xanax) Butorphanol (Stadol)
Chloral Hydrate (Noctec) Chlordiazepoxide (Librium)
Clonazepam (Klonopin) Clorazepate (Tranxene)
Diazepam (Valium) Ethchlorvynol (Placidyl)
Flurazepam (Dalmane) Lorazepam (Ativan)
Oxazepam (Serax) Pentazocine (Talwin)
Tramadol (Ultram) Temazepam (Restoril)
Zolpidem (Ambien) Halazepam (Paxipam)
Midazolam (Versed) Mazindol (Sanorex)
Phenobarbital Triazolam (Halcion)
Carisoprodol (Soma) Modafinil (Provigil)
Zaleplon (Sonata) Eszopiclone (Lunesta)

SCHEDULE V EXAMPLES
Actifed/Codeine Lomotil
Novahistine Expectorant Novahistine DH
Phenergan/Codeine Phenergan VC/Codeine
Robitussin AC Tylenol/Codeine Liquid
Tussi-Organidin NR Pregabalin (Lyrica)

Schedule Examples, cont. This table lists the schedules for some common controlled substances.

Maximum Ingredient Per

NMT 1.8 gm of Codeine* 100 ml
NMT 90 mg of Codeine* Dosage unit
NMT 1.8 gm of Dihydrocodeine* 100 ml
MNT 90 mg of Dihydorocodeine* Dosage Unit
NMT 300 mg of Ethylmorphine* 100 ml
NMT 15 mg of Ethylmorphine* Dosage Unit
NMT 500 mg of Opium* 100 ml
NMT 25 mg of Opium* Dosage Unit
NMT 50 mg of Morphine* 100 ml
*With one or more active, non-narcotic
ingredients in recognized therapeutic
amounts.

Schedule III Limitations. This table indicates the quantity limitations for classification as a
Schedule III substance.

Maximum Ingredient Per

NMT 200 mg of codeine* 100 ml
NMT 100 mg of dihydrocodeine* 100 ml
NMT 100 mg of ethylmorphine* 100 ml
NMT 100 mg of opium* 100 ml
NMT 2.5 mg of diphenoxylate, & NLT 25 ug/ atropine sulfate Dose
NMT 0.5 mg of difenoxin &NLT 25 ug of atropine sulfate Dose
*With one or more active, non-narcotic active medicinal ingredients in sufficient
portion to confer upon the mixture or compound valuable medicinal qualities other
than possessed by the narcotic alone.
Schedule V Limitations. This table indicates the quantity limitations for classification as a
Schedule V substance.

Schedule I drugs have no currently accepted medical use.

Note that Cocaine is a Schedule II substance – not Schedule I.
Hydrocodone-combination products changed from Schedule III to Schedule II
effective October 6, 2014.
Schedule II substances in suppository form become Schedule III substances.
Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note
on the face of the prescription the medical need of the patient for the prescription.
The DEA has moved Carisoprodol into Schedule IV as of January 2012.
Tramadol (Ultram) was classified by the DEA as a Schedule IV on August 18, 2014
Notice that most CV substances are cough suppressants and anti-diarrheals.

Some examples of Schedule III narcotics include products containing not more than
90 milligrams of codeine per dosage unit (e.g., codeine with acetaminophen, aspirin,
or ibuprofen).
It is easier to remember liquid maximums by converting all of the maximums in the
table to mg/ml. For example, NMT18 mg/ml and NMT 2 mg/ml of codeine for CIII and
CV respectively instead of NMT1.8 gms of codeine/100 ml and NMT 200 mg. of
codeine/100 ml.
 1.2 Scheduling Authority
Scheduling authority is vested solely with the Attorney General. However, the Attorney General
must first request a scientific and medical evaluation of the drug from the Secretary of the
Department of Health and Human Services (HHS). The recommendation of the secretary with
regard to medical and scientific matters is binding on the Attorney General. However, if the Attorney
General finds that a drug must be placed into Schedule I to avoid an “imminent hazard to public
safety,” he/she may do so without consulting the Secretary of HHS.

1.3 Emergency (Telephone/Fax order) Dispensing of

Schedule II Drugs
Permitted if an emergency exists. An emergency exists if
• Immediate Administration of Schedule II substance is necessary
• No alternative treatment is available (i.e., would a Schedule III work?)
• It is not reasonably possible for the prescriber to present a written prescription prior to dispensing

1.3.1 Requirements related to emergency dispensing

• The quantity dispensed should only be enough to get the patient through the emergency period
• The prescription must be immediately reduced to writing
• A reasonable effort must be made to ascertain that the oral authorization came from a registered
individual practitioner
• Within 7 days, the physician must have delivered (or postmarked) a prescription to the pharmacy,
with the words “Authorization for emergency dispensing”
• The pharmacist must attach the written prescription to the oral emergency written prescription that
has been reduced to writing
• Failure of the physician to deliver a written prescription requires that the pharmacist notify the DEA
• Failure to notify the DEA voids the authority of the pharmacy to accept emergency oral orders for
Schedule II Substances

In NJ, the emergency period is specifically limited to a 72 hours' supply.

In NJ, if the practitioner does not deliver a prescription to cover the emergency
quantity within 7 days, the pharmacy must contact the DEA AND the DCU. Failure of
the pharmacist to do so shall void the authority to accept emergency CII
prescriptions.

1.4 Partial Filling of CII Prescriptions

• Amount dispensed must be noted on the face of the prescription
• If the balance is unable to be filled or is not filled within 72 hours, the pharmacist must notify the
prescriber--either to get a new prescription for the balance owed or to let him/her know that the Rx
was not completely filled.
1.4.1 Exceptions to the 72 hour rule for partial filling
Long-term care facilities may dispense partial quantities of schedule II prescriptions up to 60 days.
Pharmacist may also dispense partial quantities of schedule II prescriptions up to 60 days to patients
with a medical diagnosis documenting a terminal illness.
 1.4.2 The dispensing pharmacist shall record:
• The date of the partial filling
• Quantity dispensed
• Remaining quantity authorized to be dispensed
• The identification of the dispensing pharmacist

The pharmacist must record on the prescription whether the patient is terminally ill
or an LTCF patient
Having to note the remaining quantity may seem unusual, but it is simply a
housekeeping measure to insure that the total quantity on the original prescription is
not exceeded.
DEA requires real time updating of computer info and ability to readily retrieve
original Rx info and listing of all partial fills.

1.5 Partial Filling of CIII-CV

Partial filling of CIII through CV is permissible provided that:
• Each partial filling is recorded in the same manner as a refill
• Total quantity prescribed in all partial fillings does not exceed the total quantity prescribed
• No dispensing occurs beyond 6 months after the prescription is issued

Do not confuse partial filling of a CIII-CV with a refill of same. Only 5 refills are
allowed but greater than 5 partial fillings are allowed

1.6 Filing Methods for Controlled Drug Prescriptions

Prescriptions for Schedule II substances shall be maintained in a separate prescription
file. Prescriptions for Schedule III, IV, and V substances shall be maintained in a separate file only
or in such form that they are “readily retrievable” from the other prescription records of the
pharmacy. Prescriptions are deemed “readily retrievable” if at the time they are initially filled:
• The face of the prescription is stamped in red ink in the lower right corner with the letter “C” no less
than one inch high and;
• Filed in the prescription file for controlled substances listed in schedule II, or
• In the usual consecutively numbered prescription file for non-controlled substances

“3-2-2” Filing Method

II III-V Non-Controlled Substances
II III-V, Non-Controlled Substances
II, III-V Non-Controlled Substances
 Filing Methods. This chart depicts the 3 alternative methods for storing controlled substance
prescriptions.
However, if a pharmacy employs a computer system for prescriptions that permits
identification by prescription number and retrieval of original documents by
prescriber’s name, patient’s name, drug dispensed, and date filled, then the
requirement to mark the hard copy with the red C is waived under federal law, and
under New Jersey law.

Note that a Red "C" would not be required for the filing method in the first row since
the III-V would be readly retrievable since they are already separated.

1.7 Inventory Requirements for Controlled Substances

• Before a pharmacy commences business, an initial inventory must be taken (even if inventory is
zero). The inventory must contain a complete and accurate count of all controlled substances “on
hand” i.e., in the possession of, or under the control of the registrant
• Biennial (every 2 years) inventory requirements apply to controlled substances. After the initial
inventory is taken, the registrant shall take a new inventory on any date that is within two years of
the previous biennial inventory date (note the different rule in NJ)
• Newly scheduled drugs must be inventoried the day they become scheduled and again with the
next inventory. It is the pharmacists' responsibility to know when a drug will become newly
scheduled
• Schedule I and II drugs need to be counted exactly
• Schedule III, IV, and V drug counts can be estimated unless the original container from the
manufacturer contained MORE THAN 1,000 tablets or capsules, in which case an exact
count must be taken
• Inventory records must be maintained for 2 years at the inventory location
• Ok to record inventory as long as it is promptly transcribed
• Inventory must be taken at beginning or close of business and time must be recorded on
inventory record
• Recommended, but not required to record signatures of those taking the inventory
• Inventory must be taken if there is a change in ownership
• Inventory records for CII must be kept separately
• Inventory records for CIII-V must be “readily retrievable”

In NJ, the inventory date can be on

-Day of the year on which original inventory was taken, or

-Regular general physical inventory date, which is nearest to and does not vary by
more than 6 mos. from date that would otherwise apply

-Any other fixed date using same 6 mo. Rule

For allowance of either 6-mo rule application, registrant must notify the DEA and
DCU of the date that the inventory will be taken

Similarly, in NJ the pharmacy can take the CS inventory on a date that is within 4
days of the biennial date as long as the DCU is notified as to the date the inventory
was taken when the pharmacy renews its DCU annual registration
NJ also requires an inventory to be taken for a change in the PIC

Controlled substance inventories are not mailed to any agency

1.8 Central Recordkeeping

For certain registrants (e.g., chain pharmacies) it may be more feasible for them to store controlled
substance records at a central location. This is permitted by the DEA provided that they are notified
14 days in advance, in triplicate, by registered or certified mail, return receipt requested (assuming of
course, that they don’t deny the request).
One must tell the DEA what records will be kept centrally, their exact location, name, address, DEA
number, and type of registration, and whether manual or computerized, and any access codes, etc.
Upon written request from the DEA, the registrant must provide requested central records to the
registered location within 2 business days. Alternatively, the DEA can show up unannounced and
inspect records at the central record keeping site without a warrant of any kind
Failure to comply with the above conditions may result in canceling the central record keeping
authorization without a hearing
In NJ must - make the records available to the DCU in addition to the DEA.
Note: Central Record Keeping may not include Prescriptions, Inventory Records, and
Executed 222 order forms.
Central Record Keeping may include unexecuted 222 order forms.

1.9 Ordering Procedure for Schedule II Substances (DEA

Form 222)
Order forms may be requisitioned by using DEA form 222a, which when completed are sent to the
Registration Unit of the DEA in Washington, DC.
When completing a DEA 222 order form, the purchaser keeps copy 3 and mails copies 1 and 2 to
the supplier.Upon completion, the supplier sends copy 2 to the DEA.
No alterations, erasures, or “white-outs” are permitted.If a mistake is made, simply mark all 3 copies
“VOID” and store with other executed order forms.DO NOT THROW AWAY THE DEA 222 FORM
CONTAINING THE ERROR.
The DEA 222 order form may be signed by the registrant or by someone who has been given
the power of attorney to execute the form.
If an order cannot be filled completely, the supplier has 60 days from the date of the execution of
the order form to supply the balance.
The supplier can also “endorse” the reverse side of the DEA 222 order form to another supplier if
they don’t have the item ordered..
Order forms for Carfentanil, Etorphine Hydrochloride, and Diprenorphine shall contain only these
substances.
It is very important for the pharmacy to record the number of containers received and the date
received on copy 3.
 A purchaser may cancel part or all of an order by notifying the supplier in writing. The supplier shall
indicate the cancellation on copies 1 and 2 by drawing a line and marking the item “cancelled”.
A supplier may void part or all of an order on a DEA Form 222 by notifying the purchaser in writing.
The supplier must indicate the voiding in Copies 1 and 2 of the DEA Form 222 by drawing a line
through the cancelled item(s) and printing “void” in the space provided for the number of items
shipped.

Note that the pharmacy cannot cancel a line item on its own by drawing a line and
marking the item “cancelled”

A pharmacist or pharmacist manager is not automatically eligible to complete a 222

form. If you are not the registrant, then in order for you to be able to order on a DEA
222 order form, there needs to be a completed power of attorney allowing you to do
that.
1.10 Controlled Substance Ordering Systems
(CSOS) Electronic Order Forms
A pharmacy may order schedule II controlled substances electronically via the DEA Controlled
Substance Ordering System (CSOS) and maintain the records of these orders electronically for two
years. The use of electronic orders is optional; registrants may continue to issue orders on a
paper DEA Form 222. CSOS allows for secure electronic transmission of controlled substance
orders without the supporting paper DEA Form 222. CSOS requires users to obtain a CSOS digital
certificate for electronic ordering. The electronic orders are signed using a digital
signature. When a purchaser receives a shipment, the purchaser must create a record of the
quantity of each item received and the date received. The record must be electronically linked
to the original order and archived.
Digital certificates can be obtained only by registrants and individuals granted power of attorney.
A registrant must appoint a CSOS coordinator who will serve as that registrant's recognized
agent regarding issues pertaining to issuance of, revocation of, and changes to, digital certificates
issued under that registrant's DEA registration. A CSOS digital certificate will normally be valid until
the DEA registration under which it is issued expires. Digital Certificates will also be revoked if the
certificate holder is no longer authorized to sign schedule II orders for the registrant, if the
information on which the certificate is based changes, or if the digital certificate used to sign
electronic orders has been compromised, stolen, or lost.

1.10.1 Unaccepted and Defective Electronic Orders

An electronic order for controlled substances may not be filled if any of the following occurs:
• The required data fields have not been completed.
• The order is not signed using a digital signature issued by DEA.
• The digital certificate used has expired or been revoked prior to signature.
• The purchaser’s public key will not validate the digital certificate.
• The validation of the order shows that the order is invalid for any reason.
If an order cannot be filled, the supplier must notify the purchaser and provide a statement as to the
reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any
order. If a supplier refuses, a statement that the order is not accepted is sufficient.
When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must
electronically link the statement of nonacceptance to the original order. The original statement must
be retained for two years. Neither a purchaser nor a supplier may correct a defective order. The
purchaser must issue a new order for the order to be filled.

A “Questions and Answers” page about the CSOS certificate is available

on the DEA E-Commerce Program website
at https://www.deaecom.gov/qanda.html
Think of the digital certificate as the electronic equivalent of a DEA 222
Form.

1.10.2 Cancellation and Voiding of Electronic Orders

A supplier may void all (or part) of an electronic order by notifying the purchaser of the voiding. If the
entire order is voided, the supplier must make an electronic copy of the order and indicate “Void” on
the copy and return it to the purchaser. The supplier is not required to retain a record of orders that
are not filled. The purchaser must retain an electronic copy of the voided order. Should a supplier
partially void an order, the supplier must indicate in the linked record that nothing was shipped for
each item voided.

1.10.3 Lost Electronic Orders

If a purchaser determines that an unfilled electronic order has been lost before or after receipt, the
purchaser must provide, to the supplier, a signed statement. This statement must include the unique
tracking number and date of the lost order and state that the goods covered by the first order were
not received through loss of that order. If the purchaser executes a new order to replace the lost
order, the purchaser must electronically link an electronic record of the second order and a copy of
the statement with the record of the first order and retain them both. If the supplier to whom the order
was directed subsequently receives the first order, the supplier must indicate that it is “not accepted”
and return it to the purchaser. The purchaser must link the returned order to the record of that order
and the statement.

1.10.4 DEA records for Electronic Orders

For each electronic order filled, a supplier must forward either a copy of the electronic order or an
electronic report of the order in a format that DEA specifies to DEA within two business days.

1.11 Electronic Prescriptions for Controlled

Substances
The final rule on Electronic Prescriptions for Controlled Substances became effective June 1, 2010.
The rule provides practitioners with the option of writing prescriptions for controlled substances
electronically and for pharmacies to receive, dispense, and archive these electronic prescriptions.
Persons who wish to dispense controlled substances using electronic prescriptions must select
software that meets the requirements of this rule. Only those electronic pharmacy applications that
comply with all of DEA’s requirements as set forth in 21 C.F.R. §1311 may be used by DEA-
registered pharmacies to electronically receive and archive controlled substances prescriptions and
dispense controlled substances based on those prescriptions.

1.11.1 Meeting DEA Application Requirements

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 provides the
audit/certification report to the pharmacy. The audit report the pharmacy will receive from the
pharmacy application provider will indicate if the application is capable of importing, displaying, and
storing DEA-required prescription information accurately and consistently.
If the third-party auditor or certification organization finds that a pharmacy application does not
accurately and consistently import, store, and display other information required for prescriptions, the
pharmacy must not accept electronic prescriptions for controlled substances that are subject to the
additional information requirements. For example, until the audit or certification report indicates that
the pharmacy application can import, display, and store both a hospital DEA number and the
individual practitioner’s extension number, the pharmacy must not accept electronic prescriptions
that include only a hospital DEA registration number. The pharmacy may, however, use the
application to process other controlled substance prescriptions if the audit or certification report has
found that the pharmacy application meets all other requirements.
When a pharmacist fills a prescription in a manner that would require a notation on the prescription if
the prescription were a paper prescription, the pharmacist must make the same notation
electronically when filling an electronic prescription and retain the annotation electronically in the
prescription record or linked files. When a prescription is received electronically, the prescription and
all required annotations must be stored electronically.

1.11.2 Simultaneous Paper and Electronic Prescriptions--

Avoiding Duplicate Filling
When a pharmacist receives a paper or oral prescription that indicates that it was originally
transmitted electronically to the pharmacy, the pharmacist must check the pharmacy’s records to
ensure that the electronic version was not received and the prescription dispensed. If both
prescriptions were received, the pharmacist must mark one as void.
When a pharmacist receives a paper or oral prescription that indicates that it was originally
transmitted electronically to another pharmacy, the pharmacist must check with that pharmacy to
determine whether the prescription was received and dispensed. If the pharmacy that received the
original electronic prescription had not dispensed the prescription, that pharmacy must mark the
electronic version as void or cancelled. If the pharmacy that received the original electronic
prescription dispensed the prescription, the pharmacy with the paper version must not dispense the
paper prescription and must mark the prescription as void.

1.11.3 Prescriber 2-factor Authentication

Prescribers writing prescriptions for controlled substances are required to use a two-factor
authentication. The DEA is allowing the use of two of the following – something you know (a
knowledge factor such as a password), something you have (a hard token stored separately from
the computer being accessed), and something you are (biometric information.
 1.12 Ryan Haight Online Pharmacy Consumer Protection
Act
This Act amends the CSA to prevent the illegal distribution of CS on the Internet. Effective 4/13/09,
pharmacies must get a modification of existing DEA registration to allow operation of an online
pharmacy. It also imposes reporting and disclosure requirements.

1.12.1 Exemptions
Exempted from the definition of “online pharmacy” are pharmacies registered with the DEA whose
dispensing of controlled substances via the Internet consist solely of refilling prescriptions for CS in
schedule III, IV, or V; or filling new prescriptions in schedule III, IV, or V where the pharmacy had
previously filled a non-internet prescription for the same patient and at the patient’s request contacts
the prescriber for a new prescription. Significantly, this means that the majority of brick and mortar
pharmacies that also maintain a website are not considered "online pharmacies" and therefore not
subject to the onerous disclosure and reporting requirements.

1.12.2 Additional Requirements

A statement must be placed on the pharmacy’s home page that includes:
• Statement that the pharmacy complies with the Act;
• Name, address, e-mail address, and telephone number of the pharmacy
• Name, professional degree, and states of licensure for the pharmacist-in-charge, and a telephone
number at which the PIC may be contacted
• List of states in which the pharmacy is licensed
• Certification that pharmacy is registered with DEA as an online pharmacy
• The name, address, tele. #, professional degree, and states of licensure of any practitioner who has
a contractual relationship with the pharmacy
The following statement must also be posted: “This online pharmacy is obligated to comply fully with
the Controlled Substances Act and DEA regulations. As part of this obligation, this online pharmacy
has obtained a modified DEA registration authorizing it to operate as an online pharmacy. In
addition, this online pharmacy will only dispense a controlled substance to a person who has a valid
prescription issued for a legitimate medical purpose based upon a medical relationship with a
prescribing practitioner. This includes at least one prior in-person medical evaluation in accordance
with section 309 of the Controlled Substances Act (21 U.S.C. § 829), or a medical evaluation via
telemedicine in accordance with section 102(54) of the Controlled Substances Act (21 U.S.C. §
802(54)).”
Online pharmacies must register with the DEA 30 days prior to engaging in Internet
pharmacy involving controlled substances. In addition, online pharmacies must
contact the respective boards of pharmacy for all the states they wish to do business
in at least 30 days prior as well.

Monthly reports must be made to the DEA of the quantity of each CS dispensed by
the pharmacy, if, during the month in question, the pharmacy has dispensed at least
100 prescriptions or at least 5,000 dosage units. Reporting is by NDC number. Keep
 in mind that most pharmacies are exempt from these requirements because they are
exempted from the definition of online pharmacy.

1.13 In Transit Losses

When all or part of an in-transit shipment of controlled substances fails to reach its intended
destination, the supplier is responsible for reporting the in-transit loss of controlled substances to
DEA. The purchaser is responsible for reporting any loss of controlled substances
after signing for or taking custody of a shipment. If it is discovered after that point that an in-
transit loss or theft has occurred; the purchaser must then submit a DEA Form 106. If the purchaser
does not take custody of the shipment and instead returns it to the supplier, it is the supplier’s
responsibility for reporting any loss of controlled substances in the original shipment.

1.13.1 In Transit loss from Central Fill Pharmacy

When a central fill pharmacy contracts with private, common or contract carriers to transport filled
prescriptions to a retail pharmacy, the central fill pharmacy is responsible for reporting the in-transit
loss upon discovery of such loss by use of a DEA Form 106. In addition, when a retail pharmacy
contracts with private, common or contract carriers to retrieve filled prescriptions from a central fill
pharmacy, the retail pharmacy is responsible for reporting in-transit losses upon discovery using a
DEA Form 106.
Whoever has custody of the CS determines who needs to report losses. If a
pharmacy has not signed off on a delivery, then the supplier would have to report
any in transit losses. Similarly, in the case of central filling, whichever party (i.e.,
retail pharmacy or central fill pharmacy) contracts with Fed Ex etc. would be
responsible to report any in-transit losses.

In New Jersey, the DCU must also be notified in the event of in transit losses

1.14 Lost or Stolen Order Forms

1.14.1 Order Forms Lost or Stolen in Transit
If a pharmacy determines that an unfilled 222 order form has been lost, the pharmacy executes
another order form in addition to a statement containing the following information about the original
order:
• The serial number
• The date of the lost form
• A statement stating that the goods covered by the first order form were not received through loss of
that order form
A copy of the statement shall be attached to Copies 1 and 2 of the second order form sent to the
supplier as well as Copy 3 of the second order form being retained at the pharmacy.
If the supplier subsequently receives the first order form to whom it was directed, the supplier shall
mark upon the face thereof ‘‘not accepted’’ and return Copies 1 and 2 to the purchaser, who shall
attach it to Copy 3 and the statement.
1.14.2 Order Forms Lost or Stolen (Used or Unused—Not in Transit)
Whenever any used or unused order forms are stolen or lost (otherwise than in the course of transit)
by any purchaser or supplier, he/she shall immediately upon discovery of such theft or loss, report
the same to the Special Agent in Charge of the Drug Enforcement Administration 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 order forms received from purchasers and the supplier is
unable to state the serial numbers of such order forms, he/she shall report the date or approximate
date of receipt thereof and the names and addresses of the purchasers.
If an entire book of order forms is lost or stolen, and the purchaser is unable to state the serial
numbers of the order forms contained therein, he/she shall report, in lieu of the numbers of the forms
contained in such book, the date or approximate date of issuance thereof. If any unused order form
reported stolen or lost is subsequently recovered or found, the Special Agent in Charge of the Drug
Enforcement Administration in the Divisional Office responsible for the area in which the registrant is
located shall immediately be notified.
The purpose of the notes is to alert everyone in the process of a potential issue, from
the wholesaler which gets the second order, to the DEA which gets notice when they
receive copy 2 of the second order from the wholesaler, to the DEA inspector who
may be checking the pharmacy and wondering why copy 3 of the original 222 order
form has not been marked with the number of packages received and date received.

Copy 3 of the second 222 order form shall be retained with Copy 3 of the order form
first executed.

Whenever any used or unused forms are stolen or lost (other than in transit) by any
purchaser or supplier, the purchaser or supplier shall also notify the
DCU immediately. Similarly, if any form is found that was reported as stolen or lost,
the DCU gets notified immediately.

Although there is no requirement that 222 forms be used sequentially, it certainly

makes sense to do so, considering the reporting requirements listed for lost and/or
stolen order forms.

1.15 Registration for Controlled Substance Activity

1.15.1 Registration Requirements
Currently, Pharmacies are required to register with the Attorney General every 3 years (Triennially)
Pharmacists are not required to register individually
Separate registrations for each pharmacy owned or operated by the same firm are required under
DEA regulations. However, a hospital registered with the DEA generally does not need to have
separate DEA registrations for decentralized pharmacy services or for satellite pharmacies if they
are all part of the same physical structure. A hospital would have to obtain a separate registration
for any retail pharmacy that they operated for servicing the public.
 Manufacturers and Distributors must register Annually
Generally, a separate registration is required for each activity; however, certain coincidental activities
do not require separate registration.For example, a manufacturer need not register as a distributor to
distribute their products to the wholesaler
Similarly, a pharmacy may “distribute” controlled substances to another pharmacy or physician, for
example, without having to register as a distributor, provided that such sales amount to less than 5%
of all controlled substances dispensed and distributed in a year

1.15.2 Exemptions from Registration

Individual practitioners must ordinarily be registered with the DEA to prescribe controlled
substances. (e.g., physicians, dentists, veterinarians, etc.); however, if the individual practitioner is
an agent or employee of a hospital or other institution, the practitioner may, while acting in the
normal course of business or employment, administer, dispense, and prescribe controlled
substances under the registration of the hospital or institution provided that:
• The dispensing, administering, or prescribing is done in the usual course of professional practice
• The individual practitioner is authorized or permitted to do so by the jurisdiction in which he is
practicing
• The hospital or other institution by which practitioner is employed has verified that the practitioner is
so permitted to dispense, administer, or prescribe drugs within the jurisdiction
• The individual practitioner is acting only within the scope of his employment in the hospital or
institution
• The hospital or institution or other institution authorizes the intern, resident, or foreign-trained
physician to dispense or prescribe under the hospital registration and designates a specific internal
code number for each intern, resident, or foreign-trained physician so authorized.The code number
shall consist of numbers, letters, or a combination thereof and shall be a suffix to the institution’s
DEA registration number, preceded by a hyphen (e.g., AP 0123456-10) or (AP 0123456-A12)
• The list of codes and respective practitioners is made available to other registrants and law
enforcement agencies
Also exempted from individual registration are officials of the Armed Services, Public Health
Service, and Bureau of Prisons, who are also allowed to dispense, administer, and prescribe in the
usual course of their official duties. Other duly authorized law enforcement personnel are exempt
from registration for possession of controlled substances as part of their official duties.

1.15.3 Controlled Substance Registration Application

Pharmacy initially completes application (DEA 224 Application Form). No person may engage in an
activity for which registration is required until application for registration is granted and a certificate of
registration is issued. A registrant can renew online no more than 60 days prior to the current
expiration date by completing a DEA 224a application. If the registrant has not renewed online
approximately 50 days before the registration expiration date, a renewal application is sent to the
registrant at the mailing address listed on the current registration. If the renewal form is not received
by the 30th day before the expiration date of the current registration, the pharmacy should contact
the local DEA Registration Specialist or DEA Headquarters.
 1.15.4 Modification, Termination, and Transfer of Registration
For modifications of registration, (e.g., Change of address, addition of schedules), must notify the
DEA in writing. If approved, the DEA will issue a new certificate, which must be maintained with the
old certificate.
If an individual registrant dies, or if an individual registrant (or corporation) ceases legal existence, or
discontinues business, the DEA must be notified and the registration terminated.
No registration may be transferred or assigned without the approval of the DEA after submitting a
written request. Do not confuse this transfer with the transfer of business activity to another
registrant when a pharmacy goes out of business, for example.

1.15.5 Denial of Registration

The Attorney General may deny a registration to dispense controlled substances if it is determined
that the registration would not be in the public interest.

1.15.6 Revocation or Suspension of Registration

The registration may be suspended/revoked by the Attorney General if the applicant has:
• Materially falsified the application
• Has been convicted of a felony relative to controlled substances
• Has had a state license or registration suspended, revoked, or denied
Before a suspension or revocation, the DEA must first issue an Order to Show Cause upon the
registrant, who then must deliver the Certificate of Registration and all 222 Forms to the DEA, and at
the direction of the DEA, either deliver all controlled substances to the DEA or keep them under seal.
Pharmacies must also provide the DCU with the Federal DEA number within 60 days
of registration.
Separate Registrations are normally required for:

- Manufacturing
- Distributing
- Reverse Distributing
- Dispensing/Instructing
- Research
- Importing
- Exporting
- Narcotic Treatment Program
- Chemical Analyses

Manufacturers, Wholesalers, and Pharmacies in New Jersey must register annually

with the DCU.

Retail pharmacies installing and operating automated dispensing systems at long

term care facilities must maintain a separate registration at the location of each long
term care facility at which automated dispensing systems are located.
 For change of address in NJ, must notify the DCU in writing with date of change; ok
as long as no change in ownership.

In NJ for a corp or partnership, the DCU will consider the change in President or CEO
or a change in ownership of 10% of the outstanding shares. If so, new application
required.

An Order to Show Cause simply means that the DEA is required to provide you an
opportunity to defend yourself and with the Order is asking you to give a good
reason why the DEA should not revoke/suspend your license.

1.16 Controlled Substance Destruction

Any registered practitioner in lawful possession of a controlled substance in its inventory that desires
to dispose of that substance shall do so in one of the following ways:
• Promptly destroy that controlled substance using an on-site method of destruction; (Keep in mind
that this option is only available to pharmacies that have modified DEA registrations that allow them
to be collectors).
• Promptly deliver that controlled substance to a reverse distributor's registered location by common or
contract carrier pick-up or by reverse distributor pick-up at the registrant's registered location;
• For the purpose of return or recall, promptly deliver that controlled substance by common or contract
carrier pick-up or pick-up by other registrants at the registrant's registered location to: The registered
person from whom it was obtained, the registered manufacturer of the substance, or another
registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf;
or
• Request assistance from the Special Agent in Charge of the Administration in the area in which the
practitioner is located.
The request shall be made by submitting one copy of the DEA Form 41 to the Special Agent in
Charge in the practitioner's area. The form is available online
at http://www.DEAdiversion.usdoj.gov
The DEA Form 41 shall list the controlled substance or substances which the registrant desires to
dispose. The Special Agent in Charge shall instruct the registrant to dispose of the controlled
substance in one of the following manners:
• By transfer to a registrant authorized to transport or destroy the substance;
• By delivery to an agent of the Administration or to the nearest office of the Administration; or
• By destruction in the presence of an agent of the Administration or other authorized person.
The DEA form 41 must be used to record the destruction of all controlled substance inventories, as
well as the destruction of controlled substances that are collected from ultimate users.
 1.16.1 Blanket Authorization for Destruction of Controlled
Substances
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 the DEA in each instance, on the condition that the registrant keep records of such disposals and
file periodic reports with the Special Agent in Charge summarizing the disposals made by the
registrant. In granting such authority, the 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.

1.16.2 Reverse Distributors

A pharmacy at any time can forward controlled substances for destruction to a reverse distributor,
which on behalf of the pharmacy can return controlled substances to a manufacturer or dispose of
them.
• The reverse distributor fills out a 222 Form for any schedule II substances that are being destroyed
• The pharmacy records the drug name, dosage form, strength, quantity, and date of transfer for any
CIII through CV substances
• The reverse distributor, not the pharmacy, is responsible for completing the DEA form 41 once the
drugs are destroyed

1.16.3 Summary of DEA Final Rule on Disposal of Controlled

Substances
On September 8, 2014, the Drug Enforcement Administration published the Final Rule for the
Disposal of Controlled Substances, which implements the Secure and Responsible Drug Disposal
Act of 2010. The rule became effective on October 9, 2014. Prior to the passage of the Act, there
were no legal provisions for patients to dispose of unwanted pharmaceutical controlled substances
except to give them to law enforcement, and pharmacies, doctors’ offices, and hospitals were not
allowed to accept them.
The final rule sets requirements for DEA registrants (including pharmacies) that voluntarily decide
to establish disposal programs to collect unwanted controlled substances from ultimate users. The
rule allows numerous DEA registrants to become authorized to establish disposal programs
including manufacturers, distributors, reverse distributors, narcotic treatment programs,
hospitals/clinics with an on-site pharmacy, and retail pharmacies. These persons may
become authorized to have disposal programs by modifying their DEA registrations.
The final rule allows a number of disposal program options including mail-back programs,
collection receptacles, which pharmacies can participate in, and collection events, which are
authorized only for law enforcement (although any person or pharmacy may partner with law
enforcement to hold a collection take back event). Authorized hospitals/clinics and retail pharmacies
may maintain collection receptacles at long-term care facilities. In addition, long-term care facilities
may dispose of controlled substances on behalf of an ultimate user residing or previously residing at
the facility in the collection receptacle maintained by the hospital/clinic or retail pharmacy.
The rule requires destruction of collected controlled substances. It does not require a specific
method but does require that the destroyed substances be rendered non-retrievable i.e. unavailable,
unusable, and not capable of being transformed into a controlled substance. It also sets specific
requirements for process and records for the destruction of collected controlled substances.
The regulations are very detailed regarding these processes and should be read in their entirety for
a complete understanding, especially if a pharmacy is considering becoming a collector.
 A pharmacy would need to have a modified DEA registration and be classified as a
"collector" in order to do on site destruction. In addition, in New Jersey the pharmacy
is required to notify the DCU within 5 days if it becomes a collector, and similarly to
notify the DCU within 5 days of any subsequent change to that status.
If an onsite destruction occurs, 2 employees of the registrant shall handle or observe
the handling of any controlled substance until the substance is rendered non-
retrievable; and 2 employees of the registrant shall personally witness the
destruction of the controlled substance until it is rendered non-retrievable. The
pharmacy shall maintain a record of destruction on a DEA Form 41. The records shall
be complete and accurate, and include the name and signature of the 2 employees
who witnessed the destruction.
Spilled or damaged controlled substances that are recoverable are required to be
destroyed using one of the accepted destruction methods listed and get reported on
a DEA 41 Form; non recoverable controlled substances (e.g., accidentally spilled
down the sink) are simply recorded in the controlled substance records (2 witnesses
needed) but no DEA 41 is completed.

A DEA Form 41 should not be used to record the transfer of controlled substances
between the pharmacy and the reverse distributor disposing of the drugs.

1.17 Controlled Substance Theft or Loss

The registrant shall notify the DEA Field Division Office, in writing, of the theft or significant loss of
any controlled substances within one business day of discovery of such loss or theft. If a
subsequent investigation indicates that a theft or loss has not occurred, then the pharmacist does
not need to complete DEA form 106. 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.
When considering whether a theft or loss is significant, the following factors should be considered:
• The actual quantity of controlled substances missing
• The specific controlled substance missing
• Whether the loss of controlled substance can be associated with access to those controlled
substances by specific individuals, or whether the loss can be attributed to unique activities that may
take place involving those controlled substances
• A pattern of losses over a specific time period, whether the losses appear to be random and the
results of efforts taken to resolve the losses
• If known, whether the specific controlled substances are likely candidates for theft or diversion; and
• Local trends and other indicators of the theft or diversion potential of the missing controlled
substance
However, assuming that there was a confirmed theft or loss, the pharmacy should complete the DEA
106 form related to the theft or loss, which is available online
at http://www.DEAdiversion.usdoj.gov under the heading DEA Forms and Applications. A hard copy
of the DEA 106 form is no longer available for submission. Some of the information required on the
online form includes the name and address of the firm, DEA registration number, date of the theft or
loss, if the police were notified, the type of theft or loss, the items taken or lost including their
estimated value, any identifying symbols or cost codes on the containers, and a list of the missing
items, and the name and title of the person completing the report.
 The DEA recommends that the one business day notification requirement is made by
Fax.

It is up to the professional judgment of the pharmacist as to what constitutes a

"significant" loss. For example, a missing bottle of 100 Phenobarbital would likely
not be viewed as significant, whereas a loss of 3 bottles of 100 of Oxycontin would
be.
In New Jersey, in the event of a significant theft or loss of controlled substances, in
addition to notifying the DEA, a written report must also be filed with the Board of
Pharmacy, which includes a copy of the DEA 106 form. Also, the DCU needs to
receive a copy of the DEA 106 form as well.

1.18 Controlled Substance Prescriptions

A prescription for a controlled substance must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his/her professional practice.The
responsibility for the proper prescribing and dispensing of controlled substances is upon the
prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills
the prescription.

1.18.1 Restrictions
A prescription may not be issued in order for an individual practitioner to obtain controlled
substances for supplying the individual practitioner for general dispensing to patients. Keep in mind
that this does not mean that a prescriber cannot obtain controlled substances from you for
dispensing to patients, but simply that they cannot be ordered on a prescription form. Typically,
Schedule III through V substances would be ordered on an invoice, whereas Schedule II substances
would have to be ordered on a 222 order form completed by the prescriber.
A prescription may not be issued for the dispensing of Methadone for detoxification or maintenance
treatment. However, methadone can be dispensed in a retail pharmacy for analgesic purposes.

1.18.2 Manner of Issuance

All controlled substance prescriptions shall be dated as of, and signed on, the day when issued and
shall bear:
• Full name and address of patient.(If the patient is an animal, the name and address of the owner and
the species of the animal is required).
• Drug name, strength, dosage form, quantity prescribed, directions for use
• Name, address and DEA number of prescriber
• Manual signature of the physician (no signature stamps)

1.18.3 Allowable Changes to a Controlled Substance Prescription

(Schedules III-V)
The pharmacist may:
• Add the patient’s address or change the patient’s address upon verification.
• The pharmacist may change or add the dosage form, drug strength, drug quantity, directions for use,
or issue date only after consultation with and agreement of the prescribing practitioner.
Such consultations and corresponding changes should be noted on the prescription as well as the
patient’s medical record. Pharmacists and practitioners must comply with any state/local laws,
regulations, or policies prohibiting any of these changes to controlled substance prescriptions.
The pharmacist is never permitted to make changes to the patient’s name, controlled substance
prescribed (except for generic substitution permitted by state law) or the prescriber’s signature.

In NJ, prescriptions cannot be written for any amphetamine or sympathomimetic

amine for use in weight management or fatigue

In NJ, all prescriptions for CS, regardless of schedule, shall be presented to the
pharmacist within 30 days after the date when issued.

In NJ, CII CS prescriptions previously were limited to a maximum of a 30-day supply

or 120 dosage units, whichever is less, unless the practitioner follows a treatment
plan designed to achieve effective pain management of a patient suffering from
cancer, intractable pain, or terminal illness. The above provision has now been
changed to "a quantity not to exceed a 30-day supply, which shall be at the lowest
effective dose as determined by the directed dosage and frequency of dosage.”

Pharmacists should follow state law as to whether similar changes can be made to
Schedule II prescriptions. New Jersey does allow similar changes/additions to
Schedule II prescriptions (including adding the DEA number if missing). For
reference consult the July 2014 board newsletter by clicking here.
A computer-generated prescription for a controlled substance that is printed out or
faxed by the practitioner must be manually signed.

1.19 Controlled Drug Prescription Transfer

Generally permissible on a one-time basis only. However, pharmacies electronically sharing a real
time, on-line, database may transfer up to the maximum refills allowed by law.
• The transfer must be communicated between two pharmacists
• The Transferring pharmacist must write:
o "VOID" on the face of the prescription
o Name, address, and DEA of the transferee pharmacy
o Name of the transferee pharmacist
o Date the prescription was transferred
o Pharmacist that transferred the prescription
• The Transferee pharmacist must write:
o "Transfer" on the face of the prescription
o Date of issue of the original prescription
o Original number of authorized refills
o Original date of dispensing
o Number of valid refills remaining and the dates and locations of the previous refills
o Pharmacy name, address, DEA number, and prescription number from which the prescription
information was transferred
o Name of pharmacist who transferred the prescription
o Pharmacy name, address, DEA number, and prescription number from which the prescription
information was originally filled
Note that in New Jersey, the term "Pharmacist" means any pharmacist licensed by
the State of New Jersey to dispense controlled substances and shall include any
other person (for example, a pharmacist intern authorized by the State to dispense
controlled substances under the supervision of a pharmacist licensed by the State).

1.20 Retrieval and Storage of Controlled Substance Refill

Information
If using a manual system, the pharmacist must initial and date the back of the prescription for each
refill. Refills are allowed on substances in Schedules III, IV and V a maximum of 5 times or over a
period of 6 months, whichever comes first, to the extent allowed by the physician.

1.20.1 Computer requirements to be able to store controlled

substance refill information
Alternatively, a computer system may be used for the retrieval and storage of refill information, if it
can provide:
• On-line retrieval of original prescription order information, including original prescription
number, date of issuance of the original prescription, full name and address of the patient, name
address and DEA number of the practitioner, and the name, strength, dosage form, and qty of the
controlled substance prescribed, (and qty dispensed if different), and total number of refills
authorized by the prescriber.
• On-line retrieval of the current refill history of controlled substance prescription orders. The refill
history shall include, but is not limited to, the name of the controlled substance, the date of refill,
quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each
refill and the total number of refills dispensed to date for that prescription order.
• Documentation that any refill information entered in the computer is correct. If the system is
capable, the pharmacist must generate a printout of each day’s controlled substance prescription
refill data, verify, date, and sign it.The printout must be provided within 72 hours of the time the refill
was dispensed. If there is no printout capability, then the pharmacist must sign a logbook or
separate file each day, verifying the accuracy of the refill information by the pharmacist.
• Capability of printing out refill information (e.g. 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). The
printout must include the name of the prescribing practitioner, name and address of the patient,
quantity dispensed on each refill, date of dispensing for each refill, name or identification code of the
 dispensing pharmacist, and the number of the original prescription order. If using central record
keeping to store this information, must be able to provide this printout within 48 hours.
• Auxiliary procedure to document refills in the event of system downtime. This auxiliary
procedure must insure that refills are authorized by the original prescription order; that the maximum
number of refills has not been exceeded, and that all of the appropriate data is retained for on-line
data entry as soon as the computer system is available.

1.20.2 Additional Refills for Controlled Substance Prescriptions

The practitioner may authorize additional refills of Schedule III-V through an oral refill authorization
provided that:
• Total quantity authorized, including that on the original does not exceed five refills nor extend
beyond six months from the date of issue
• The pharmacist initials and records the date, quantity authorized, and number of additional refills
authorized on the reverse of the original prescription
• The quantity of each additional refill is equal to or less than the quantity authorized for the initial
filling
Note the difference in NJ law related to additional refills in the text box to the right.

In New Jersey, there is a 5 year retention requirement on the controlled substance

refill data verification, whether it is generated by a computer printout or captured in a
log book.

in New Jersey additional quantities of controlled substances may only be authorized

by a prescribing practitioner through the issuance of a new prescription which shall
be a new and separate prescription.

1.21 Inspections Under the CSA

Before an inspection, the inspector is required to:
• State the purpose of the inspection
• Present credentials, and
• Provide a written Notice of Inspection
However, if a Search Warrant is served on the pharmacist, it cannot be refused.
• Normally a search warrant is issued only when a law enforcement officer convinces a judge that a
crime has been or will be committed and that relevant evidence exists at the site to be inspected
Similarly, an Administrative Inspection Warrant cannot be refused
An AIW is similar to a search warrant, but one important difference is that a judge will issue an AIW
given a probable cause of serving " a valid public interest"
The pharmacist has a right to refuse the inspection or withdraw consent at any time
during the inspection when only a Notice of Inspection is served
 A "valid public interest" can simply be that a period of time has elapsed since the last
inspection or that the pharmacy is ordering more CS than a similar pharmacy. The
bottom line is that it is much easier for an inspector to obtain an AIW than a search
warrant.

1.22 Mailing of Controlled Substances

The United States Postal Regulations formerly allowed only prescription medicines containing non-
narcotic controlled substances to be mailed from a practitioner or dispenser to an ultimate user. The
regulations have been amended to allow the mailing of narcotic controlled substances.

1.22.1 Special Requirements for Mailing

• Must be placed in a plain outer mailing container or securely over-wrapped in plain paper
• The inner container must also be labeled to show the prescription number and the name and
address of the pharmacy, practitioner, or other person dispensing the prescription
• The outer mailing wrapper or container is free of markings that indicate the nature of the content

1.23 Facsimile Prescriptions

Faxing of CII prescriptions is allowed. However, before dispensing a faxed CII prescription, the
pharmacist must generally receive the original signed Rx for review, except for a faxed prescription
for:
• A schedule II to be compounded for direct administration to a patient by parenteral, intravenous,
intramuscular, subcutaneous, or intra-spinal infusion
• A schedule II narcotic for a hospice patient
• Any scheduled II substance for a patient in a long term care facility
CSA regulations also permit faxed prescriptions for C III-V (and non-controlled
substances) to serve as original prescriptions

In New Jersey, there are some subtle differences in this area. For all 3 exceptions
noted in this section, the faxed prescription has to be for pain management. Also,
for the faxed CII for a hospice patient, the practitioner or agent needs to write on the
fax that it is for a hospice patient.

1.24 Methadone (Dolophine) Dispensing

A pharmacist can dispense Methadone in a retail setting for analgesic purposes only. For addicts,
treatment with Methadone is only allowed in a Methadone Clinic with the following exceptions:
• Dispensing by a physician over a 3-day period while in the process of enrolling a patient in a
clinic. Note that this would occur in the context of the physician's office and a prescription would not
be issued.
• Administering to a patient while hospitalized for a condition unrelated to the addiction
• For intractable pain (e.g., terminal cancer patient)
Only the physician or an RN, LPN, or R.Ph or any other healthcare professional
authorized by Federal and State law to administer or dispense opioid drugs operating
under the direction of the physician can administer Methadone at a clinic.

1.25 Opiate Treatment Programs

The Narcotic Addict Treatment Act of 1974 required practitioners who wished to
conduct maintenance or detoxification treatment for addicts using controlled substances to do so
only by being separately registered by the DEA as narcotic treatment programs ( NTPs). Only
methadone, levo- alpha- acetyl- methadol (LAAM), buprenorphine sublingual, and buprenorphine-
naloxone are approved for the treatment of narcotic addiction in these treatment programs.
In May 2001 a new regulation repealed FDA regulations, transferred enforcement to Center for
Substance Abuse Treatment (CSAT) within the Substance Abuse and Mental Health Services
Administration (SAMHSA), and changed the name of the treatment programs from narcotic
to opioid treatment programs ( OTPs). The regulation created an entirely new system whereby
practitioners intending to treat opioid addiction must apply for a certification certification by CSAT as
well as the applicable state methadone authority. Certification is determined by an accreditation
body that evaluates whether the OTP meets the required standards.
Overall, then, practitioners wishing to prescribe and dispense methadone for maintenance and
detoxification treatment in an Opiate Treatment Program must obtain both a registration and a
certification, namely a DEA registration as a Narcotic Treatment Program, and the above-
referenced certification from CSAT and the applicable state authority.

1.25.1 Applicable Definitions

The term “detoxification treatment” means: the dispensing of an opioid agonist treatment
medication in decreasing doses to an individual to alleviate adverse physiological or psychological
effects incident to withdrawal from the continuous or sustained use of an opioid drug and as a
method of bringing the individual to a narcotic drug- free state within such period. There are two
types of detoxification treatment, short-term detoxification treatment and long-term detoxification
treatment:
• Short-term detoxification treatment is for a period not in excess of 30 days
• Long-term detoxification treatment is for a period more than 30 days but not in excess of 180
days
The term “maintenance treatment” means: the dispensing of an opioid agonist treatment
medication at stable dosage levels for a period in excess of 21 days, in the treatment of an
individual for opioid addiction.

1.26 Office-Based Addiction Treatment

The Drug Addiction Treatment Act (DATA) of 2000 expanded the treatment of opiate addicts
beyond the clinic, in that it allows the use of Buprenorphine (Subutex)
and Buprenorphine & Naloxone (Suboxone) to be dispensed in a retail pharmacy for the treatment of
 opiate addiction. Subutex is typically used for initial treatment and Suboxone is used for
maintenance treatment.
Qualified Physicians can write prescriptions for Subutex or Suboxone. Qualified Physicians are
given a DEA number in addition to their regular DEA number. For example, if the physician’s regular
DEA number were AB 9787079, then the additional DEA, which allows prescribing
of Buprenorphine, would be XB 9787079. In order to be qualified to prescribe Buprenorphine, a
physician must have a certification in Addiction Medicine, or have completed 8 hours of specified CE
requirements. In addition, physicians are initially limited to 30 active patients (but may request to
treat up to 100 after 1 year) and must have the capacity to refer patients for necessary ancillary
services (e.g., psychosocial therapy). Pharmacists may inquire if a physician is qualified to write
for Buprenorphine, by calling 1-866-BUP-CSAT; e-mailing info@buprenorphine.samhsa.gov; or by
checking the SAMHSA web site. Physicians who have prescribed buprenorphine to 100 patients for
at least one year can now apply to increase their patient limits to 275 under new federal regulations.
In addition to the requirements to be a qualified physician, a practitioner also needs to request a
waiver from CSAT, which then notifies DEA of all waiver requests. Practitioners who receive a
waiver are referred to as DATA waived practitioners.
Subutex and Suboxone are Schedule III Controlled Substances

1.27 Storage of Controlled Drugs

Controlled drugs may be stored in a secure, substantially constructed locked cabinet, or may be
dispersed throughout the stock in such a way as to obstruct theft or diversion.
Some pharmacies make it a practice to lock up Schedule II substances. Keep in mind that this a
legitimate precaution to take, but it is not a federal or state requirement.

1.28 Emergency Kits

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:

• 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.
• 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.
• 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.
• 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 and
in compliance with the provisions of 21 C.F.R. §§ 1306.11 and 1306.21.
• 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.
1.29 Labeling Requirements for Commercial Packages of
Controlled Substances
Each commercial container of a controlled substance shall have printed on the label the symbol
designating which schedule the controlled substance is listed. The symbol shall be prominently
located on the label or the labeling of the commercial container, and shall be large enough to afford
easy identification of the schedule of the controlled substance upon inspection without removal from
the dispenser’s shelf. (note the more stringent requirements in New Jersey in the text box).
Additionally, NJ requires the symbol to be located in the upper right- hand corner at
least 2 times as large as the largest type printed on the label, or overprinted on the
label half the height of the label.

1.30 Sealing of Controlled Substances

On each commercial container of any controlled substance, there shall be securely affixed to the
stopper, cap, lid, covering, or wrapper a seal to disclose upon inspection any tampering or opening
of the container.
Note the requirement in New Jersey which seems to limit the requirement for a seal.
"On each bottle, multiple dose vial, or other commercial container of any controlled
substance in schedule I or II, or any other narcotic controlled substance in Schedules
III-V, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper a
seal to disclose upon inspection any tampering or opening of the
container." Considering that the federal requirement in the main body of the text
requires a seal for all controlled substances, the federal law will prevail.

1.31 Verifying Legitimacy of a DEA Number

Add the second, fourth, and sixth digits. Then double that amount.
To this subtotal, add the first, third, and fifth digits.
The last digit of the total should correspond with the last digit of the DEA number.
For example, for the DEA number 1234563, add the second, fourth, and sixth digit (2 +4 +6 X
2 =24)
Add this sum to the total of the first, third, and fifth digits (24 + 1+3+5=33)
The last digit in this total corresponds to the last digit 3 in the DEA number 1234563
Keep in mind that if you are using the formula above to check a DEA number, and the last digit in the
total corresponds the last digit in the DEA number, that all you have proven is that you have a
potentially correct DEA number. The only way to know for sure if the DEA number is legitimate is to
check the DEA database.
Due to the large Type A (Practitioner) registrant population, the initial alpha letter
"B" has been exhausted. DEA has begun using the new alpha letters "F"and "G" as
the initial character for all new registration for Type A (Practitioner)
Wholesaler DEA numbers begin with a P or an R, whereas mid-level practitioner DEA
numbers begin with the letter M.
 1.32 Controlled Substance Prescription Label
The controlled substance prescription label in New Jersey must contain:
• The pharmacy name and address
• The pharmacy telephone number
• The brand name, or if a generic, the brand name and the name of the generic in the following form,
with the generic name and brand name inserted as appropriate: "--------- Generic for ---------"
• The strength of medication, where applicable
• The quantity dispensed
• The date upon which prescription medication is dispensed
• A CDS cautionary label
• The patient name
• The practitioner's name
• The prescription number
• Directions for use; and
• The phrase "use by" followed by the product's use by date, if dispensed in any packaging other than
the manufacturer's original packaging (i.e., the earlier of one year from the date of dispensing or the
expiration date on the manufacturer's container)

1.32.1 Controlled Substance Prescription Label (Central Fill)

For any prescriptions filled at a central fill pharmacy, the central fill pharmacy shall affix a label
showing:
• The retail pharmacy name and address, and
• A unique identifier (i.e., the central fill pharmacy’s DEA number indicating that the prescription
was filled at the central fill pharmacy)

The patient name, the brand or generic name of the medication, and the directions for
use shall appear in larger type, in a different color type, or in bolded type, in
comparison to the other information required to appear on the label

Normal labeling requirements for controlled substances, including the caution

statement, are waived for institutional patients if: Schedule II drug is dispensed in NMT a
7 day supply, or Schedule III-V drug is dispensed in a 34 day supply or 100 unit doses,
whichever is less, and the drug is not in possession of the ultimate user prior to
administration and other appropriate safeguards are instituted

1.33 Central Filling of Controlled Substances

The concept of central filling is a fairly simple one. It involves more than one pharmacy being
involved in the filling of a prescription. The simplest example is a pharmacy who receives a
prescription from a patient, which is then forwarded to another pharmacy (i.e., a central fill)
pharmacy, which actually fills the prescription and then returns it to the pharmacy that originally
accepted the prescription. The DEA permits this process for the filling of controlled substances if the
following requirements are met.
 1.33.1 Transmitting Pharmacy Requirements
Prescriptions may be transmitted electronically from the retail (transmitting) pharmacy to the central
fill pharmacy. The transmitting pharmacy must write “central fill” pharmacy on the face of the
prescription and record the name, address, and DEA number of the central fill pharmacy; the name
of transmitting pharmacist; and date of transmission.
The transmitting pharmacy must also keep a record of receipt of the filled prescription, including the
date of receipt, method of delivery and the name of the employee accepting delivery.

1.33.2 Central Fill Pharmacy Requirements

The central fill pharmacy must keep a copy of the prescription if sent by fax or an electronic record of
the information sent, including name, address, and DEA number of the transmitting pharmacy. The
central fill pharmacy must also keep a record of the date of receipt of the transmitted prescription,
the name of the pharmacist filling the prescription, and the date of filling. Must also keep a record of
the date delivered to the retail pharmacy and the method of delivery.

1.34 Veterinary Prescribing

A veterinarian may prescribe, administer, or dispense a controlled substance, other drug or device
only:
• In good faith in the course of his professional practice
• Not for use by a human being
Be alert for scenarios on the exam whereby a physician is attempting to write a
prescription for an animal or a veterinarian is attempting to write a prescription for a
human—neither of which is permissible.

A prescription written for a controlled substance for an animal would not list the
animal's name but rather the species of the animal and the name and address of the
owner.

1.35 Controlled Substance Registration Protection Act

Was enacted to protect DEA registrants such as pharmacies and mandates that a federal
investigation result if any of the following occur:
• Replacement cost of Controlled Substances taken is $500 or greater
• Registrant or other person is killed or suffers significant injury
• Interstate or foreign commerce is involved in the planning or execution of the crime

Penalties Upon Conviction:

Burglary or robbery - a maximum $25,000 fine and/or 20 years imprisonment.

If a dangerous weapon was used to carry out the crime - a maximum $35,000 fine
and/or 25 years imprisonment.
 If death resulted from the crime - a maximum $50,000 fine and/or life imprisonment.

Examples of interstate commerce would be if a robbery was planned in New Jersey

for example, and carried out in Pennsylvania, or if a robbery was carried out in
Pennsylvania and the perpetrators fled across state lines to New Jersey

1.36 Distribution of Controlled Substances upon

Discontinuance of a Business
1.36.1 When not transferring the business activity
When a registrant wishes to discontinue a business and not transfer it to another person, the
registrant must return the certificate of registration together with any unused 222 forms to the DEA at
the Washington DC office. The registrant must also complete a DEA 41 Form and wait for response
on how to dispose of controlled substances.

1.36.2 When transferring the business activity

When a registrant wishes to discontinue a business and transfer it to another person, the registrant
must submit the proposal to the DEA 14 days in advance and include:
• Name, address, and DEA number of the registrant discontinuing the business and well as the same
information for the registrant acquiring the business
• Whether the business activities will continue at the current location or at another location
Unless the DEA says no, the transfer can occur, and on the day of the transfer, a complete
controlled substance inventory must be taken (transfer of CIIs must be done through the use of the
222 Form). The controlled substance records are also transferred
In New Jersey, the state certificate of registration get returned to the DCUwithin 10
days.

You must also similarly notify the DCU of proposed transfer date 14 days prior along
with the name, address, State CDS and Federal DEA # of transferor and transferee
(same requirements apply for any registrant receiving Rx files).
Also, must report the name & address of the person or firm who will maintain
invoices, & executed order forms of the discontinued business for period not less
than 2 years.

1.37 Miscellaneous Controlled Substance

Considerations
• No DEA registrant may employ an individual who has access to controlled substances if that
individual had previously been convicted of a felony offense related to controlled substances or, who
at any time, had an application for CS registration denied, revoked, or surrendered for
cause. Individuals who find themselves in this situation do have the option of requesting a waiver
from the DEA from this prohibition.
• A state law or regulation can be stricter than its federal counterpart as long as it doesn’t conflict

1.38 Combat Methamphetamine Epidemic Act

On March 9, 2006, President Bush signed into law the Combat Methamphetamine Epidemic Act.
Listed below is a summary of the key requirements governing the retail sale of all cough and cold
products that contain the methamphetamine precursor chemicals ephedrine, pseudoephedrine or
phenylpropanolamine, collectively referred to Scheduled Listed Chemical Products (SLCP's). For all
intents and purposes, phenylpropanolamine has been withdrawn from the market and is no longer at
issue.

1.38.1 Sales Limits

Daily Sales Limit on Retailers: Retail sales may not exceed 3.6 grams (base) per day per
purchaser, regardless of the number of transactions.
30-Day Purchase Limit on Consumers: Individuals are prohibited from purchasing more than 9 g
(base) per 30-day period.
Mail Order Limits: Mail order companies may not sell more than 7.5 grams (base) to a customer
within a 30-day period. Mail order sales are not subject to the logbook, training or certification
requirements listed below, although the seller does need to obtain identification as required below.

1.38.2 Other Restrictions

Behind-the-Counter Placement: All SLCP products must be placed behind a counter that is not
accessible to purchasing consumers or in a locked display case that is located on the selling floor.
Logbook: Retailers must maintain a written or electronic logbook of information on transactions
involving SLCP products. The logbook may be maintained in either written or electronic form. The
purchaser signs the logbook and enter name, address, and date/time of sale. Obviously, some
retailers capture the name, address, and date/time of sale automatically with a card swipe. The
retailer then checks the information entered by purchaser against photo ID and enters the name of
product sold and quantity. Logbook requirements do not apply to purchases of single sales
packages that contain no more than 60 mg of pseudoephedrine.
False Statements Notice: The written or electronic logbook must also include the following notice:
WARNING: Section 1001 of Title 18, United States Code, states that whoever, with respect to the
logbook, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device a
material fact, or makes any materially false, fictitious, or fraudulent statement or representation, or
makes or uses any false writing or document knowing the same to contain any materially false,
fictitious, or fraudulent statement or entry, shall be fined not more than $250,000 if an individual or
$500,000 if an organization, imprisoned not more than five years, or both.
2-Year Retention Period: Each entry must be maintained for two (2) years following the date of
entry.
Photo ID: In conjunction with the logbook requirement, retailers will be required to ask for photo
identification, issued by either a State or the Federal Government or other appropriate
identification. For a list of alternate forms of identification acceptable under 8 C.F.R. §§
274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B). You may be surprised to note that even a report card is
listed as one of the acceptable alternative forms of identification.

1.38.3 Training and Employees

Training & Certification: Retailers must train applicable sales personnel to ensure that they
understand the requirements of SLCP product sales and submit self-certifications to the Attorney
General in this regard. The self certification must be updated on an annual basis. Retailers must
also maintain certifications and records to confirm employee training.
Consequences: The Attorney General may prohibit persons who sell products in violation of the
sales restrictions or the logbook, training, and certification requirements from selling any scheduled
listed chemical products.
Job Applicant Screening: Retail stores may take reasonable measures to guard against employing
individuals who may present a risk with respect to the theft and diversion of SLCP products,
including asking job applicants whether they have been convicted of any crime involving or related to
SLCP products or controlled substances.
Remember to calculate the allowable quantities based on the amount of BASE in the
product: For example, in a 25 mg Ephedrine HCl tablet there is 20.57 mg. of
base; Similarly, there is 24.65 mg of base in a 30 mg Pseudoephedrine HCl
tablet; and there is 23.22mg of base in a 30 mg Pseudoephedrine SO4 tablet.

A good rule of thumb to remember is that you can purchase 146 tablets per day of
Sudafed 30mg (Pseudoephedrine HCL). How do you know this? Well, if someone can
purchase 3.6 gms of base/day, that would be 3,600 mg. But you should not divide
this by 30 mg and get 120 tablets as a maximum/day quantity. You need to divide
3,600 mg by 24.65 (i.e. the amount of base/tablet) and the result is 146 tablets.

Note that under federal law or New Jersey law, there is no specific age requirement to
purchase an SLCP product, although other states do sometimes impose an age
requirement.

Any loss or disappearance of a scheduled listed chemical product (e.g. Sudafed)

must be reported to the DEA orally ASAP, and then followed up with a written report
within 15 days.

1.39 Issuance of Multiple Prescriptions for Schedule II

Controlled Substances
An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total
of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are
met:
• Each separate prescription is issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of professional practice;
• The individual practitioner provides written instructions on each prescription (other than the first
prescription, if the prescribing practitioner intends for that prescription to be filled immediately)
indicating the earliest date on which a pharmacy may fill each prescription;
• The individual practitioner concludes that providing the patient with multiple prescriptions in this
manner does not create an undue risk of diversion or abuse;
• The issuance of multiple prescriptions as described in this section is permissible under the
applicable state laws; and
• The individual practitioner complies fully with all other applicable requirements under the Act and
these regulations as well as any additional requirements under state law.
The statutory authority to issue such prescriptions, however, applies only to
physicians. All other prescribers in NJ, including advance practice nurses and
physician assistants, are precluded from issuing multiple Schedule II prescriptions to
a patient for a 90-day supply.

Keep in mind that in New Jersey, controlled substance prescriptions must normally
be presented for filling within 30 days and are limited to a 30 days supply. NJ law
and regulations have been modified to allow the 90 days supply via multiple
prescriptions. However, they still need to be filled within 30 days of when they are
allowed to be filled.

New Jersey also limits the number of multiple prescriptions to 3 (i.e., one Rx for an
immediate 30-day supply and 2 additional Rx's for the subsequent 2 months).

1.41 Agents of the Prescriber

The DEA recently announced a policy whereby a prescriber may authorize a nonemployee agent to
transmit a prescription for a controlled substance to a pharmacist. Traditionally, nurses and other
employees working in a LTCF had been transmitting physician orders to pharmacies, and the DEA
took a hard line stance on this practice since these individuals were not authorized agents of the
physician. The newly announced DEA policy relaxes this hard line stance and creates a vehicle
(i.e., written agent agreement) for individuals acting outside of an employer/employee relationship to
be considered agents of the prescriber. The DEA provides a sample agent agreement in the
Federal Register (Volume 75; No. 193; October 6, 2010; 61613). You can view a copy by
clicking here.
According to the policy, following is a list of activities in which an authorized agent of the prescriber
may engage:
• •Prepare a controlled substance prescription for the signature of the prescriber
• •Orally communicate a prescriber's C-III, C-IV, or C-V prescription to a pharmacist or via practitioner-
signed fax
• •Transmit by fax a prescriber's written C-II prescription to a pharmacist for a patient in hospice or
LTCF
 Emergency oral communication of C-II prescription may not be delegated to an authorized
agent
DEA recommends that the original signed agency agreement be kept by the practitioner during the
term of the agency relationship and for a reasonable period after termination or revocation. A signed
copy should also be provided to the practitioner's designated agent, the agent's employer (if other
than the practitioner), and any pharmacies that regularly receive communications from the agent
pursuant to the agreement.

1.42 CV Retail Sales

Some schedule V substances may be sold OTC, if they are not a prescription by federal law and
permitted by state law, if:
• The sale is done by a pharmacist
• The purchaser must be at least 18 yrs. of age and must either be known to the pharmacist or have
suitable identification
• No more than 8 ounces or 48 dosage units of any substance containing Opium in any 48 hr
period may be provided to the purchaser
• No more than 4 ounces or 24 dosage units of any other controlled substance may be provided to the
purchaser in any 48-hour period.
• The name and address of the buyer, the name and quantity of the item, the date, and the signature
or the initials of the pharmacist are recorded in a bound record book
NJ also permits retail CV sales to be made by the pharmacy intern under the
supervision of the pharmacist.

Under federal law, the record book must be maintained for 2 years; New Jersey law
requires that the CV record book be maintained for 5 years

CV OTC sales are discussed in more detail in the Drug Dispensing and Prescription
Records section. That section describes the requirements for when an individual is
making multiple purchases, and you should be very familiar with those requirements
for purposes of the MPJE exam.

1.43 Prescription Monitoring Program

New Jersey has recently implemented a Prescription Monitoring Program. The NJPMP is a
statewide database that collects prescription data on Controlled Dangerous Substances (CDS) and
Human Growth Hormone (HGH) dispensed in pharmacies in New Jersey, and by out-of-state
pharmacies dispensing into New Jersey.
Pharmacists are required to report CS prescription information daily, or no more than one
business day after a CS was dispensed. Prescribers must consult the PMP the first time they
prescribe a Schedule II CS to a patient for acute and chronic pain, and quarterly thereafter for
patients who continue to receive such medications. Pharmacists will be required to consult the state
PMP before dispensing a Schedule II CS if they believe the patient may be seeking the prescription
 for any use other than medical treatment. Pharmacists must also submit identifying information for
anyone who picks up a controlled substance prescription on behalf of another patient if abuse or
misuse is suspected.

1.43.1 Access by Prescribers and Pharmacists

Access to the NJPMP is granted to prescribers and pharmacists who are licensed by the State of NJ
and in good standing with their respective licensing boards.
Before issuing a prescription or dispensing a prescribed drug, qualified prescribers and pharmacists
who have registered to use the NJPMP are able to access the NJPMP website and request the CDS
and HGH prescription history of the patient. The users must certify that they are seeking information
for a specific, current patient.
Patient information in the NJPMP is intended to supplement an evaluation of a patient, confirm a
patient’s drug history, or document compliance with a therapeutic regimen. When prescribers or
pharmacists identify a patient as potentially having an issue of concern regarding drug use, they are
encouraged to help the patient locate assistance and take any other action the prescriber or
pharmacist deems appropriate.

1.43.2 Patient Privacy

The New Jersey Division of Consumer Affairs and its private contractor that operates the database
keep NJPMP patient information strictly confidential, in compliance with the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules.
Prescribers and pharmacists authorized to access the NJPMP, must certify before each search that
they are seeking data solely for the purpose of providing healthcare to current patients. Authorized
users agree that they will not provide access to the NJPMP to any other individuals, including
members of their staff.
A prescriber or pharmacist who accesses or discloses NJPMP information for any purpose other
than providing healthcare to a current patient or verifying the NJPMP’s record of prescriptions issued
by the prescriber, or who allows any other individuals to access the NJPMP using the prescriber’s or
pharmacist’s own access codes, is subject to civil penalties of up to $10,000 for each offense and
disciplinary action by the prescriber’s or pharmacist’s professional licensing board.

1.43.3 Non-Provider Access to Data

Designated representatives of the State's Medicaid program, as well as designated representatives
of any State board – of this or any other state – that regulates the practice of persons authorized to
prescribe or dispense CDS, may be granted access to prescription monitoring information upon
presenting a certification that the representative is engaged in a bona fide investigation of a
designated practitioner or patient.
Federal, state, and municipal law enforcement may be granted access to prescription monitoring
information in two ways: (1) pursuant to a court order for the information, accompanied by a
certification from the officer that he or she is engaged in a bona fide, specific investigation of a
designated practitioner or patient; and (2) through a properly convened grand jury, pursuant to a
grand jury subpoena properly issued for the records.

1.43.4 Pharmacy Reporting Requirements

• The surname, first name, and date of birth of the patient
• The street address and telephone number of the patient
• The date that the medication is dispensed
• The prescription number and the National Drug Code of the drug dispensed
• The pharmacy permit number
• The prescribing practitioner's name and DEA number
• The name, strength, and quantity of the drug dispensed, the number of refills ordered
• Whether the drug was dispensed as a refill or a new prescription
• The date that the prescription was issued by the practitioner
• The source of payment for the drug dispensed

The rules related to the prescription monitoring program also apply to out of state
pharmacies that are registered with the State Board of New Jersey.

The PMP reporting requirements do not apply to any controlled substance or human
growth hormone prescriptions filled by a pharmacy for an inpatient at a hospital,
long term care facility, or any other facility where there is 24 hour nursing care.

The pharmacy shall establish, retain, and follow written procedures to document, any
required or non-required PMP look-up.

1.44 Take Back Programs

Effective January 1, 2016, prescribers and pharmacies are required to provide a notice about
drug take back programs upon dispensing to each patient a (CDS) prescription
medication. Pharmacies are required to distribute (other than LTCF pharmacies) a notice
prepared by the Division of Consumer Affairs informing them of the location of 24x7 drop-off
locations.

1.45 Naloxone Dispensing

1.45.1 Guidance for Pharmacists Dispensing Naloxone
On May 2, 2013, Governor Chris Christie signed into law the Overdose Prevention Act (P.L. 2013,
c. 46, N.J.S.A. 24:6J-1 et seq.). This act was amended on February 5, 2015. One of the purposes of
the law is to reduce the number of opioid overdose deaths by making naloxone, an opioid antidote,
more widely available and accessible. The statute allows health care professionals to prescribe or
dispense naloxone, or similarly acting drugs, not only to patients who may be in danger of
overdosing, but also to first responders, family members, caregivers, or peers who are not at risk for
an opioid overdose but who are deemed capable of administering the antidote to an overdose victim
in an emergency.

1.45.2 Dispensing Naloxone via a Patient-Specific

Prescription
When presented with a prescription for Naloxone, the pharmacist should:
• Ask if the prescription is for use by the person whose name is on the prescription
• Document on the prescription that the question was asked along with the answer
• If the prescription is for the end user, then fill as any usual prescription, including the offer of
counseling
• If the prescription is for a person who is deemed capable of administering the antidote to an
overdose victim in an emergency, set up a separate file and do not process through insurance
 1.45.3 Dispensing Naloxone via a Physician’s Standing
Order
A pharmacist directly or through a standing order may dispense an opioid antidote to any recipient
who is deemed by the pharmacist to be capable of administering the opioid antidote to an overdose
victim in an emergency. A pharmacist may dispense Naloxone pursuant to a specific valid standing
order to “emergency medical responders” and other “professionals” (eg, emergency medical
technicians, those employed by the criminal justice system, addiction professionals, “professional
entities”) who are acting in their regular course of business. Please review the complete text of the
law for details outlining the requirements of standing orders and those authorized to receive opioid
antidotes through a standing order. Overall, it appears that there are limitations as to whom a
pharmacy may dispense Naloxone per a standing order, as opposed to a prescription.

1.45.4 Dissemination of Overdose Prevention Information

The pharmacist must document that overdose prevention information was provided to the antidote
recipient regardless of the method used to obtain the medication. The requisite overdose prevention
information shall include, but is not limited to:
• Information on opioid overdose prevention and recognition
• Instructions on how to perform rescue breathing and resuscitation
• Information on opioid antidote dosage and instructions on opioid antidote administration
• Information describing the importance of calling 911 emergency telephone service for assistance
with an opioid overdose and
• Instructions for appropriate care of an overdose victim after administration of the opioid antidote
Pharmacies are required to document the dissemination of overdose prevention information and the
contact information for the persons receiving such information, to the extent known, in the patient’s
medical record, if applicable, or another appropriate record or log, if the patient’s medical record is
unavailable or inaccessible, or if the antidote recipient is a professional or professional entity acting
in their professional capacity

1.46 Limitations on Opioid Prescribing and

Dispensing
1.46.1 Background
On February 15, 2017, P.L. 2017, c.28 was signed into law, and sets forth steps a practitioner must
take when prescribing,dispensing, or administering a controlled dangerous substance. The
amendments establish special requirements when prescribing a Schedule II controlled dangerous
substance for pain or any opioid drug; for the treatment of chronic pain; and the prescribing
of opioid drugs for the treatment of acute pain.

When determining whether a patient was previously issued a prescription

for a drug or its pharmaceutical equivalent,the practitioner shall consult
with the patient, review prescription monitoring information, and, to the
extent it is available to the practitioner, review the patient’s medical record.

1.46.2 Definitions:
"Initial prescription" means a prescription issued to a patient who:
• Has never previously been issued a prescription for the drug or its pharmaceutical equivalent or
• Was previously issued a prescription for the drug or its pharmaceutical equivalent, and the date on
which the current prescription is being issued is more than one year after the date the patient last
used or was administered the drug or its equivalent
"Practitioner" means an individual currently licensed, registered, or otherwise authorized to prescribe
drugs in the course of professional practice, to include a physician, a podiatrist, a physician
assistant, and a certified nurse midwife, acting within the scope of practice of his or her
professional license or certification.

1.46.3 Prescribing
Prior to issuing the first prescription for a Schedule II controlled dangerous substance for pain or any
opioid drug, and then again prior to issuing the third prescription, the practitioner must discuss with
the patient the reasons why the medication is being prescribed, the possible alternative treatments,
and the risks associated with the medication. With respect to opioid drugs, the discussion must also
include the risks of addiction, physical or psychological dependence, and overdose associated with
opioid drugs, the danger of taking opioid drugs with alcohol, benzodiazepines and other central
nervous system depressants, and the requirements for proper storage and disposal. The practitioner
is required to include a note in the patient record that this discussion took place.
When the patient is under 18 years of age and is not an emancipated minor, the above discussion is
with, and the written acknowledgement is from, the patient’s parent or guardian. With respect to the
treatment of minors, if the prescription is for an opioid drug which is a Schedule II controlled
dangerous substance, the practitioner shall have the required discussion prior to the issuance of
each prescription, and shall include a note in the patient record that the discussion took place.

1.46.4 Pain Management Agreements

Practitioner are required to enter into a pain management agreement with a patient when issuing the
third prescription for a Schedule II controlled dangerous substance for pain or any opioid drug. The
pain management agreement must:
• Be signed and dated by the practitioner and patient prior to the issuance of the third prescription for
the ongoing treatment of pain using a Schedule II controlled dangerous substance or any opioid drug
• Document the understanding of both the practitioner and the patient concerning the patient’s pain
management plan;
• Establish the patient’s rights in association with treatment, and the patient’s obligations in relation to
the responsible use, discontinuation of use, storage and disposal of Schedule II controlled
dangerous substances and any opioid drugs, including any restrictions on the refill of or the
acceptance of such prescriptions from other practitioners or prescribers
• Identify the specific medications and other modes of treatment that are included as part of the
treatment plan
• Specify the measures the practitioner may employ to monitor the patient’s compliance, such as
random specimen screens and pill counts;
• Delineate the process for terminating the agreement, including the consequences if the practitioner
has reason to believe that the patient is not complying with the terms of the agreement

1.46.5 Initial Prescriptions for Opioids

An initial prescription for an opioid drug for treatment of acute pain shall not exceed a five-
day supply, as determined by the directed dosage and frequency of dosage. The initial prescription
shall be for the lowest effective dose of an immediate release opioid drug. The rule further provides
that a practitioner shall not issue an initial prescription for an opioid drug that is for an
extended-release or long-acting opioid. No less than four days after issuing the initial prescription,
upon request of the patient, a practitioner may issue a subsequent prescription for an opioid drug for
the continued treatment of acute pain associated with the condition that necessitated the initial
prescription.
Prior to issuing the subsequent prescription the practitioner must consult with the patient. The
consultation may be in person, via telephone, or via other means of direct communication. After the
consultation, the practitioner, in the exercise of professional judgment, must determine that an
additional days’ supply of the prescribed opioid drug is necessary and appropriate to the patient’s
treatment needs, and does not present an undue risk of abuse, addiction, or diversion. The
practitioner is required to document the rationale for the authorization in the patient
record. Subsequent prescriptions for an additional days’ supply of the prescribed opioid drug
must be tailored to the patient’s expected need at the stage of recovery, and in no case may
the quantity exceed a 30-day supply, (exception for implantable infusion pump or multiple CII
prescriptions issued at the same time). The proposed amendments do not change the existing rules
regarding emergency dispensing of CII prescriptions.

1.46.6 Exceptions
The requirements for prescribing controlled dangerous substances do not apply to a prescription for
a patient who is currently in active treatment for cancer, or receiving hospice care from a licensed
hospice, or is receiving palliative care, or is a resident of a long-term care facility, or to any
medications that are being prescribed for use in the treatment of substance abuse or opioid
dependence.
 2. FOOD DRUG & COSMETIC ACT AND
RELATED REGULATIONS
The FD&C Act of 1938 together with subsequent amendments regulates drug quality. Under the
1938 FD&C Act, no new drug could be marketed until proven safe for use under the conditions
described on the label and approved by the FDA. The FD&C Act also required labels to
have adequate directions for use.

2.1 Definition of Drug

The FD&C Act defines the term drug as:
▪ (a) articles recognized in the official USP, Homeopathic Pharmacopoeia of the US, or the NF, or any
supplement to any of them; and
▪ (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, in
man or other animals; and
▪ (c) articles (other than food) intended to affect the structure or any function of the body of man or
other animals; and
▪ (d) articles intended for use as a component of any article specified in clause (a), (b), or (c); but does
not include devices or their components, parts, or accessories.

Generally, if a product is marketed as a drug (i.e., with intent to diagnose, cure, treat,
or prevent a disease), then the FDA considers it a drug subject to NDA requirements,
etc.

2.2 Dietary Supplements

A Dietary Supplements is defined as a product that is intended for ingestion; intended to supplement
the diet; and that contains any of the following:
• Vitamin
• Mineral
• Herb or other botanical
• Amino Acid
• Dietary Substance for use by man to supplement the diet by increasing the dietary intake
• Concentrate, Metabolite, Constituent, Extract or combination of the above

2.2.1 Dietary Supplement Health and Education Act

Mandates that the FDA regulate dietary supplements as a special type of food rather than a
drug. DSHEA allows manufacturers of dietary supplements to make claims that previously would
have triggered pre-market approval requirements, including safety and efficacy (i.e.,
NDA). However, DSHEA does not allow claims that dietary supplements diagnose, treat, cure, or
prevent disease. Basically DSHEA allows dietary supplement manufacturers to promote
substantiated structure/function claims which would normally classify the product as a drug. Recall
that in the previous section that one of the applicable definitions for a drug was "articles (other than
food) intended to affect the structure or any function of the body of man or other animals". DSHEA
 effectively carves out this definition of drug for dietary supplements and allows dietary supplements
to promote structure/function claims without being classified as a drug.
DSHEA allows 4 types of nutritional support statements:
▪ That the product will benefit a classical nutrient deficiency disease as long as it also discloses the
prevalence of the disease in the US
▪ Description of the role of the dietary supplement in affecting the structure or function of the body
▪ Characterization of the documented mechanism by which a nutrient or dietary supplement acts to
maintain structure or function
▪ Description of the general well-being from consumption of a nutrient or dietary supplement (e.g.,
energizer)

2.2.2 Dietary Supplement Statements

The seller must have substantiation that any nutritional support statements are truthful and not
misleading. The label on the dietary supplement must state:
• “This product has not been evaluated by the FDA”
• “This product is not intended to diagnose, treat, cure, or prevent, any disease”

2.2.3 Examples of Acceptable Structure/Function Claims

Examples of acceptable structure/function claims would be “helps improve your mood” but can’t say
“reduces depression”; “maintains a healthy circulatory system” but not “prevents cardiovascular
disease;” “maintains cholesterol in a healthy range” but not “lowers cholesterol;” “supports the
immune system” but not “helps prevent colds and flu.”

2.3 Beyond Use Dates

2.3.1 Unit-Dose Beyond Use Dates
The United States Pharmacopeia (USP) recently revised certain product dating standard guidelines
relevant to pharmacy practice. For non-sterile solid and liquid pharmaceutical products repackaged
into unit-dose or single-unit containers, pharmacists must affix a “beyond-use date” that is “one
year or less, unless stability data or the manufacturer’s labeling indicates otherwise.” However, this
guidance was premised on a mean temperature of 25 degrees and using a material other than PVC,
which is commonly used in unit-dose packaging. The FDA subsequently issued a policy guide to
reflect the USP stance, but it was never finalized. For now, then, the default is the FDA previous
rule:
• Expiration date not to exceed 6 months, and that the six-month period not exceed 25% of the
remaining time between the date of repackaging and the expiration date on the unopened original
manufacturer’s container
• Example: In order to repack on 1/1/16 with a 6-month expiration date, the manufacturer’s container
must have an expiration date of 1/1/18 or later

2.3.2 Prescription Vial Beyond Use Dates

The USP Guidelines for beyond-use dates for multiple-unit containers, such as a typical
prescription vial, remain “not later than
▪ The expiration date on the manufacturer’s container or
▪ One year from the date the drug is dispensed, whichever is earlier.”
 New Jersey complies with the recommended USP guidelines for beyond use dates
for multiple use containers.

2.4 Durham Humphrey Amendment

Created a statutory distinction between prescription and OTC drugs. Drugs that were safe only
under the direction of a physician now require a prescription. Previously, manufacturers largely
determined whether a drug was prescription or OTC. The Durham-Humphrey amendment also
authorized refills on prescriptions, as well as oral (telephoned) prescriptions. The Durham
Humphrey Amendment also deemed the prescription label as meeting the adequate directions for
use requirement.

2.5 Kefauver Harris Amendment

This 1962 amendment to the FD&C Act was triggered by the Thalidomide disaster, and not so
surprisingly, required more carefully controlled clinical studies. It also imposed the additional
requirement that drugs be effective in addition to the safety requirement imposed by the original
1938 FD&C Act. The amendment also established Good Manufacturing Practices (GMP’s) and
increased the inspection authority of the FDA.

2.6 Good Manufacturing Practices

Good Manufacturing Practices (GMPs) are a set of regulations that establish minimum requirements
for the methods, facilities or controls used in the manufacture, processing, packaging, or holding of a
drug product. GMPs apply to manufacturers, not pharmacies, unless the pharmacies engage in
activities that might be deemed to be manufacturing (e.g. large scale compounding, etc). The FDA
provides these additional examples that would require the pharmacy to comply with FDA
registration, inspections, and GMPs:
▪ If the pharmacy in hospital A repackages drug products for its own use as well as for that in hospitals
B and C
▪ If a pharmacy chain repackages and re-labels quantities of drug products from the manufacturer's
original commercial containers for shipment to the individual franchises of the chain
▪ If similar repackaging and re-labeling are conducted by individual pharmacies as members of an
informal buying group
2.7 Adulteration and Misbranding
These are the two major violations of the FD&C Act recognized by the FDA.

2.7.1 Adulteration
Adulteration is a relatively simple concept. The act prohibits the interstate commerce of drugs and
devices with impurities, poisons, and decomposed ingredients. The statute also recognizes that
while the drug itself may be pure, it still may be considered adulterated within the meaning of the
statute if:
• It is prepared, packed or held under unsanitary conditions where it may have been
contaminated with filth or rendered injurious to health
• It is manufactured in a way that does not conform to Good Manufacturing Practice standards
established by the FDA
• The container is composed of a poisonous or deleterious substance that may leech into the contents
• It contains or is an unsafe color additive
• If it purports to be, or is a drug that is recognized in an official compendium, and its strength quality
or purity varies from official compendial standards (unless its variations are plainly stated on the
label)
• If the drug is not listed in an official compendium, yet the strength, quality or purity differs from that
which it purports to possess
• If it is a drug and any substance has been added to it to reduce its quality or strength, or any
substance has been substituted in whole or part

2.7.2 Misbranding
A drug or device is misbranded if:
• Its label or labeling is false or misleading in any particular
• The drug is listed in official compendium unless labeled and packed according to compendial
standards
• The package or the drug is misleading in the way it is filled or formed or is imitative of another drug,
or offered for sale under the name of another drug
• The drug is subject to , unless the label bears appropriate precautionary statements
• The drug/device is health-endangering if used in the manner suggested by the labeling
• The drug is subject to the PPPA and is not packaged accordingly
• Drugs dispensed via prescription if at any time prior to dispensing the label of the drug failed to state
at a minimum, “Rx only,” or says Rx only and is not
• If a pharmacist sells a drug without a prescription or refills a prescription without authorization
Remember that situations where the strength, quality or purity of a drug is affected
may be considered adulteration AND misbranding.

2.8 Drug Labels and Labeling

The term “label” means a display of written, printed, or graphic matter upon the immediate
container of any article; the term “labeling” means all labels and other written, printed, or graphic
matter upon any article or any of its containers or wrappers, or accompanying such article (e.g.
package insert).

2.8.1 Bulk Prescription Container Labels Must Contain

• The name and address of the manufacturer, packer, or distributor
• The established name of the drug product
• Ingredient information, including the quantity and proportion of each active ingredient
• If for other than oral use, the names of all inactive ingredients
• The quantity in terms of weight or measure (e.g. 100 mg)
• The net quantity of the container (e.g. 1000 tablets)
• A statement of the recommended or usual dosage, or reference to the package insert
• The legend: “Caution, federal law prohibits dispensing without a prescription” or “Rx only”
• The route of administration if it is not oral
• An identifying lot or control number
• A statement directed to the pharmacist specifying the type of container to be used in dispensing the
drug (e.g., Dispense in tight, light-resistant container)
• The expiration date, unless exempted
• Labeling on or within the package must contain adequate information for use
Note the surprising fact that an NDC number is not required on the bulk prescription
container, although it is requested on all prescription an OTC drug labels and
labeling.

The presence of an NDC number does not indicate that a drug has received an NDA
approval--it is simply assigned by the FDA for convenience purposes

2.9 OTC Drug Labels

• Identity of the product (established name) & pharmacologic property
• The name and address of the manufacturer, packer, or distributor
• The net contents of the package
• Cautions or warnings needed to protect the consumer
• Adequate directions for use
• Drug facts panel (click the hyperlink to see a sample drug facts panel)

2.9.1 Content and Format of the Drug Facts Panel

• Active Ingredients (including dosage unit and qty per dosage unit)
• Purpose
• Use(s), Indications
• Warnings
o e.g, external, vaginal, or rectal use only
o do not use (contraindications)
o ask doc before using (list of applicable conditions)
o ask doc or pharmacist (applicable drug-drug, drug-food interactions)
o when using (side effects and what to avoid)
o stop using (signs of toxicity)
o if pregnant or breast feeding warning
o keep out of reach of children and accidental overdose warning
• Directions
• Other information (as required by the monograph, regulation or approved labeling
• Inactive Ingredients
• Questions? (Optional), followed by telephone number

2.9.2 Other Adequate Directions for Use Requirements

• Normal dose for each intended use and doses for individuals of different ages
• Frequency and duration of administration or application
• Administration or application in reference to meals, onset of symptoms, etc
• Route of method of administration or application
• Any required preparation for use

Adequate directions for use” means directions under which the layman can
use a drug safely and for the purposes for which it is intended.

2.10 Bar Coding Requirements

The bar code requirement applies to manufacturers, repackers, relabelers, and private label
distributors. The following drug products are subject to the bar code label requirements:
• Prescription drug products that are sold to or used in hospitals
• Biological products; and
• OTC drug products that are dispensed pursuant to an order and are packaged or labeled for hospital
use, or marketed, promoted, or sold to hospitals.
Each drug product for which the bar code requirement applies must have a bar code that contains,
at a minimum, the appropriate National Drug Code (NDC) number in a linear bar code which must
be included on the drug label.

2.11 Tamper Evident Packaging Act

Enacted in response to the contamination of Tylenol capsules with cyanide in 1982.

• Requires that all OTC human drug products and cosmetic liquid oral hygiene products, vaginal
products, and contact lens solutions and tablets be packaged in tamper-evident packaging
• Defined as having one or more indicators or barriers to entry, which, if breached or missing, can
reasonably be expected to provide visible evidence that tampering has occurred
• Labeling statement required to alert consumer to tamper-resistant feature(s) used. Statement
required to be placed so that it will be unaffected if a TRP feature is breached or missing
• Alternatively, the package can be “distinctive by design” (i.e., the packaging can not be duplicated
with commonly available materials or processes)
• In addition, two-piece hard gelatin capsules must be sealed using an acceptable tamper-evident
technology

Don’t confuse the Tamper Evident Packaging Act requirements with those of the
Poison Prevention Packaging Act. The PPPA requires child-resistant packaging for
certain drugs. Tamper evident packaging is not necessarily child-resistant.

Exceptions to the Tamper resistant packaging requirements include Dermatologicals;

Dentifrices; Insulin, and Lozenges.

2.12 Poison Prevention Packaging Act

The PPPA is enforced by the CPSC (Consumer Product Safety Commission) not the FDA.
• Requires CRC (child-resistant caps) i.e., 80% under 5 cannot open and 90% of adults can open
• Unit-dose test failure occurs if a child can access more than eight doses or a toxic amount,
whichever is less
• The physician or patient can request non-child resistant packaging
• The request can be oral or written, but only the patient can issue a request for a blanket waiver; the
physician cannot
• Blanket waiver requests can also be made on behalf of all the members of a family by the head of
household

2.12.1 Manufacturer Exemptions

A manufacturer that produces multiple package sizes of an OTC drug that requires child-resistant
packaging is allowed to produce one of the package sizes in a non-CRC packaging, provided the
statement “This package for households without young children” or “Package not child-resistant”
accompanies the package.

2.12.2 Re-Use of Vials and Bottles

As a general rule prescription bottles and vials cannot be reused. This prohibition is based on the
wear associated with a plastic vial, which could compromise the effectiveness specifications. Since
such wear or undetected damage with a glass container is negligible, the CPSC has indicated that it
would have no objection to the reuse of a glass container, provided a new child-resistant closure is
used. This same consideration would be given to any other package type that is not prone to wear.
2.12.3 Prescription Exceptions to the PPPA
In general, the PPPA requires that prescription medications be dispensed in child-resistant
containers. The table below lists the exceptions to that requirement and the applicable threshold
quantities. For updates to this list, you can check 16 CFR § 1700.14.

Drug Amount
Nitroglycerin
N/A
Sublingual dosage forms
Isosorbide Dinitrate
10 mg or less
Sublingual and chewable forms
NMT 110 mg of Sodium Fluoride per
Sodium Fluoride products package (equivalent of 50mg of elemental
fluoride per package)
Anhydrous Cholestyramine
N/A
Powder form
Methylprednisolone tablets NMT 84 mg of the drug per package
Mebendazole tablets NMT 600 mg of the drug per package
Betamethasone tablets NMT 12.6mg of the drug per package
Potassium supplements in unit-dose form,
including effervescent tablets, unit-dose vials
NMT 50 meq per unit dose
of liquid potassium, and powdered potassium
in unit-dose packets
Erythromycin ethyl succinate granules for NMT 8 gm. of the equivalent of
oral suspension and oral suspensions erythromycin per package
Colestipol
Up to 5 gm in a packet
Powder form
Erythromycin Ethyl Succinate tablets NMT16 gm of the drug per package
Preparations in aerosol containers intended
N/A
for inhalation therapy
Pancrelipase preparations N/A
Prednisone tablets NMT 105 mg per package
Oral Contraceptives
Cyclically Administered in manufacturer's N/A
memory-aid dispenser packages
 Drug Amount
Conjugated estrogen tablets when dispensed
NMT 32 mg of the drug
in mnemonic dispenser packages
Medroxyprogesterone Acetate tablets. N/A
Norethindrone Acetate tablets in mnemonic
NMT 50 mg of the drug
dispenser packages
Sacrosidase (sucrase) preparations in a
N/A
solution of glycerol and water.
Hormone Replacement Therapy products that
rely solely upon the activity of one or more N/A
progestogen or estrogen substances

Prescription Exceptions to the Poison Prevention Packaging Act

2.12.4 OTC Requiring Child Resistant Packaging

OTC Drugs Subject to the Requirements of the PPPA.
 Drug Amount
Aspirin
Any Amount
Any oral dosage form
Iron-containing drugs Elemental iron of 250mg. or more
Iron-containing dietary supplements Elemental iron of 250 mg/package

More than 1 gram in a single package

Acetaminophen
More than 66 mg of Diphenhydramine base
Diphenhydramine HCl
in a single package
Ibuprofen in oral dosage forms 1 gm. or more in a single package
Greater than 0.045 mg/ single package of
Loperamide
an oral dosage form
Lidocaine More than 5.0 mg in a single package
Dibucaine More than 0.5 mg in a single package
Mouthwashes 3 g or more of ethanol in a single package
Containing the equivalent of 250mg in a
Naproxen preparations
retail package
Containing more than 50mg in a single
Ketoprofen preparations
package
Containing more than 14 mg in a single
Minoxidil preparations
retail package
Containing more than 50 mg. of elemental
Fluoride
fluoride per package
Over the counter drug products that was
previously available by prescription

OTC Drugs Subject to the Requirements of the PPPA.

Requests for e-z open containers are not required to be in writing, but this is strongly
encouraged by the CPSC
A blanket waiver would be a single request that all subsequent prescriptions be
packaged in non child resistant packaging.
 Certain effervescent powders containing acetaminophen or aspirin are exempt from
CRC requirements as well as certain unflavored acetaminophen or aspirin powders

2.13 Prescription Drug Marketing Act

The Prescription Drug Marketing Act was enacted to regulate the handling of prescription drug
samples as well as the purchases and re-sales of drugs by hospitals, health care entities, and
charitable institutions. The PDMA additionally requires the licensing of all drug wholesalers.

2.13.1 Drug Samples

The PDMA bans the trade, sale, or purchase of drug samples. Formerly, prescription samples were
unregulated and often illegally resold. The drugs were often adulterated and misbranded since they
were stored under improper conditions and were improperly labeled (e.g., mixing lot numbers in the
same bottle, etc.) The PDMA now requires that requests for samples must be initiated by the
physician and can be requested by a physician for storage in a hospital pharmacy but not a retail
pharmacy. The request must be in writing and a receipt must be issued.

2.13.2 Resale of Drugs Purchased by Hospitals, Health

Care Entities and Charitable Institutions
Drug diversion also affected the purchases originally made by hospitals and other health care
entities that are able to purchase drugs at a substantially lower rate than their retail pharmacy
counterparts. Frequently, the drugs were being resold at a higher markup and much of the same
adulteration and misbranding problems were occurring. The PDMA prohibits the sale, purchase, or
trade (or even to make the offer to sell purchase or trade) of prescription drugs that have been
purchased by a hospital, health care entity, or charitable organization. Exceptions to the law would
include:
• Sales to non-profit affiliates, sales to/from other member hospitals of a group buying organization
• Emergency sales or transfers to a community pharmacy experiencing a temporary shortage of a
prescription drug
• Sales pursuant to an outpatient prescription in the hospital

2.13.3 Pedigree Requirement

A pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug,
including dates of transactions, and names and addresses of all parties to them. Originally, the
PDMA allowed the FDA to require a pedigree if the entity was not the manufacturer or an authorized
distributor of record (i.e., major wholesaler). A court invalidated this provision because it unfair
economic impact on secondary wholesalers.
Title II of Drug Quality and Security Act of 2013 now applies to all manufacturers, wholesalers,
repackagers, and dispensers. It sets a timeline for implementation of a “track and trace” pedigree
program.
Beginning 1/1/2015 mfgrs must pass transaction data to subsequent purchasers. Wholesalers and
repackagers must also pass the transaction data along. For now, any method is acceptable (e.g.
paper, electronic)
• By January 1, 2015 all partners were required to have systems in place to quarantine, investigate,
and notify FDA of any suspect drug product
• Within 10 years,all partners need a fully electronic, interoperable track and trace program
• By 11/2023, all partners required to electronically track and trace all products using standardized
numerical identification (SNI) NDC + 20 digit serial number

2.14 Drug Recalls

Drug recalls are divided into three classes:
• Class I recall is issued when there is a possib ility that the product will cause serious
adverse health effects or death
• Class II recalls are issued when the product may cause temporary or medically reversible adverse
health effects, but that the probability of serious health effects is remote
• Class III recalls are issued when the product is not likely to cause adverse health effects
Pharmacists should be aware that if they dispense any drug that has been recalled, they can be
charged with a violation of the Food Drug and Cosmetic Act
The FDA does not have the statutory authority to order a drug recall but will either
ask a company to initiate one in lieu of injunctive relief or a seizure, which the FDA can
undertake if a company does not respond to their request.

2.15 Patient Package Inserts

Patient package inserts are required to accompany the following drugs:
• Oral contraceptives
• Estrogens (e.g., PREMARIN)

2.15.1 Institutional Distribution of Package Inserts

Institutions are also required to adhere to this requirement in modified form.
• Patients can be given the insert with each prescription, or
• Patients can be given the insert with the first dose and then again every thirty days
Generally, the patient package insert must contain the name of the drug; summary of
effectiveness, contraindications, risks, and benefits; etc. If no insert is provided, it is
considered misbranding.
As a practical matter, it appears that the FDA has adopted the Medication Guide as a
preferred method of communicating information about a drug to a patient instead of
a patient package insert.

2.16 Medication Guides

2.16.1 Circumstances where a medication guide is required
FDA is authorized to require a Medication Guide if it determines one or more of the following
circumstances exist:
• The drug product is one for which patient labeling could help prevent serious adverse effects
• The drug product is one that has serious risk(s) (relative to benefits) of which patients should be
made aware because information concerning the risks could affect patients’ decision to use, or
continue to use, the product
• The drug product is important to health and patient adherence to directions for use is crucial to the
drug’s effectiveness

2.16.2 Manufacturer and Pharmacy Responsibilities

Manufacturers of drug products for which a Medication Guide is required must:
• Obtain FDA approval of the Medication Guide before the Medication Guide is distributed, and
• Ensure that Medication Guides are provided in sufficient numbers, or provide the means to produce
Medication Guides in sufficient numbers, to distributors, packers, and authorized dispensers to
permit the authorized dispenser to provide a Medication Guide to each patient receiving a
prescription for the drug product.
Each authorized dispenser of a prescription drug product for which a Medication Guide is required
must provide the Medication Guide directly to each patient or each patient’s agent when the product
is dispensed, unless an exemption applies. Currently, medication guides are required for over 300
products. For a complete listing of drugs requiring a Medication Guide, click here.
Medication Guides are applicable to both new and refill prescriptions.

2.17 Risk Evaluation and Mitigation Strategies

(REMS)
The FDA Amendments Act (FDAAA) signed into law in 2007 granted the FDA broad new authorities
related to the safety of new and already approved drugs, which included the power to require use
of Risk Evaluation and Mitigation Strategies (REMS) for new and already-marketed drugs to
ensure the benefits of certain drugs outweigh their risks. A complete listing of approved REMS
is available at http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm
REMS may include one or more of the following components: medication guides communication
plans, and/or elements to assure safe use (ETASU).
Medication guides are handouts used to inform patients about the safe and effective use of a drug
in order to help them avoid serious adverse events. Communication plans utilize various methods
of dissemination (e.g., direct mailings, communications via professional societies, etc.) to
communicate risk and REMS-related information to health care providers. Elements to Assure Safe
Use are reserved for drugs associated with a serious risk of adverse drug experiences that would
otherwise be denied approval or withdrawn.
ETASU may include one or more of the following:
• Special Training and/or certification requirements for prescribers or dispensers of the drug
• Restricting distribution of the drug to particular care settings
• Dispensing a drug based on evidence or documentation of safe use conditions (e.g., patient
counseling and acknowledgement of risks and benefits, signing informed consent form)
• Patient monitoring and follow-up (e.g., periodic lab testing)
• Patient Registries
 2.18 REMS for ER/LA Opioid Analgesics
This is an example of a very simple REMS. The central component of the ER/LA opioid analgesics
REMS is an education program for prescribers (e.g., physicians, nurse practitioners, physician
assistants). Under the REMS, sponsors of ER/LA opioid analgesics will make available education
programs to all DEA registered prescribers. FDA expects that sponsors will meet this obligation by
providing educational grants to accredited CE providers to offer training to prescribers at no or
nominal cost.
Prescriber education will include drug information on ER/LA opioid analgesics; information on
assessing patients for treatment with these drugs; initiating therapy, modifying dosing, and
discontinuing use of ER/LA opioid analgesics; managing therapy and monitoring patients; and
counseling patients and caregivers about the safe use of these drugs. Additionally, prescribers will
learn how to recognize evidence of and potential for opioid misuse, abuse, and addiction.
The ER/LA opioid analgesics REMS will also include a patient counseling document for prescribers
to give to patients, helping prescribers to properly counsel patients on their responsibilities for using
these medicines safely. Patients will receive from their pharmacist an updated one-page
Medication Guide along with their prescription that contains consumer-friendly information on the
safe use and disposal of ER/LA opioid analgesics. Included in the guide are instructions for patients
to consult their health care professional before changing doses, signs of potential overdose and
emergency contact instructions, and advice on safe storage to prevent accidental exposure to family
members.

2.19 Restricted Distribution Systems

Listed below are some of the more popular REMS examples that employ ETASU’s that effectively
result in restricted distribution systems. The ETASU components of the applicable REMS are
available at http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm
It is advisable to review the individual REMS of the drugs listed below for completeness, since the
complete information is too voluminous to list here.

2.19.1 Isotretinoin I Pledge Program

The iPLEDGE program is a computer-based risk management program designed to eliminate fetal
exposure to isotretinoin through a special restricted distribution program approved by the FDA. The
program strives to ensure that:
• No female patient starts isotretinoin therapy if pregnant
• No female patient on isotretinoin therapy becomes pregnant
This enhanced program is a SINGLE pregnancy risk management program for prescribing and
dispensing all isotretinoin products. The iPLEDGE program requires registration of all wholesalers
distributing isotretinoin, all healthcare professionals prescribing isotretinoin, all pharmacies
dispensing isotretinoin, and all male and female patients prescribed isotretinoin. This program is
designed to create a verifiable link between the negative pregnancy test and the dispensing of the
isotretinoin prescription to the female patient of childbearing potential.
As part of the ongoing risk management of isotretinoin products, it is crucial that a female of
childbearing potential selects and commits to use two forms of effective contraception
simultaneously for one month before, during, and for one month after isotretinoin therapy. She must
have 2 negative urine or blood (serum) pregnancy tests before receiving the initial isotretinoin
prescription. The first pregnancy test is a screening test and can be conducted in the prescriber’s
office. The second pregnancy test must be done in a CLIA-certified laboratory according to the
package insert. Each month of therapy, the patient must have a negative result from a urine or blood
(serum) pregnancy test conducted by a CLIA-certified laboratory prior to receiving each prescription.
Each month, the prescriber must enter the female patient’s pregnancy results and the 2 forms of
contraception she has been using in the iPLEDGE system. The iPLEDGE system verifies that all
criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy
authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the
iPLEDGE system via the program web site or phone system prior to dispensing each isotretinoin
prescription for both male and female patients.

2.19.2 Thalidomide (Thalomid)

1998, FDA approved the marketing of thalidomide (Thalomid, Celgene). Because of the drug's
known teratogenic effects, FDA tightly controls the distribution of thalidomide in the United States.
To comply with FDA requirements, Celgene developed the S.T.E.P.S. oversight program, which
includes registration of thalidomide prescribers and pharmacies that dispense thalidomide, extensive
patient education about the risks associated with thalidomide, and a registry of all patients receiving
thalidomide.
The S.T.E.P.S. program uses a three-pronged approach: (1) controlling access to the drug; (2)
educating prescribers, pharmacists, and patients; and (3) monitoring compliance. Clinicians who
wish to prescribe thalidomide must be registered in the S.T.E.P.S. Prescriber Registry and agree to
prescribe the drug in accordance with S.T.E.P.S. patient eligibility criteria and monitoring
procedures. Pharmacies must also register and agree to comply with patient identification and
monitoring criteria. Finally, patients receive visual aids, including a videotape, written material, and
verbal counseling about the benefits and risks of thalidomide therapy, the importance of not
becoming pregnant during therapy, and the types of contraception required (including emergency
contraception) and their availability. Women of childbearing potential must agree to undergo
pregnancy testing before starting therapy and on a regular schedule during therapy. All patients
must agree to complete a confidential survey about their compliance with contraception, testing, and
drug therapy.

2.19.3 Clozaril (Clozapine)

Clozapine is a potent atypical antipsychotic with efficacy in the treatment of refractory schizophrenia.
Clozapine poses a high risk of agranulocytosis. In 1990 a “no blood, no drug” program was initiated,
which allowed registered physicians caring for patients to prescribe clozapine provided that weekly
complete blood cell counts (CBCs) were obtained prior to drug dispensing. The Clozaril® “no blood,
no drug” program—which also mandated physician, pharmacist, and patient registration; a patient
database; and ongoing compliance monitoring and feedback—is regarded as successful. The
program has been modified over the years based upon patient experience and data to permit longer
intervals between laboratory tests and drug dispensing.
A pharmacist that wishes to dispense Clozaril must have his/her facility/store registered with the
Clozaril National Registry, in order to purchase Clozaril from the wholesaler. When a patient
presents a prescription for Clozaril, and the patient is new to the pharmacy, the pharmacist must
verify that the patient is eligible and registered with the CNR, before dispensing Clozaril. For both
new and existing patients, the prescriber must also supply the pharmacist with a current blood work
result (drawn within 7 days irrespective of monitoring frequency and including a CBC and ANC-
absolute neutrophil count) prior to dispensing. There are several manufacturers of Clozapine but
they all have similar registry programs.
 2.19.4 Tracleer (T.A.P.)
This program limits the availability of Tracleer (bosentan) to specialty distributor pharmacies
participating in the Tracleer Access Program (T.A.P.) It also requires the certification of prescribers
and dispensers and enrollment of patients. Educational requirements apply to prescribers,
dispensers, and patients as well.

2.19.5 Lotronex (Alosetron)

Healthcare providers who prescribe LOTRONEX will be specially certified in the Prescribing
Program for Lotronex (PPL). Each patient prescribed LOTRONEX must have signed a Patient
Acknowledgement Form for documentation of safe-use conditions. Pharmacists will only dispense
LOTRONEX to patients with documentation of safe-use conditions.
The pharmacists will only dispense a prescription for LOTRONEX in the presence of a PPL
sticker.
• The PPL sticker provides verification to the pharmacist that the prescription is written by a certified
prescriber enrolled in the PPL.
• Pharmacists will not accept telephone, facsimile, or computerized prescriptions for LOTRONEX.

2.19.6 TRANSMUCOSAL IMMEDIATE RELEASE

FENTANYL (TIRF)
• Abstral (fentanyl) Sublingual Tablets
• Actiq (fentanyl citrate) Oral Transmucosal Lozenge and the generic equivalents
• Fentora (fentanyl citrate) Buccal Tablets
• Lazanda (fentanyl) Nasal Spray
• Onsolis (fentanyl) Buccal Soluble Film
• Subsys (fentanyl) Sublingual Spray
Healthcare providers who prescribe TIRF medicines for outpatient use are required to be specially
certified. In addition, TIRF medicines will only be dispensed by pharmacies that are specially
certified. TIRF medicines will only be dispensed for outpatient use with evidence or other
documentation of safe-use conditions. Patients are also required to sign a Patient-Prescriber
Agreement Form.

2.19.7 Erythropoiesis-Stimulating Agents (ESAs) (e.g.,

Procrit, Epogen, and Aranesp
Elements to ensure safe use are incorporated into the ESA APPRISE Oncology Program: (1) health
care provider training and certification, (2) hospital certification, and (3) dispensing following the
documentation of safe-use conditions. All prescribers who plan to order ESAs for cancer patients
must receive training and must enroll in ESA APPRISE. The manufacturer maintains an on-line list
of enrolled prescribers through an independent third party. Prescribers must counsel patients on the
risks and benefits of ESA's, and patients must sign an acknowledgement form that they are
consenting to the use of the product (i.e., documentation of safe-use conditions). When used in a
hospital setting, the hospital must appoint a designee to receive training and enroll in APPRISE on
behalf of the institution. That person is responsible for implementing the policies and procedures at
the hospitals as well as instituting the protocols for complying with all of the REMS requirements,
 including verifying that before any ESA is administered in the hospital, ensuring that the prescriber is
certified and has obtained a copy of the acknowledgement form from the patient.

2.20 Plan B
In August 2006, the Food and Drug Administration approved over-the-counter (OTC) sales of the
emergency contraceptive drug Plan B (two 0.75 mg levonorgestrel pills) for women age 18 years
and older. A subsequent district court decision required the FDA to reconsider the age
requirement. The required age then became 17 to purchase Plan B without a
prescription. Individuals under age 17 at that time still required a doctor's prescription to obtain Plan
B.
A more recent update has occurred whereby a Federal Judge stated that there should be no age
restriction at all, but that would not become official until it was determined whether the court decision
would be appealed. In the meantime in a totally separate action, the FDA reduced the age to 15 and
over.
A final update has occurred whereby an original appeal of the court's decision has been
dropped. Upon receiving a supplemental application from Teva, the manufacturer of Plan B One-
Step, the FDA granted exclusive rights to sell this drug over-the-counter to all ages. This marketing
exclusivity extended until April 2016. The generic one-tablet versions of Plan B One Step are now
also available over-the-counter for women 17 and older (i.e. in the regular store aisle), while women
16 and younger will need a prescription. However, this is somewhat of a moot point since
pharmacies are not routinely checking the ages of those purchasing the generic one-tablet versions
from the regular store aisle.
Generic two-tablet versions are only available at the pharmacy counter for those 17 and older, while
women 16 and younger need a prescription.

It is interesting to note that the age requirement for purchasing Plan B otc applies to
males as well.

2.21 IND/NDA Approval Process

2.21.1 IND Application
An Investigational New Drug (IND) approval is subject to the FDA receiving:
• Information on the name of the drug, its composition, methods of manufacturing, quality control,
information from pre-clinical (animal) testing, pharmacological, pharmacokinetic, and toxicology
studies
• An outline of the proposed clinical studies as well as the experience of the clinical investigators
If the FDA doesn't reject the IND application within 30 days of submission, clinical testing on humans
may begin.
 2.21.2 Phases of Clinical Testing in Humans
• PHASE I studies are performed on a small number of healthy persons (20-80), and is used to
determine the pharmacology of the drug and its toxicology, not efficacy
• PHASE II studies are performed on a limited number of people (100-300) who actually have the
disease to determine efficacy
• PHASE III studies are performed on a larger scale of affected individuals (1,000-3,000). If the
results of the clinical trials are favorable, then the company will submit an NDA to the FDA for
consideration
• PHASE IV studies are performed after a drug has been granted FDA approval and would primarily
occur in 2 contexts. The first would be if the FDA had performed an expedited approval of a drug
and wanted the manufacturer to complete more clinical studies. The second would be if the
manufacturer wanted the FDA to approve an additional indication for a drug, and was performing
clinical studies to support that request.

2.21.3 Investigational Drugs for use in the General Population

Investigational drugs can be approved for patients in the general population provided that:
• It is pursuant to a treatment protocol that has been submitted to the FDA
• The drug is used to treat a serious or immediately life-threatening disease
• There is no comparable or satisfactory alternative drug or other therapy available
• The drug is an approved investigational new drug being used in a controlled clinical trial, or all
clinical trials have been completed, and the sponsor of the clinical trial is actively pursuing market
approval

2.21.4 Process for a Physician to obtain Investigational Drugs for

individual patient not involved in the clinical study
The physician should first ensure that the manufacturer of the unapproved drug is willing to provide
the drug. If the manufacturer agrees to provide the drug, the physician should submit an IND to the
FDA. An IND for individual patient use of an investigational drug must normally be received by the
FDA before shipment of and treatment with the drug may begin. A number will be assigned to the
application. The treating physician should provide this IND number to the drug supplier, so the
supplier may ship the drug to the treating physician. The FDA will either allow the treatment use to
proceed or not allow it to proceed (put the application on clinical hold). Treatment with the drug may
proceed 30 days after FDA receives the IND submission and has not otherwise put the application
on hold, or upon earlier notification of the physician by FDA.

2.21.5 Required Content of the IND for individual patient use:

• Statement that this is a request for an individual patient IND for treatment use
• Brief Clinical History of the patient
• Proposed Treatment Plan
• Chemistry, Manufacturing, and Controls Information and Pharmacology and Toxicology Information,
which can usually be obtained by getting a Letter of Authorization from the manufacturer based on
what has been previously submitted to FDA (e.g., an existing IND or NDA)
• Informed Consent Statement that states that informed consent and approval of the use by an
appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment.
• Investigator Qualification Statement that specifies the training, experience, and licensure of the
treating physician. (e.g., Curriculum Vitae)
• FDA Form 1571 completed with the treating physician listed as the sponsor
• Contact telephone number and facsimile number

2.21.6 Expedited Approval of Drugs by the FDA

Expedited approval process also exists for drugs that treat serious life-threatening illnesses and that
also provide a meaningful therapeutic advantage over existing treatments (e.g., AIDS drugs). The
approval is conditioned upon on completing Phase IV post-marketing studies.

A sponsor may not normally charge a patient for a drug used in an investigational
study without special approval from the FDA; informed consent must also be

2.22 OTC Drug Approval Process

OTC products can be marketed under a New Drug Application (NDA), Abbreviated New Drug
Application (ANDA), or under an OTC monograph. Under the OTC Drug Monograph Process, the
FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, (e.g.,
anti-diarrheals, analgesics, antacids), instead of individual drug products. For each category, an
OTC drug monograph is developed and published in the Federal Register. OTC drug monographs
can be likened to recipe, whereby the manufacturer adheres to the acceptable ingredients, doses,
formulations, and labeling in the OTC monograph. The monographs define the safety, effectiveness,
and labeling of all marketing OTC active ingredients. Interestingly, pre-approval by FDA for drugs
marketed under a drug monograph is not required (i.e., you simply follow the “recipe”). On the other
hand, if a drug cannot comply with the drug monograph, an Investigational New Drug Application
and approved NDA is necessary before the drug product may be marketed.
It would be advisable to check out an actual monograph to get a better appreciation of how they
work. For example, see 21 CFR Part 331 for a discussion of the OTC monograph for antacids by
clicking here. Then see how the monograph translates to an actual antacid drug facts panel label by
clicking here.

2.23 Switch of Prescription Drugs to Over the Counter

Drugs
May occur in one of 3 ways:
• The mfgr. can request the switch by submitting a Supplemental application to its original NDA
• The mfgr. may petition the FDA
• The FDA may add or amend an existing OTC monograph
 2.23.1 Prescription or OTC?
Another important consideration in determining otc vs. prescription status relates to the adequate
directions for use requirement that applies to otc products. When Meclizine is sold and labeled
for motion sickness, it is considered an otc product. However, when it is sold for the treatment of
vertigo, it is considered a prescription item because the adequate directions for use requirement
cannot be met on the otc label.
Similarly, Ibuprofen, when used for mild to moderate pain, is considered otc, but when used for the
treatment of rheumatoid or osteoarthritis, it is considered a prescription drug.

2.24 New Drugs

A drug becomes a “new” drug subject to the NDA approval process from the FDA:
• When the drug contains a new substance (e.g., active ingredient, carrier, excipient, or coating, etc.)
• When there is a new combination of approved drugs
• When the proportion of ingredients in combination is changed
• When the dosage, method, duration of administration, or application is changed
• When a new use for a drug is claimed, even though the drug is not “new,”(e.g., manufacturer
claiming that a drugs is useful in the treatment of another disease not on the original list of approved
indications.)

2.24.1 Unlabeled Uses

Correspondingly, even though a drug may be legally marketed only for those indications on the NDA
application, a practitioner may sometimes write a prescription for an unlabeled use for a given
drug. The pharmacist can legally fill these prescriptions, but is expected to use professional
judgment when doing so. The manufacturer may also distribute peer-reviewed literature that
describes an off-label use.

2.25 Waxman Hatch Amendment

This amendment to the FD&C Act, which is also known as the Drug Price Competition and Patent
Term Restoration Act of 1984, made it easier for generic drugs to get FDA approval. The generic
manufacturer is not required to prove the safety and efficacy of the drug through clinical studies but
rather only has to show that the drug is bioavailable and bioequivalent to the innovator drug. As a
compromise, the amendment also extended the patent life for the time of the FDA approval
process. It also grants exclusivity rights in certain cases for brand-name manufacturers. For
example, a 3-year marketing exclusivity is granted for any new uses developed by the pioneer
manufacturer for an existing drug whose patent is expiring.

2.26 Drug Advertising

The FTC regulates the advertising of OTC drugs.
The FDA regulates the advertising of Rx drugs
 2.27 Medical Device Amendments of 1976
Provided for the classification of devices and required various controls on devices based on an
evaluation of their function. Pre-marketing approval is required to determine the safety and efficacy
of life-sustaining and life-supporting devices. Manufacturers have to report deaths and serious
injuries caused by a medical device to the FDA. Devices are classified as follows:
• Class I devices are those that require the least regulation; general controls are adequate to insure
safety and effectiveness. These devices include needles, scissors, stethoscopes, and toothbrushes,
etc.
• Class II devices are those for which general controls are insufficient to ensure safety and
effectiveness. These products must meet specific performance standards established by the
FDA. Such products are insulin syringes, thermometers, diagnostic reagents, soft or hard contact
lenses for daily use, and electric heating pads. The imposition of performance standards for Class
II devices makes sense when you realize that all devices in this classification require some sort of
measurement that need to be tested. (e.g., are the lines on the insulin syringe calibrated correctly?)
• Class III devices must have pre-market approval because they are life supporting or life sustaining,
or they present a potential unreasonable risk of illness or injury. They include pacemakers, soft or
hard contact lenses for extended use, replacement heart valves.

2.28 Safe Medical Device Act of 1990

Manufacturers historically have been required under the Medical Device Amendments Act to report
deaths and serious injuries. This Act requires that:
• Device user facilities of medical devices (hospitals, etc.) report serious injuries or illness caused
by a device within 10 working days to the manufacturer or the FDA, if the manufacturer is not
known
• Device user facilities of medical devices (hospitals, etc.) report a device causing a death to the FDA
and manufacturer w/in 10 working days

2.28.1 Additional Requirements

For permanently implantable or life-sustaining devices:
• Requires a manufacturer to adopt a method of device tracking to ensure that patients can be
notified if necessary. Similar restrictions have since been placed on distributors
• Requires a manufacturer to conduct post marketing surveillance
The FDA is authorized to require a manufacturer to recall the device in
question. Recall that the FDA cannot order drug recalls.

2.29 Expiration Dating

• OTC drugs are exempt from expiration dating if they are stable for at least 3 years and their labeling
does not bear dosage limitations.
• Expiration dating of Dec 2016 would imply Dec 31, 2016
 2.30 FDA Inspections
The FDA inspection must be conducted at a reasonable time in a reasonable manner and
be reasonably limited. Basically this means is that the inspection will occur during normal business
hours with minimal interruption, which is not the case with a search warrant, which can be served
any time of day or night.
The FDA inspector only needs to present credentials and a Notice of Inspection. Unlike the CSA
Notice of Inspection, however, the pharmacy owner cannot refuse the inspector access to the
pharmacy.

2.31 Uses of Tax Free Alcohol

Tax-free alcohol may be used for scientific, medicinal and mechanical purposes, and in the
treatment of patients. Some typical uses include its use in a hospital:
• In sterilizing solutions
• As an antiseptic
• As a vehicle in compounding prescriptions, and
• In the preparation of specimens
Tax-free alcohol itself may not be sold to a patient, but a separate charge can be made for
medicines compounded on the premises and dispensed to patients for use on the premises. For
example, if a hospital pharmacy is compounding an elixir for an inpatient, any amount of tax free
alcohol they use in that preparation can't be charged to the patient. However, it does allow the
hospital pharmacy to charge the individual in-patient for the any other medication that is included in
that compounded elixir.
There are some other restrictions on tax free alcohol. It can’t be given to patients as a beverage or
used as food, even though sometimes a physician will order alcohol for a patient in a hospital. For
example, a doctor might order an alcoholic drink for a patient at bedtime. When this occurs, the
hospital will not be using tax free alcohol, but rather alcohol that has been brought in by the family or
some other form of traditional alcohol that is purchased at a liquor store. So make sure you make
the distinction between tax free alcohol and alcohol that is not tax free. The latter can be consumed
as a beverage in a hospital setting while the tax free alcohol cannot.
There is an additional restriction from using tax free alcohol at all in the preparation of any
compounds that are sold to outpatients or patients of a retail pharmacy. Therefore, the only time you
can use tax free alcohol in a compound is when you are compounding a preparation for an
inpatient.

2.32 FDA Classification of Drugs Taken During Pregnancy

On December 3, 2014 the U.S. Food and Drug Administration (FDA) issued a final rule which
enacted major revisions to prescription drug labeling to provide more complete information about the
effects of medicines used during pregnancy and breast-feeding. The rule effectively eliminated the
current pregnancy categories A, B, C, D, and X.
Both the pregnancy and lactation subsections now have three principal components: a risk
summary, clinical considerations, and a data section.
Risk summary- begins with a one sentence statement that summarizes the potential of the
medication to increase the risk of the following: structural abnormalities, fetal and infant mortality,
impaired physiologic function, and alterations to growth. This summary states if animal or human
data was used. If human data was used, the summary goes into greater detail. In the event animal
data was presented, only a risk conclusion statement is provided.
 Clinical Considerations- addresses situations in which a woman was inadvertently exposed to the
drug, any effects the medication will have in labor and delivery, and decisions that clinicians may
have to make while prescribing these medications to pregnant women including:
• Dosing adjustments during pregnancy
• Adverse reactions unique to pregnancy
• Interventions that may be required while receiving the medication
Data- this section includes all available data for the medication and its use in pregnant women.
Human data takes precedence over animal data. It describes the types of studies completed, which
animals were used, dosage, the type of adverse events (if any) observed, and, if applicable, the
relationship between drug exposure in animals and humans.
Click here for a copy of the Final FDA Rule implementing this regulation for a more complete
discussion.

2.33 Prescription Compounding

Compounding provisions were included in the Food & Drug Administration Modernization Act
(FDAMA) that took effect in November 1998. Prior to that, there was no comprehensive federal law
that addressed compounding, and there was always confusion over the authority that the FDA had
over compounding. At any rate, FDAMA addressed some very important issues in clarifying that
traditional compounding pharmacies did not need to comply with Good Manufacturing Practices;
they did not have to seek FDA approval of the products that they compounded; and they only had to
put the physician specified directions on the label to comply with the adequate directions for use
requirement. This of course, was premised on abiding by the compounding provisions of FDAMA
which are summarized below.

2.33.1 Compounding Provisions FDAMA

The compounded drug must be:
• For an individual patient based on a valid prescription
• For a limited quantity if prepared in anticipation of a prescription (must be legitimately based on past
compounding history)
• Not essentially a copy of a commercially available product
• Compounded in compliance with USP chapters on compounding, using bulk substances that comply
with monograph standards (if they exist). If not, then the drug must be a component of an FDA
approved human drug product. Otherwise, then it must be on a list of approved bulk substances
developed by the FDA
• Compounded with bulk drugs manufactured by an entity registered with the FDA
• Compounded with ingredients (other than bulk substances) that comply with USP standards
• Not compounded from a list of drugs that they FDA has withdrawn from the market for safety or
efficacy reasons
• The compounder does not distribute more than 5% of the total prescriptions dispensed or distributed
by the pharmacy absent a memorandum of understanding between the pharmacy's state and the
FDA.
However, also included in the compounding provisions of the Modernization Act were advertising
restrictions on compounding, that a district court found were unconstitutional restrictions on free
speech. Unfortunately, the district court also stated that the entire compounding section was invalid
because all of the compounding provisions were closely intertwined . Ultimately, the case went to
 the Supreme Court, which concurred with the District Court on the free speech restrictions, but did
not say anything about tossing out the entire compounding provisions. With the status of the law
unclear at that point, the FDA issued a compounding policy guide that essentially was based on the
content of the FDA on compounding, minus the unconstitutional provisions. The next law related to
compounding did not occur until a compounding disaster associated with the North East
Compounding Center (NECC), which prompted the passage of the Drug Quality and Security Act

2.33.2 NECC Compounding Disaster

In 2012 a Massachusetts pharmacy, North East Compounding Center (NECC), compounded and
shipped large batches of contaminated sterile injectables to hospital pharmacies, doctors' offices,
and other entities. The products killed 64 individuals and injured more than 700 others. In an effort
to better regulate compounding facilities, especially sterile compounded products, Congress passed
the Drug Quality and Security Act, a summary of which is provided below.

2.33.3 Drug Quality and Security Act

On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA),
legislation that contains important provisions relating to the oversight of compounding of human
drugs. Title I of the law, the Compounding Quality Act, essentially reinstated the compounding
provisions included in FDAMA, while removing the unconstitutional provisions related to
advertising. Section 503A deals with traditional compounding and describes the conditions under
which certain compounded human drug products are entitled to exemptions from three sections of
the FDCA requiring:
• Compliance with current good manufacturing practices (CGMP) (section 501(a)(2)(B));
• Labeling with adequate directions for use (section 502(f)(1)); and
• FDA approval prior to marketing (section 505).
By removing the unconstitutional provisions, the new law removes uncertainty regarding the validity
of section 503A, which is applicable to compounders nationwide.
In addition, the new law creates a new section 503B in the FDCA. Under section 503B, a
compounder who compounds sterile products can become an “outsourcing facility.” An
outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and
the requirement to label products with adequate directions for use, but not the exemption from
CGMP requirements. Outsourcing facilities:
• Must comply with CGMP requirements,
• Will be inspected by FDA according to a risk-based schedule, and
• Must meet certain other conditions, such as reporting adverse events and providing FDA with certain
information about the products they compound.
If compounders register with the FDA as outsourcing facilities, hospitals and other health
care providers can provide their patients with drugs that were compounded in outsourcing
facilities that are subject to CGMP requirements and federal oversight.
FDA anticipates that state boards of pharmacy will continue their oversight and regulation of the
practice of pharmacy, including traditional pharmacy compounding. The Agency also intends to
continue to cooperate with State authorities to address pharmacy compounding activities that may
be violative of the FDCA.
 2.33.4 Summary
The Drug Quality and Security Act provides assurances that traditional compounding pharmacies
(i.e., those that compound based on individual prescriptions for individual patients) do not need to
comply with Good Manufacturing Practices; they do not have to seek FDA approval of the products
that they compound; and they only have to put the physician specified directions on the label to
comply with the adequate directions for use requirement. On the other hand, large batch sterile
compounders are provided a vehicle under the Act, namely to become outsourcing facilities.
Outsourcing facilities are under much more FDA scrutiny, but this provides greater assurance that
disasters such as that occurred with NECC do not happen again. It also allows hospital pharmacies
and doctors' offices to legally buy sterile compounded products from outsourcing facilities.

2.34 Ipecac to Prevent Poisonings

The Commissioner of the FDA has determined that it is in the interest of the public health for ipecac
syrup to be available for sale without prescription, provided that it is packaged in a quantity of 1 fluid
ounce (30 milliliters), and its label bears, in addition to other required label information, 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 kerosene, 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.
2.35 Insulins and the Requirement for Prescription
Analog Insulins require a prescription. Rapid-Acting Analog Insulins include Humalog (Lispro),
Novolog (Aspart); and Apidra (glulisine). Long-Acting Analog Insulins include Lantus (Glargine);
Tresiba (Degludec); Ryzodeg (Degludec/Aspart); and Levemir (Detemir).
Humulin and Novolin do not require a prescription.

2.36 Orange Book

Also called “Approved Drug Products with Therapeutic Equivalence Evaluations.
Involves a 2-letter coding system for the therapeutic equivalence evaluations of multi-source drug
products.
First letter is A or B, with A representing therapeutic equivalence (bioequivalence) to a reference
drug product and B representing either a documented bioequivalence problem or potential for a
problem.
The second letter of the code describes the dosage form or nature of the product
 2.36.1 Allowable Substitutions in General
In general, substitution is allowed only if drugs are therapeutically equivalent; i.e., A rated drugs can
be substituted for each other, (unless state law dictates otherwise).
B rated drugs cannot be substituted, either with an A rated drug or even another B rated drug.

It is important to note that the Orange Book is not Federal law, and is only intended
as a guide to states as they enact their own substitution laws and regulations

7 HIPAA Privacy Regulations

Under the Health Insurance Portability and Accountability Act (HIPAA), the general rule is to keep a
patient's health care information confidential. You cannot use or disclose a patient’s health care
information for purposes other than providing health care to the patient, obtaining payment for the
health care services provided, or in connection with the day to day operations of the pharmacy.
HIPAA applies to “covered entities”
• Health care providers (e.g., pharmacies)
• Health plans
• Health care clearinghouses

2.37.1 Information Covered by HIPAA

HIPAA provides protection against the use and disclosure of “protected health information” (“PHI”)
which is patient information that:
• Is created or received by a covered entity
• Relates to an individual’s past, present or future physical or mental health condition; and
• Identifies the individual or creates a reasonable basis to believe that the information can be used to
identify the individual.
Individually identifiable health information transmitted in any form – on paper, electronically or even
orally – is protected.

2.37.2 HIPAA Requirements

• Notifying patients about their privacy rights, and about how their information can be used by the
pharmacy, which is detailed in the Notice of Privacy Practices (NOPP);
• Ensuring that pharmacy personnel comply with HIPAA, by adopting and implementing procedures
for its pharmacy practice, and training employees
• Designating a privacy officer
• Securing patient records that contain individually identifiable health information and ensuring that
they are only available to those who need access to them

2.37.3 Notice of Privacy Practices

The pharmacy must provide a NOPP to all patients, at the time that the pharmacy service is first
provided to the patient. The pharmacy is required to make a “good faith” effort to obtain a patient’s
written acknowledgment of receipt of the NOPP. The written acknowledgment can take the form of a
 signature log, kept at the pharmacy counter, which cannot be combined with a log used for other
purposes, such as documenting a patient’s refusal to accept an offer of counseling. Once obtained,
the acknowledgement is to be maintained in the pharmacy for a period of six (6) years. If a patient
refuses to sign an acknowledgment, or if the pharmacy is unable to obtain a signed authorization
despite its good faith effort, then the pharmacy must make a record of that fact, and maintain that
record for a period of six (6) years.
The NOPP must contain the following mandatory statement, displayed in a prominent manner on the
face of the document:
THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND
DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT
CAREFULLY.
The NOPP must convey the following information to the patient:
• Description and at least one example of how the pharmacy will use the patient’s PHI;
• Statement of the types of uses and disclosures that require prior authorization from the patient;
• Statement advising the patient that the pharmacy is required to maintain the confidentiality of PHI;
• Statement of the patient’s rights under HIPAA, including the right to request restrictions on the
disclosure of PHI, the right to access the PHI, the right to request amendments to PHI maintained by
the pharmacy, and a right to obtain an accounting of certain disclosures of PHI made by the
pharmacy;
• Statement that patients may complain to the federal Department of Health and Human Services
(“HHS”) if the patient believes that his or her HIPAA rights have been violated; and
• Identity of the pharmacy’s “privacy officer”

2.37.4 Uses and Disclosures

After providing the NOPP, the pharmacy can use and disclose PHI without obtaining any
consent or patient authorization, as long as the use and disclosure is for purposes of
“treatment”, “payment”, or “health care operations” (TPO). Fortunately, the overwhelming
majority of uses and disclosures of PHI that occur in a pharmacy will fall within these three
categories of activities.
Treatment includes all activities associated with filling prescriptions or medication orders, including
discussions concerning the drug therapy with prescribers and other health care professionals, DUR
activities, and dispensing the medication to the patient.
Payment includes all communications required to obtain payment or reimbursement for the
dispensing activities, including obtaining prior authorization from third party payers, claims
submissions, and providing information to payers concerning the patient’s diagnosis and the use of
the drug or the need for drug therapy.
Health care operations are activities required for the day to day operations of the pharmacy,
including record keeping, preparation and review of quality assurance reports, and risk management
activities, etc.

2.37.5 Patient Authorizations

The use or disclosure of PHI for any purpose other than TPO will require the pharmacy to
obtain written authorization from the patient before the PHI is used or disclosed (e.g.
marketing). If a patient refuses to sign an authorization, the pharmacy is prohibited from using or
disclosing the information, and the pharmacy may not condition treatment on the receipt of an
 authorization. For example, if you wanted to obtain a patient authorization so that you could engage
in marketing activities, but the patient refused to sign it, then you would be precluded from refusing
to fill that individual's prescriptions.
The authorization must be a separately signed and dated document and must contain the following
information:
• Specific and meaningful description of the PHI to be used or disclosed;
• Name(s) or specific identification of the person(s) or entities to whom the PHI will be disclosed;
• Description of each purpose for which PHI will be used or disclosed;
• Expiration date or event after which the authorization will no longer be valid; and
• Patient’s signature and the date signed.

2.37.6 Limitations on Use and Disclosure

The privacy rules impose certain limitations on the use and disclosure of PHI when a written
authorization is not required. The rules provide that a pharmacy must make reasonable efforts to
limit the use or disclosure of PHI to the minimum amount required to accomplish the purpose of the
use or disclosure. This “minimum necessary” standard does not apply to disclosures for treatment
purposes, disclosures to the patient themselves, or to disclosures made pursuant to a written
authorization from the patient. The pharmacy also needs to take reasonable steps to ensure that
access to PHI is limited only to those persons who have a right to access PHI. Examples include
having locked prescription files and shredding paper PHI records that are being discarded.

2.37.7 Patient Rights under HIPAA

The privacy rules impose certain limitations on the use and disclosure of PHI when a written
authorization is not required. The rules provide that a pharmacy must make reasonable efforts to
limit the use or disclosure of PHI to the minimum amount required to accomplish the purpose of the
use or disclosure. This “minimum necessary” standard does not apply to disclosures for treatment
purposes, disclosures to the patient themselves, or to disclosures made pursuant to a written
authorization from the patient. The pharmacy also needs to take reasonable steps to ensure that
access to PHI is limited only to those persons who have a right to access PHI. Examples include
having locked prescription files and shredding paper PHI records that are being discarded.

2.37.8 Marketing
In the context of the HIPAA regulations, "marketing" is defined as: To make a communication about
a product or service that encourages recipients to purchase or use the product or service, except:
• For the treatment of the individual
• Face to face communications
• For case management or care coordination
• To direct or recommend alternative treatments, therapies, health care providers, or settings of care
• Health-related services offered by pharmacy or health plan
If any financial remuneration occurs, then even treatment- related communications would constitute
marketing.
Marketing is the quintessential example of where an authorization would be required in order for a
pharmacy to share an individual's PHI. The important thing to remember is that is not inherently
wrong to make money by sharing information (e.g. a pharmacy selling its list of diabetes patients to a
company that wants to market diabetic products). The most important thing is for the pharmacy
never to share PHI in this context without a signed patient authorization.
 2.37.8.1 Refill Reminder Exception:
It is not considered marketing if financial remuneration received that is reasonably related to costs of
making a refill reminder communication to the patient. However, any financial remuneration from a
drug company beyond the cost of providing the reminders would require an authorization.

2.37.9 Penalties for Violations of HIPAA

Under HIPAA, the federal government is permitted to impose civil penalties, as well as criminal
penalties, for non-compliance.
Non-compliance can result in civil penalties of up to $100 per violation and up to $25,000 per person
in any calendar year for the improper disclosure of PHI. If the disclosure was done intentionally, or
with knowledge that the information was protected, but was nevertheless disclosed, criminal
sanctions can be imposed. Penalties for an individual that knowingly permits uses or discloses PHI
improperly can be as harsh as a $50,000 fine, and up to one year in jail.
If an individual uses PHI under false pretenses, the penalty can increase to $100,000 and/or up to
five years in jail. Finally, fines of up to $250,000 and/or ten (10) years in prison can be imposed
where the covered entity uses PHI for “commercial advantage, personal gain or malicious
harm.”

2.37.10 Updates to HIPAA

Since the HIPAA privacy rules went into effect, there have been a number of updates, a summary of
which is listed below. Remember that the HIPAA regulations will supercede any contrary State law
that is contrary to it, but they do not preempt a State law that is more stringent.
• Breach notification requirement: A breach is the unauthorized acquisition, access, use, or
disclosure of PHI, including electronic PHI. Previously, breaches only needed to be reported if they
posed a risk of financial, reputational, or other harm to the affected individuals.Now all cases of
impermissible acquisition, access, use, or disclosure of PHI are presumed to cause harm and be
reportable unless the covered entity or business associate can demonstrate that there was a low
probability that PHI was compromised. Pharmacies will be expected to provide documentation for all
of how they handled these situations, and how they evaluated the probability that the PHI was
compromised.
• Expanded liability for violations: Now business associates of covered entities are held to many of
the same rules and are now liable for violations. Business associates are any entity that creates,
receives, maintains, or transmits PHI. For example, billing services, prescription software vendors,
data archive companies, and companies that destroy used labeled prescription vials have to be
HIPAA compliant. A pharmacy can still be held liable for the acts of its business associates, and
business associates can be held liable for the actions of its subcontractors.
• More limitations on the use of PHI for marketing and the sale of PHI: Patient authorization will
be required for any patient communication that encourages the purchase or use of a product or
service and any activity that involves the sale of PHI. In addition, limits will be placed on the funding
of patient care activities by a third party. Previously, most written communications to patients were
considered under the heading of treatment and were okay without authorization.
• Expanded patient access to their health information: Patients now have the right to receive
electronic copies of their health information if they request it in that format. They’ll also have the right
to restrict disclosures about their treatment to a health plan when they’ve paid (in full) out of pocket.
• Relaxed rules on sharing of immunization records: Copies of a child’s immunization records can
be shared with their school based on a parent request. This won’t require a signed authorization, but
it’s still a good idea to document the request in the child’s record.
 2.37.11 Enforcement
HIPAA is enforced by the office of Civil Rights. Formerly, the OCR responded only to
complaints. Now the agency is taking a pro-active stance to check compliance. In particular the
OCR is checking the documentation for any breach notification as noted above. Pharmacies would
be well-advised to comply with this requirement.

Written acknowledgment of a patient's receipt of the NOPP must be retained by the

pharmacy for 6 years

Signed patient authorizations must be kept on file at the pharmacy for six
(6) years.

2.38 Medicare Conditions of Participation (LTCF)

For the complete listing of conditions of participation related to pharmacy services for a LTCF,
please refer to 42 CFR § 483.60
• Must provide pharmaceutical services (including procedures that assure the accurate acquiring,
receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each
resident
• Must employ or obtain the services of a licensed pharmacist who—
• Provides consultation on all aspects of the provision of pharmacy services in the facility;
• Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to
enable an accurate reconciliation;
• Determines that drug records are in order and that an account of all controlled drugs is maintained
and periodically reconciled.
Drug regimen review.
• The drug regimen of each resident must be reviewed at least once a month by a licensed
pharmacist.
• The pharmacist must report any irregularities to the attending physician and the director of nursing,
and these reports must be acted upon.
Labeling of drugs and biologicals. Drugs and biologicals used in the facility must be labeled in
accordance with currently accepted professional principles, and include the appropriate accessory
and cautionary instructions, and the expiration date when applicable.
Storage of drugs and biological:
• Must store all drugs and biologicals in locked compartments under proper temperature controls, and
permit only authorized personnel to have access to the keys.
Must provide separately locked, permanently affixed compartments for storage of controlled drugs
listed in Schedule II and other drugs subject to abuse, except when the facility uses single unit
package drug distribution systems in which the quantity stored is minimal and a missing dose can be
readily detected
 The LTCF reviewing pharmacist must report any irregularities to the attending
physician and the director of nursing, and these reports must be acted upon.

2.39 Medicare Conditions of Participation (Hospital)

For the complete listing of conditions of participation related to pharmacy services for a hospital,
please refer to 42 CFR § 482.25
The institution must have a pharmacy directed by a registered pharmacist or a drug storage area
under competent supervision. The medical staff is responsible for developing policies and
procedures that minimize drug errors. This function may be delegated to the hospital's organized
pharmaceutical service.
Pharmacy management and administration
• A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and
coordinating all the activities of the pharmacy services
• The pharmaceutical service must have an adequate number of personnel to ensure quality
pharmaceutical services, including emergency services.
• Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.
Delivery of services
• All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision
of a pharmacist and performed consistent with State and Federal laws.
• All drugs and biologicals must be kept in a secure area, and locked when appropriate.
• Drugs listed in Schedules II, III, IV, and V must be kept locked within a secure area.
• Only authorized personnel may have access to locked areas.
• Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient
use.
• When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or
storage area only by personnel designated in the policies of the medical staff and pharmaceutical
service, in accordance with Federal and State law.
• Drugs and biologicals not specifically prescribed as to time or number of doses must automatically
be stopped after a reasonable time that is predetermined by the medical staff.
• Drug administration errors, adverse drug reactions, and incompatibilities must be immediately
reported to the attending physician and, if appropriate, to the hospital-wide quality assurance
program.
• Abuses and losses of controlled substances must be reported, in accordance with applicable
Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief
executive officer, as appropriate.
• Information relating to drug interactions and information of drug therapy, side effects, toxicology,
dosage, indications for use, and routes of administration must be available to the professional staff.
• A formulary system must be established by the medical staff to assure quality pharmaceuticals at
reasonable costs.

2.40 Tamper Resistant Medicaid Prescriptions

Medicaid Prescriptions are now required to be tamper-resistant, which means that the prescription
must meet the following three characteristics:
• Prevent unauthorized copying of completed or blank prescription forms
• Prevent erasure or modification of information written on the prescription
• Prevent the use of counterfeit prescription forms
There is a wide array of current technologies to accomplish these objectives, including but not
limited to microprinting, (i.e., small print which will be shown with magnification, but not upon
copying); serial numbers on prescriptions; coin rubs which will show language upon rubbing with a
coin; watermarks; specialized paper to detect erasure; heat sensitive paper that will reveal a picture
upon the touch of a finger; the word “void” showing if the Rx is copied; and warning messages that
describe security features; etc.
Click here for a graphic display of examples for each of the 3 security features described above.

NJ prescription pads comply with the tamper resistant requirements. The specific
security features of the NJ prescription blank are addressed in the NJ regulations
section.

2.41 Requirements for handling hazardous

materials (USP 800)
To be totally prepared for the MPJE, individuals should read the entirety of USP General Chapter
800. Listed below are some FAQ’s that are posted on the USP website related to Chapter 800. For
additional Q&A's and more information on USP 800, click here.
1.What is the purpose of General Chapter <800>?
The purpose of the chapter is to describe practice and quality standards for handling hazardous
drugs in healthcare settings and help promote patient safety, worker safety, and environmental
protection. The new general chapter defines processes intended to minimize the exposure to
hazardous drugs in healthcare settings.
2.Does General Chapter <800> apply to me?
The chapter applies to all healthcare personnel who handle hazardous drug preparations (e.g.
pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare
workers, veterinarians, and veterinary technicians). The chapter also covers all healthcare entities
that store, prepare, transport, or administer hazardous drugs (e.g., pharmacies, hospitals, other
healthcare institutions, patient treatment clinics, physicians’ practice facilities, and veterinarian
offices).
3.What is a hazardous drug?
A hazardous drug is any drug identified as hazardous or potentially hazardous by the National
Institute for Occupational Safety and Health (NIOSH) on the basis of at least one of the following six
criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans,
organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing
hazardous drugs in structure or toxicity. NIOSH maintains a list of antineoplastic and other
hazardous drugs used in healthcare settings.
4.What is the status of the General Chapter <800> and when will General Chapter <800> become
official?
General Chapter <800> was published on February 1, 2016 in the First Supplement to USP 39–NF
34. The Expert Committee approved a delayed official implementation date of July 1, 2018 to allow
entities additional time to implement the standard. With the delayed official date, entities have more
than two years to implement this new standard.
When reviewing General Chapter 800, it is important to focus on the NABP competency statements
which will test your understanding of appropriate disposal of hazardous materials; training
requirements; environmental controls for the proper storage, handling, and disposal of hazardous
materials; and methods for compounding, dispensing and administration of hazardous materials
 3. PRESCRIPTIVE AUTHORITY
Prescriptive Authority. This table lists the titles and associated abbreviations for those
individuals allowed to prescribe in New Jersey

Title Abbreviation
Doctor of Medicine M.D.
Doctor of Dental Surgery D.D.S.

D.D.M
Doctor of Dental Medicine
Doctor of Veterinary Medicine D.V.M
Doctor of Osteopathy D.O.
Advanced Practice Nurse (limited) authority to prescribe) A.P.N.
Physician Assistant (limited authority to prescribe) P.A.
Optometrist (limited authority to prescribe) O.D.
C.N.M.
Certified Nurse Midwife (limited authority to prescribe)

Don’t forget that each of these health care professionals are required to prescribe
within their scope of practice (e.g., a dentist cannot write a prescription for birth
control pills).

3.1 General Requirements for Written Prescriptions

Written prescriptions shall be issued only on New Jersey Prescription Blanks (NJPB), secured from
an approved vendor and subject to the required security mandates of the prescription blank
program. A practitioner shall include the following information on each written prescription:
• The prescribing practitioner's full name, address, telephone number, license number, and proper
academic degree or identification of professional practice for which licensed
• The full name, age and address of the patient
• The date of issuance
• The name, strength and quantity of the drug prescribed
• Words, in addition to numbers, to indicate the drug quantity authorized if the prescription is for a
Schedule II controlled substance, for example: ten (10) Percodan; or five (5) Ritalin 5 mg
• The number of refills permitted or time limit for refills, or both
• The handwritten original signature of the prescribing practitioner
• An explicit indication, by initials placed next to "do not substitute" if it is the prescribing practitioner's
intention that a specified brand name drug be dispensed
• The prescribing practitioner's D.E.A. number, if the drug is a controlled substance; and
• Adequate instruction for the patient as to frequency; a direction of "p.r.n." or "if needed" alone may
be used if appropriate
A prescribing practitioner shall advise each patient by adequate notice, for example, by a sign or
pamphlet in the waiting room of the office that the patient may request the practitioner to substitute a
generic drug for any brand name drug prescribed.
Each practitioner shall use only written prescription blanks which shall be imprinted with the words
"substitution permissible" and "do not substitute," with a space for the prescribing practitioner's
initials next to the chosen option, and which shall not include preprinted information designed to
discourage or prohibit substitution.
When using health care facility or multi-prescriber prescription blanks, the full name and license
number of the prescribing practitioner shall be legibly printed at the top of the prescription or the
identity of the prescriber shall be designated by a checkmark or other legible means.
Each prescription for a controlled substance shall be written on a separate NJPB.
A NJPB that contains prescriptions for two or more controlled substances shall be invalid.
A NJPB that contains a prescription for only one controlled substance and contains other
prescription(s) other than another controlled substance shall be valid.

3.2 Use of NJ Prescription Blanks

3.2.1 General Requirements
A practitioner practicing in this State shall use non-reproducible, non-erasable safety paper New
Jersey Prescription Blanks bearing the practitioner's license number whenever the practitioner
issues prescriptions for controlled dangerous substances, prescription legend drugs or other
prescription items. The prescription blanks shall be secured from a vendor approved by the
Division of Consumer Affairs in the Department of Law and Public Safety.
A licensed practitioner practicing in this State shall maintain a record of the receipt of New Jersey
Prescription Blanks. The practitioner shall notify the Office of Drug Control in the Division of
Consumer Affairs as soon as possible but no later than 72 hours of being made aware that any
New Jersey Prescription Blank in the practitioner's possession has been stolen.
Prescription blanks for each prescriber and healthcare facility to be numbered
consecutively and to include the prescriber or healthcare facility National Provider Identifier
(NPI).

3.2.2 NJPB Security Features

In addition, NJPBs be printed with the following security features:
▪ A small “Rx” on the front written in thermochromic (heat-activated) ink that changes color or
disappears as the prescription is handled
▪ A line of microprint on the front that becomes illegible when scanned or photocopied
▪ A hollow “VOID” that is invisible on a genuine prescription blank but will be visible on a scanned or
photocopied prescription;
▪ A unique identification number for each blank; and
▪ A scannable barcode matching the unique identification number that allows the prescription to be
identified in the New Jersey Prescription Monitoring Program.
The new blanks will be green on the front and blue on the back, and will have a complete list of
security enhancements printed on the back. Also, the DEA number can optionally be pre-printed on
the prescription blank.

3.3 Certified Nurse Midwives

A CNM who is authorized to prescribe drugs may prescribe only those drugs which are
characterized in the formulary of drugs established in the clinical guidelines, which are established
between the CNM and the affiliated physician. The formulary may include controlled dangerous
substances.

3.3.1 Prescriptions from Certified Nurse Midwives

The prescription requirements for Certified Nurse Midwives are the same as the general prescription
requirements described in Section 3.1.

3.4 Physician Assistants

3.4.1 General Prescription Requirements
A physician assistant shall provide the following on all prescription blanks
• The physician assistant's full name, professional identification ("PA-C"), license number, address
and telephone number
• The supervising physician's full name, printed or stamped
• A statement indicating whether the prescription is written pursuant to protocol or specific
physician direction. Acceptable abbreviations are "prt" for protocol and "spd" for specific
physician direction
• The full name, age and address of the patient
• The date of issuance of the prescription
• The name, strength and quantity of drug or drugs to be dispensed and route of administration
• Adequate instruction for the patient. A direction of "p.r.n." or "as directed" alone shall be deemed an
insufficient direction
• The number of refills permitted or time limit for refills, or both
• The signature of the prescriber, hand-written
• The words "substitution permissible" and "do not substitute" and shall contain space for the
physician assistant's initials next to the chosen option, in addition to the space required for the
signature and
• The physician assistant's Drug Enforcement Administration (DEA) registration number, if the
physician assistant is authorized to issue CDS
 3.4.2 Controlled Substance Prescription Requirements
A physician assistant may order or prescribe controlled dangerous substances (CDS) if
a supervising physician has authorized a physician assistant to order or prescribe Schedule II, III, IV
or V controlled dangerous substances in order to:
• Continue or reissue an order or prescription for a controlled dangerous substance issued by the
supervising physician
• Adjust the dosage of an order or prescription for a controlled dangerous substance originally ordered
or prescribed by the supervising physician, provided there is prior consultation with the supervising
physician
• Initiate an order or prescription for a controlled dangerous substance for a patient, provided there is
prior consultation with the supervising physician if the order or prescription is not pursuant to a
treatment plan for a terminal illness described below; or
• Initiate an order or prescription for a controlled dangerous substance as part of a treatment plan for a
patient with a terminal illness, which for the purposes of this subparagraph means a medical
condition that results in a patient's life expectancy being 12 months or less as determined by the
supervising physician; and the PA has registered with to order or prescribe CDS’s from the
appropriate State and Federal agencies

3.5 Optometrists
3.5.1 General Prescription Requirements (i.e., for all
prescriptions)
• The prescriber's full name, address, telephone number, license number and academic degree or
identification of professional practice preprinted)
• The full name of the patient
• The date of issuance of prescription
• The signature of the prescriber, hand-written

3.5.2 Additional Prescription Requirements for

Pharmaceutical Agents
• The optometrist's certification number
• The name, strength and quantity of drug or drugs to be dispensed
• Adequate instruction for the patient, which shall include, but not be limited to, duration, frequency
and dosage. The use of "p.r.n." or "as directed" without further instruction shall be deemed
insufficient direction
• The number of refills permitted or time limit for refills, or both
• Every prescription blank shall be imprinted with the words "substitution permissible" and "do not
substitute" and shall contain space for the optometrist's initials next to the chosen option, in addition
to the space required for the signature
• Written prescriptions shall be issued only on New Jersey Prescription Blanks (NJPB), secured from
an approved vendor and with the required security features
 3.5.3 Miscellaneous Requirements
• The optometrist shall advise all patients by sign or pamphlet or similar notice available in a
conspicuous location in the optometrist's office that the patient may request that the optometrist
substitute a generic drug, when available, for any prescribed medication
• The optometrist shall not dispense a prescription as provided for in N.J.S.A. 45:12-1 in an
amount exceeding a 72-hour supply unless the prescription is dispensed at no charge to the
patient. However. there is an exception for medications delivered through a contact lens that can be
dispensed for a larger days' supply and for which a charge can be made.
• All licensees are prohibited from prescribing controlled dangerous substances in Schedule I or II with
one exception. In October 2015, the Optometry Board authorized optometrists to prescribe
hydrocodone combination products regardless of the schedule.

3.5.4 License and Registration Numbers

• If an optometrist has a TPA Certification number that begins with the prefix “27TO,” the optometrist
is certified to prescribe topical pharmaceutical agents only
• If an optometrist has a TPA Certification number that begins with the prefix “27OM,” the optometrist
is certified to prescribe oral medications and topical pharmaceutical agents
• In addition, if an optometrist has a Drug Enforcement Administration (DEA) registration number, the
optometrist is authorized to prescribe Schedule III, IV, and V controlled dangerous substances
(CDS)
• For a further discussion of the license numbers assigned to optometrists, check the October 2014
Board of Pharmacy Newsletter by clicking here.
3.6 Advanced Practice Nurse
APN may prescribe medications, including controlled substances, in all medically appropriate
settings, provided they have met the qualifications established by the Board. Prescribing privileges
are pursuant to joint protocols, which are reviewed, updated and signed at least annually by both the
physician and the advanced practice nurse.

3.6.1 Prescription Blank Requirements

An advanced practice nurse who issues prescriptions in any setting other than in a licensed acute
care or long-term care facility may issue written prescriptions for medications to patients only on
New Jersey Prescription Blanks, which shall include the following information:
• The prescribing advanced practice nurse's full name, designation, as an APN, address, telephone
number, and certification number
• The full name, date of birth and address of the patient
• The date of issuance
• The name, strength, route and quantity of the medication prescribed
• The number of refills permitted or time limit for refills, or both
• A handwritten, original signature
• An explicit indication, by initials placed next to "do not substitute," if a specified brand name drug is
to be dispensed
• The full name, title, address, telephone number, and license number of the collaborating physician
• Words, in addition to numbers, to indicate the drug quantity authorized if the prescription is for a
controlled dangerous substance, for example: "ten (10) Percodan" or "five (5) Ritalin 5 mg"; and
• If the prescription is for a controlled dangerous substance, the advanced practice nurse's DEA
number and instructions as to the frequency of use

3.6.2 Miscellaneous Requirements

An advanced practice nurse who prescribes medication or devices shall advise patients by a sign or
pamphlets in the waiting room of the office that a patient may request a generic drug as a substitute
for a brand name drug prescribed.
When using health care facility or multi-prescriber prescription blanks, the full name and certificate
number of the advanced practice nurse shall be legibly printed at the top of the prescription blank or
the identity of the advanced practice nurse shall be designated by a checkmark or other legible
means.
Note the requirement for "Words, in addition to numbers, to indicate the drug
quantity authorized if the prescription is for a controlled dangerous substance, for
example: "ten (10) Percodan" or "five (5) Ritalin 5 mg." This is a subtle difference
from the general prescription requirements in New Jersey, which apply this
restriction only to Schedule II substances.
 4. PHARMACY ACT
This section on the Pharmacy Act only covers material that may not be further fleshed out in the
Pharmacy Regulations section. If any material is covered in both the Pharmacy Act and the
regulations, it may not be covered in this section. Typically, regulations will be written in more detail
than an Act or a Statute. Covered below are some of the more relevant selections from the
Pharmacy Act. Applicants for licensure are strongly advised to read the complete Pharmacy Act.

4.1 State Board of Pharmacy

The board shall consist of eleven members
• 2 public members
• 1 State executive department member
• 8 pharmacists
Each pharmacist member shall have at least five years of experience in the practice of pharmacy
in this State after licensure. and be licensed and in good standing.and be actively engaged in the
practice of pharmacy in this State.
Each term shall be for five years, and no board member is allowed to serve more than 2
consecutive full terms.
At least one of the pharmacists shall be a chain pharmacist; one shall be a health care system
pharmacist; and one shall own their own practice site.

4.2 Application for License Requirements

To obtain a license to engage in the practice of pharmacy, the applicant shall:
• Have submitted a written application in the form prescribed by the board
• Have attained the age of 18 years
• Be of good moral character
• Have graduated and received a professional degree from a college or school of pharmacy that has
been approved by the board
• Have completed an internship or other program that has been approved by the board, or
demonstrated to the board's satisfaction experience in the practice of pharmacy which meets or
exceeds the minimum internship requirements of the board
• Have successfully passed an examination or examinations as determined by the board; and
• Have paid the fees specified by the board for the examination and any related materials, and have
paid for the issuance of the license

4.3 Different Dosage Form

A pharmacist may dispense a prescription in a different dosage form than originally prescribed if the
pharmacist notifies the prescriber no later than 48 hours following the dispensing of the
prescription, provided the dosage form dispensed has the appropriate drug release rate.
 4.4 Administration of Medication Directly to
Patients;Immunizations
4.4.1 General Rules for Administration
No pharmacist shall administer a prescription medication directly to a patient without appropriate
education or certification. Such medication shall only be for the treatment of a disease for which a
nationally certified program is in effect, or as determined by the board, and only if utilized for the
treatment of that disease for which the medication is prescribed or indicated or for which the
collaborative drug therapy management permits.

4.4.2 Specific Rules for Administration

A pharmacist may administer drugs to a patient 18 years and older. Administration of immunizations
and related emergency medications may be pursuant to:
• Prescription by an authorized prescriber
• Immunization programs implemented pursuant to an authorized prescriber's standing order
• Immunization programs and programs sponsored by governmental agencies that are not patient
specific

4.4.3 Special Rules for Influenza Vaccine

A pharmacist may administer an influenza vaccine to a patient who is seven years of age or
older.
For a patient who is under 18 years of age, a pharmacist shall not administer a vaccine except with
the permission of the patient's parent or legal guardian.
For a patient who is under 12 years of age, a pharmacist shall not administer a vaccine unless
pursuant to a prescription by an authorized prescriber.

4.5 Grossly Unprofessional Conduct

4.5.1 Overview
The initial section describes actions that the Board of Pharmacy deems as grossly unprofessional
conduct. There is another section below that includes actions from another statute that are
incorporated into the pharmacy act that apply to all professions. Since the board has wide
discretion as to the penalty that they may impose for a given infraction, you don't have to worry
about matching up a given action with a prescribed penalty. Moreover, once you review the actions
below in both sections that may lead to refusal, suspension, or revocation, I am sure that you will
agree that they are all fairly intuitive, and you should be able to easily identify them on the MPJE®
exam. Therefore, if you read this section over a few times, I believe that should be sufficient, and
you shouldn't worry about memorizing every infraction.

4.5.2 Actions that the Board of Pharmacy Deems as

Grossly Unprofessional Conduct
The board may refuse an application for examination or may suspend or revoke the certificate of a
licensed pharmacist upon proof satisfactory to the board that such licensed pharmacist is guilty of
grossly unprofessional conduct as listed below:
• Paying rebates or entering into an agreement for payment of rebates to any physician, dentist or
other person for the recommending of the services of any person
• The providing or causing to be provided to a physician, dentist, veterinarian or other person
authorized to prescribe, prescription blanks or forms bearing the pharmacist's or pharmacy's name,
address or other means of identification
• The claiming of professional superiority in the compounding or filling of prescriptions or in any
manner implying professional superiority which may reduce public confidence in the ability, character
or integrity of other pharmacists
• Fostering the interest of one group of patients at the expense of another which compromises the
quality or extent of professional services or facilities made available
• The distribution of premiums or rebates of any kind whatsoever in connection with the sale of drugs
and medications provided, however, that trading stamps and similar devices shall not be considered
to be rebates for the purposes of this act and provided further that discounts, premiums and rebates
may be provided in connection with the sale of drugs and medications to any person who is 60 years
of age or older
• Advertising of prescription drug prices in a manner inconsistent with rules and regulations
promulgated by the Director of the Division of Consumer Affairs, except that no advertising of any
drug or substance shall be authorized unless the Commissioner of Health and Senior Services shall
have determined that the advertising is not harmful to public health, safety and welfare
• Engaging in activities beyond the scope of a collaborative drug therapy management agreement

4.5.3 Rights of the Accused

Before a certificate shall be refused, suspended or revoked, the accused person shall be
furnished with a copy of the complaint and given a hearing before the board. Any person whose
certificate is so suspended or revoked shall be deemed an unlicensed person during the period of
such suspension or revocation, and as those shall be subject to the penalties prescribed in this act,
but that person may, at the discretion of the board, have his certificate reinstated at any time without
an examination, upon application to the board. Any person to whom a certificate shall be denied by
the board or whose certificate shall be suspended or revoked by the board shall have the right to
review that action by appeal to the Appellate Division of the Superior Court.

4.5.4 Actions Applicable to all Professional Licenses that

may lead to Refusal, Suspension, or Revocation
• Has obtained a certificate, registration, license or authorization to sit for an examination through
fraud, deception, or misrepresentation
• Has engaged in the use or employment of dishonesty, fraud, deception, misrepresentation, false
promise or false pretense
• Has engaged in gross negligence, gross malpractice or gross incompetence which damaged or
endangered the life, health, welfare, safety or property of any person
• Has engaged in repeated acts of negligence, malpractice or incompetence
• Has engaged in professional or occupational misconduct as may be determined by the board
• Has been convicted of, or engaged in acts constituting, any crime or offense involving moral
turpitude or relating adversely to the activity regulated by the board. For the purpose of this
subsection a judgment of conviction or a plea of guilty, non vult, nolo contendere or any other such
disposition of alleged criminal activity shall be deemed a conviction
• Has had his authority to engage in the activity regulated by the board revoked or suspended by any
other state, agency or authority for reasons consistent with this section
• Has violated or failed to comply with the provisions of any act or regulation administered by the
board
• Is incapable, for medical or any other good cause, of discharging the functions of a licensee in a
manner consistent with the public's health, safety and welfare
• Has repeatedly failed to submit completed applications, or parts of, or documentation submitted in
conjunction with, such applications, required to be filed with the Department of Environmental
Protection
• Has violated any insurance fraud prevention law or act of another jurisdiction or has been
adjudicated, in civil or administrative proceedings, of a violation of insurance fraud in New Jersey or
has been subject to a final order, entered in civil or administrative proceedings, that imposed civil
penalties under that act against the applicant or holder
• Is presently engaged in drug or alcohol use that is likely to impair the ability to practice the
profession or occupation with reasonable skill and safety. For purposes of this subsection, the term
"presently" means at this time or any time within the previous 365 days
• Has prescribed or dispensed controlled dangerous substances indiscriminately or without good
cause, or where the applicant or holder knew or should have known that the substances were to be
used for unauthorized consumption or distribution
• Has permitted an unlicensed person or entity to perform an act for which a license or certificate of
registration or certification is required by the board, or aided and abetted an unlicensed person or
entity in performing such an act
• Advertised fraudulently in any manner
4.6 Drug Utilization Review
A pharmacist shall conduct a drug utilization review before each new medication is dispensed
or delivered to a patient.
A pharmacist shall conduct a prospective drug utilization review in accordance with the
provisions of this section before refilling a prescription or medication order to the extent he
deems appropriate in his professional judgment.
A pharmacist shall exercise independent professional judgment as to whether or not to dispense or
refill a prescription or medication order. In determining to dispense or refill a prescription or
medication order, the decision of the pharmacist shall not be arbitrary but shall be based on
professional experience, knowledge or available reference materials.

4.7 Duty to Fill

A pharmacy practice site has a duty to properly fill lawful prescriptions for prescription drugs or
devices that it carries for customers, without undue delay, despite any conflicts of employees to
filling a prescription and dispensing a particular prescription drug or device due to sincerely
held moral, philosophical or religious beliefs.

4.7.1 Out of stock situations for drugs or devices that the

pharmacy normally carries
If a pharmacy practice site does not have in stock a prescription drug or device that it carries, and a
patient presents a prescription for that drug or device, the pharmacy practice site shall offer to:
• Obtain the drug or device under its standard expedited ordering procedures
• Locate a pharmacy that is reasonably accessible to the patient and has the drug or device in stock,
and transfer the prescription there in accordance with the pharmacy practice site's standard
procedures
 The pharmacy practice site shall perform the patient's chosen option without delay. If the patient so
requests, the pharmacist shall return an unfilled prescription to the patient.

4.7.2 Situations where the pharmacy does not carry the

drug or device being requested
If a pharmacy practice site does not carry a prescription drug or device, and a patient presents a
prescription for that drug or device, the pharmacy practice site shall offer to locate a pharmacy that is
reasonably accessible to the patient and has the drug or device in stock.

4.7.3 Violations
A person who believes that a violation of this section has occurred may report the violation to the
New Jersey State Board of Pharmacy.

4.8 Out of State Pharmacy Registration

4.8.1 Submissions Required from out of state pharmacy
doing business in New Jersey
Any pharmacy located in another state which ships, mails, distributes or delivers in any manner,
legend drugs or devices pursuant to a prescription into this State, shall register with the board and
provide the board with the following information:
• The location, names and titles of all principal corporate officers
• An annual report containing the location, names and titles of all principal corporate officers. (or within
30 days after any change in same)
• That it complies with all lawful directions and requests for information from the regulatory or licensing
agency of the state in which it is licensed
• That it complies with all lawful directions and requests for information from the New Jersey Board of
Pharmacy
• A copy of the most recent inspection report resulting from an inspection conducted by the
regulatory or licensing agency of the state in which it is located

4.8.2 Additional Requirements

Any pharmacy subject to this section shall, during its regular hours of operation, but NLT five days
per week, and for a minimum of 40 hours per week, provide a toll-free telephone service to
facilitate communication between patients in this State and a pharmacist at a pharmacy who has
access to the patient's records. This toll-free number shall be disclosed on a label affixed to each
container of drugs dispensed to patients in this State.

4.9 Report of Certain Occurences

All licensed pharmacy practice sites shall report to the board the occurrences of any of the following:
• Closing of the pharmacy practice site
• Change of ownership, location, interior site design, permit classification, or PIC of the pharmacy
practice site
• Any significant theft or loss of legend drugs or devices
• Disasters, accidents, or any theft, destruction or loss of records required to be maintained by State
or federal law
• Any pharmacy malpractice liability insurance claim settlement, judgment or arbitration award in
excess of $ 10,000 to which an owner, an employee of, or the pharmacy practice site itself is a party

4.10 Pharmacy Permit

4.10.1 Situations where the board may suspend, revoke,
deny, restrict or refuse to renew the permit of any
pharmacy:
• Findings by the board that any conduct of the permit holder or applicant is violative of any federal,
State or local laws or regulations relating to the practice of pharmacy
• A conviction of the permit holder or applicant under federal, State or local laws for a crime of moral
turpitude or a crime that relates adversely to the practice of pharmacy
• Materially false or fraudulent information contained within any application made to the board or in
any application relating to drug or device prescribing, dispensing or administration
• Suspension or revocation by federal, State or local government of any license or permit relating to
the practice of pharmacy currently or previously held by the applicant or permit holder
• Utilizing a permit to obtain remuneration by fraud, misrepresentation or deception
• Dealing with drugs or devices that are known or should have been known as stolen drugs or devices
• Purchasing or receiving of a drug or device by a permit holder or for use at a pharmacy practice site
from a source that is not licensed under the laws of the State, except where otherwise provided
• Intensive and ongoing failure to provide additional personnel, automation and technology as is
necessary to ensure that the licensed pharmacist on duty has sufficient time to utilize the
professional's knowledge and training and to competently perform the functions of a licensed
pharmacist as required by law
• Violation of any of the provisions of the "New Jersey Controlled Dangerous Substance Act," by the
applicant, permit holder or occurring at the pharmacy practice site; or
• Violations of any of the provisions of the Pharmacy Act by the applicant, permit holder or occurring at
the pharmacy practice site

• 4.11 Immunity from Civil Damages for Reports of

Alleged Misconduct
• A person who in good faith and without malice provides to the board any information
concerning any act by a pharmacist licensed by the board which the person has reasonable
cause to believe involves misconduct that may be subject to disciplinary action by the board,
or any information relating to such conduct requested by the board in the exercise of its
statutory responsibilities or which may be required by statute, shall not be liable for civil
damages in any cause of action arising out of the provision of such information or services.
 5. NEW JERSEY BOARD OF PHARMACY
REGULATIONS
Listed below in this section are summaries of the more relevant selections from the pharmacy
regulations at 13:39. Applicants for licensure are advised to read the complete list of regulations in
their entirety.

5.1 Select Definitions

5.1.1 Immediate personal supervision
• The pharmacist shall be physically present in the compounding/dispensing area when interns,
externs and pharmacy technicians are performing delegated duties
• The pharmacist shall conduct any necessary in-process checks and final check in preparation and
compounding of medications
o Checking of each ingredient used
o Quantity of each ingredient whether weighed, measured or counted
o The finished label, and
o The accuracy and appropriateness of the actions of pharmacy technicians, interns and externs

5.1.2 Pharmacy Technician

• An individual registered with the Board whose responsibilities do not require professional judgment
in the preparation and distribution of medications and who works under the immediate personal
supervision of the pharmacist
• Interns, externs, cashiers, stocking and clerical help are specifically excluded from this definition

5.2 General Provisions

5.2.1 Payment of Penalties (1.4)
• Any penalties levied by the board shall be paid within 15 business days of the finalization of
a penalty letter or final order of the board.

5.2.2 Opportunity to be heard (1.5)

• Any time the board seeks to impose a disciplinary sanction, the licensee may request an
opportunity to be heard.

5.2.3 Failure to complete application process (1.7)

• If an applicant for a permit, license or registration fails to complete the application process
within two years of the date of initial application, the Board shall administratively close the
application.
 5.3 Initial Licensure, Internship, Externship, & Reciprocal
Licensure
5.3.1 Initial Licensure
• 18 years of age; completed application, passport sized photo and official transcript
• Graduated with BS Pharm or Pharm D from ACPE accredited school of pharmacy or deemed
equivalent
• If initial licensure applied for more than 2 yrs after graduation, need to complete internship of
1,440 hours
• Passing grade of not less than 75 on the NAPLEX and the MPJE.
• Need transcript and authorization to test b/4 taking exams
• NABP and MPJE scores are only good for 5 years
• If applicant fails either exam three times, the Board may require remedial courses at an
accredited school or college of pharmacy b/4 retaking
• Good Moral Character (Ongoing Requirement)
o Not presently (within last 365 days) engaged in drug or alcohol use likely to impair practice of
pharmacy
o Not convicted of violating any NJ law or other state relating to CS
o Not convicted of violating any law related to practice of pharmacy
o Not been convicted of moral turpitude
o Not had license or permit suspended or revoked in any jurisdiction that proved violation of laws
related to practice of pharmacy and not currently under suspension

5.3.2 Interns and Externs Definitions

Pharmacy Extern
• Any person in the 5th or 6th college year (or 3rd or 4th professional year) at an ACPE approved
school or college of pharmacy
• Assigned to a training site for the purpose of acquiring accredited practical experience under the
supervision of the school or college at which he/she is enrolled
Pharmacy Intern
• Graduate from ACPE-approved school or college of pharmacy making an application for initial
licensure more than two years following graduation
• Graduate from a school or college of pharmacy in a foreign country that has not been accredited by
ACPE or ACPE-equivalent
• Applied for reciprocal licensure and has not been engaged in the practice of pharmacy for at least
1,500 hours within the two-year prior period

5.3.3 Internship Practical Experience Requirements (2.6)

The 1,440 hours of practical experience required for the successful completion of a pharmacy
internship shall be obtained consistent with the following:
• Completed in no less than 34 weeks and no more than 104 weeks, under the supervision of an
intern preceptor. Each week of practical experience shall consist of no less than 15 hours and no
more than 45 hours
• The intern preceptor and the pharmacy intern shall keep accurate records of the time spent by the
pharmacy intern for credit toward the requirements
• No credit shall be given for hours served as a pharmacy intern prior to the applicant's registration
with the Board and approval of the intern preceptor

5.3.4 Pharmacy Preceptor Requirements (2.6)

• Registered and employed as a pharmacist in the area of practice in which he or she is to be
engaged as a preceptor on a full-time basis for at least two years and is currently practicing in NJ
• Has not been convicted of a crime or offense relating adversely to the practice of pharmacy or a
crime of moral turpitude and has not been the subject of disciplinary action taken by a professional
board (e.g., suspension, revocation, significant limitations)
The Board shall approve an intern preceptor selected by each pharmacy intern prior to the beginning
of the internship. An intern preceptor shall not supervise the training of more than one
pharmacy intern at a time.
The intern preceptor in a pharmacy training site shall provide the Board with a detailed written
report outlining the progress, aptitude and readiness to practice of any pharmacy intern under his
or her supervision at the conclusion of the internship.

5.3.5 Pharmacy Intern Registration Requirements (2.7)

• No person shall be employed as a pharmacy intern until registered with the Board and preceptor
has been approved by the Board
• Criminal Background check required (name, address, and fingerprints)
• Good Moral character (ongoing)
o Not engaged in drug or alcohol use that is likely to impair ability
o No CS convictions
o No practice of pharmacy violations or moral turpitude
o No prior suspensions or revocations in pharmacy practice or actively under suspension or revocation
• Registration valid for two years (may be renewed one time for military service, hardship, illness or
disability)
• Change in an intern preceptor shall require prior Board approval
• Intern preceptor and the pharmacy intern shall notify the Board in writing within 10 days of
a change in the pharmacy training site and/or the termination or resignation of the intern
• Pharmacy intern shall notify the Board in writing within 10 days of any change in his or
her name or address

5.3.6 Reciprocal Licensure (2A.1)

• Limited to those pharmacists who have been duly licensed in mutually reciprocating states
• 18 years of age and application which shall substantiate:
• Evidence that initial license was obtained by examination and that license in good standing
• Not had license in any other state suspended, revoked or restricted (except for failure to renew, or
failure to obtain CE where licensed but not engaged in practice of pharmacy)
• Shall be in good standing with any state in which the applicant is licensed:
• Practiced for at least 1500 hours within the immediately prior two years OR
• Have registered as an intern met the internship requirements within the two year period
immediately prior to application
• Must be of good moral character and undergo a criminal background check
• Shall pass the MPJE with a score of 75, and if fail 3 times, may have to take remedial courses b/4
retaking
• For a pharmacist who is reciprocating from mutually reciprocating jurisdication and who has
graduated from a pharmacy school in a foreign country, the requirements are basically the same,
except the individual also needs to have a valid certification from the FPGEC from NABP
An applicant for initial licensure must now also undergo a criminal background
check.

5.4 Pharmacist Requirements

5.4.1Authorization to Practice; display of license (3.1)
Upon satisfying Board requirements for licensure shall receive an authorization signed by the
Executive Director of the Board granting right to practice pharmacy until license is issued. The
authorizations should be maintained on one's person until the license is issued. When license is
received, display biennial license in principal place of employment. If employed by more than one
pharmacy, maintain wallet license when working outside of principal place of employment.

5.4.2Replacement License (3.2)

Replacement license will be issued upon proof of applicant’s identity, payment of fee, and
reasonable proof of the loss or destruction of original, or upon return of damaged license.

5.4.3 Change of Name (3.3)

Pharmacist shall notify the Board in writing w/in 30 days. Need to submit proof of name change
(e.g., certified copy of court order, marriage certificate). Also need to submit previous license to
board.

5.4.4 Change of Address (3.4)

Pharmacist shall notify the Board in writing w/in 30 days. Failure to notify the Board of any change
in a pharmacist's address of record may result in disciplinary action. Service of any administrative
complaint or other board initiated process at address of record shall be deemed adequate notice.

5.4.5 Reproduction of License Prohibited (3.6)

The biennial license or wallet-sized license issued by the Board to any pharmacist shall not be
reproduced by any means. The biennial certificate shall be maintained at the main place of
employment if the pharmacist is employed at more than one location. Must keep pocket license on
person if working away from main location.
 5.4.6 Biennial license renewal; Administrative
Suspension (3.7)
A pharmacist shall renew his/her license for a period of 2 years from the last expiration date. A
pharmacist who submits a renewal application within 30 days following the expiration of the license
shall submit the renewal fee and a late fee. If renewal after 30 days, shall have license
suspended without a hearing (administrative suspension). Continued practice after suspension =
unauthorized practice of pharmacy and subject to penalties.
No monetary fines shall be imposed on pharmacist for failure to renew if the board does not send a
renewal notice at least 60 days prior to expiration.

5.4.7 Reinstatement from Administrative Suspension (3.8)

If a pharmacist has had his or her license administratively suspended, may apply for
reinstatement within 5 years of license expiration. Must submit renewal application, employment
history, all past due renewal fees, reinstatement fee, and any outstanding penalties imposed by
board. Also requires evidence of having completed delinquent CE credits to a maximum of 5
years. If the license has lapsed for a period of five years or longer, must also pass the MPJE
and NAPLEX.

5.4.8 Reinstatement from Disciplinary Suspension (3.8)

If pharmacist has had license suspended for disciplinary reasons, can apply for reinstatement at
end of suspension period. Need to submit reinstatement application, employment history,
reinstatement fee, renewal fee, and evidence of having complied with all conditions imposed by the
board during the suspension.

5.4.9 Inactive licensure (3.9)

A pharmacist may choose inactive status but then is precluded from working at all during the
applicable biennial period. Can resume the practice of pharmacy in NJ if: a) practiced for 1,000
hrs. in another state in the 2 years immediately prior to seeking reinstatement; b) if less than 1,000
hrs worked in another state within the 2 immediate prior years, then must submit evidence of
completing 30 CE credits during those 2 years; c) if haven’t practiced at all during inactive period,
must submit evidence of 15 hrs of CE per year, to a max of 75 credits. (At least 30 CE credits must
have been earned w/in 2 years immediately prior). In all cases above, a renewal fee is also required.

5.4.10 Steering Prohibited (3.10)

Unlawful for a pharmacist to enter into arrangement with health care practitioner who is licensed to
issue prescriptions for the purpose of directing patients to or from a specified pharmacy or
restraining in any way a patient’s freedom of choice to select a pharmacy.

5.5 Continuing Education Requirements

5.5.1 Credit Hour Requirements (3A.1)
▪ 30 hrs of CE credits earned during previous biennial period
▪ 3 of the 30 CE credits must be earned in pharmacy law applicable to the practice of pharmacy in
New Jersey
▪ At least 10 credits earned through didactic instruction (i.e., interactive) (e.g., live lectures,
telephonic, webinars, etc., as long as the attendee can ask questions, etc.)
▪ 10 credits of CE may be carried over to a succeeding biennial period if earned during the last 6
months of the previous biennial period and were not previously reported
▪ 5.5.2 Criteria for CE credit (3A.2, 3A.3)
Programs or courses by ACPE providers
• No credit for less than one contact hour (50 minutes)
• One half credit for every 30 minutes thereafter
• Completion of entire program is required
Programs or courses previously approved by the board
• A licensee can also seek credit for CE not by an ACPE provider or which is not a program prior
approved by the board by submitting for board review and approval
Graduate course work relevant to practice of pharmacy
• 3 CE credits for each course credit
Teaching and/or research appointments
• 3 CE credits for each new course or program taught or researched
• Max of 6 credits
• Full time teacher or researcher not eligible
Preceptor in externship programs
• 3 CE credits per student
• Max of 6 credits
Preceptor in internship programs
• 3 CE credits per 160 hrs. of work by intern
• Max of 6 credits
Publication of relevant article in peer reviewed journal
• 3 CE credits per article
• Max of 6 credits

5.5.3 Credit hour reporting procedure (3A.4)

▪ Specify on license renewal application the CE hours have been completed
▪ Maintain all related documentation for a period of 5 years

5.5.4 Waiver of CE requirements (3A.5)

▪ At option of the board for military service, hardship, illness, or disability
▪ Request for waiver shall be in writing to the board
▪ Waiver only good for the biennial period requested; i.e., must initiate a new request if the
situation continues

5.5.5 Responsibilities of CE Sponsors (3A.6)

▪ Subject matter relevant to pharmacy
▪ At least one hour in length
▪ Qualified instructor who is:
• BS Pharm or Pharm D with at least 5 years experience
• BS Pharm or Pharm D with expertise in the area
• BS Pharm or Pharm D certified by nationally recognized board or assoc
• Licensed health care professional or other individual with special expertise
▪ Must submit application at least 45 days prior to event. Must not make substantive changes to
approved programs without board approval.
▪ Must monitor attendance and provide attendees with verification of attendance
 • Title, date, and location
• Name of program or presenter
• Name and certificate number of course
• Number of credits awarded
• Name, address, telephone number and signature of sponsor
Sponsor must maintain list of attendees for 5 years.
Pharmacy CE requirements are 30 credits in each biennial period, of which 10 must
be through didactic instruction. “Didactic” instruction means in-person instruction
that is interactive.

Applicants are exempt from the CE requirement during the initial registration period.

No credit allowed for routine business portions of meetings or to sell a product or

promote a business enterprise.

5.6 Pharmacy Permit Requirements

5.6.1 New Pharmacies; Eligibility and Application (4.1)
Permit application shall indicate:
▪ Exact intended location and plan/physical arrangement of Rx area including drive through, and all
contiguous areas even if not part of permitted area, and all areas where drugs are stored
▪ Exact trade name/corporate name
▪ Name and addresses of:
▪ Owners/operators if sole proprietorship, partnership, limited liability partnership, or limited liability
company
▪ All officers and stockholders if the corporation is not publicly traded
▪ All principals duly licensed to write prescriptions if the corporation is not publicly traded
▪ The officers, if a publicly traded corporation
▪ Shall include the name of the pharmacist-in-charge (PIC)
▪ Requires high moral character, and no pending indictment of violations of laws related to practice of
pharmacy or CS laws
▪ Before a permit is issued, the board shall inspect and approve the premises, fixtures, and equipment
of the new pharmacy to ensure compliance with all relevant, statutes, regulations, and ordinances
▪ Once issued, the current permit must be conspicuously displayed

5.6.2 Issuance of Permits; permit renewals (4.2)

A permit holder shall annually submit within 30 days after the permit expiration, a renewal application
and the renewal fee. A permit holder that fails to submit the renewal application within 30 days after
the permit expiration shall submit the late renewal fee in addition to the renewal fee. A permit holder
that continues to engage in the practice of pharmacy with an expired permit shall be deemed to be
engaging in the unauthorized practice of pharmacy.
The Board shall send a notice of renewal to each permit holder, at least 60 days prior to the
expiration of the permit. If the notice to renew is not sent 60 days prior to the expiration date, no
monetary penalty or fines shall apply to the permit holder for any unauthorized practice during the
period following the permit expiration, not to exceed the number of days short of 60 before the
renewal was issued.
 5.6.3 Death of Individual Owner or Partner (4.4)
▪ Permit is terminated and shall be returned to the Board
▪ Estate or heirs of the deceased partner and/or the remaining partners shall comply with board
requirements related to changes in ownership listed below if operation of pharmacy is to be
continued.

5.6.4 Change of Ownership; Asset Acquisition (4.5)

• When a complete change in ownership occurs and none of the current owners retains any
ownership interest, the new owner(s) shall, prior to, or within 10 business days of, such change,
submit to the Board a new permit application and an inventory of the pharmacy's controlled
substances. A new pharmacy permit number shall be issued upon request.
• When a reallocation of ownership interests occurs among existing owners, the owners shall, prior to,
or within 10 business days of, such change, submit to the Board an affidavit explaining the asset
reallocation. A new pharmacy permit number shall not be issued
• When the existing ownership is changed through the addition of a new owner(s) or the subtraction of
an existing owner, the owners shall, prior to, or within 10 business days of, the addition of the new
owner(s), submit to the Board a new permit application. A new pharmacy permit number shall be
issued upon request.
• New ownership shall take custodial ownership of the previous five years of prescription and profile
records and maintain them
• Upon the sale, transfer or acquisition of the business assets of a pharmacy, the person or entity
acquiring such assets shall take custodial ownership of the pharmacy's previous five years of
prescription and profile records and shall ensure that the prescription and profile records are
maintained

5.6.5 Change of Corporate Officers or Stockholders of

Public Companies (4.6)
▪ If change of registered agents or officers or change that involves 10 percent or more of the
outstanding stock of a publicly traded company, the corporation shall file an affidavit with the Board
within 30 days

5.6.6 Change of location and/or address of licensed

premises (4.7)
▪ Shall apply to the Board, at least 30 days prior to such change, for a new pharmacy permit.
• The Board shall issue an amended pharmacy permit
• Before issuing permit, Board shall inspect and approve to ensure compliance
• Shall ensure that the prescription and profile records from the pharmacy's previous location and
address are maintained
• If temporary closing of the pharmacy, you would need board approval for a temporary closing that
lasted more than 48 hours. Otherwise, you would just need to put a sign on the exterior of the
building to inform patrons.
▪ When there is a change in a pharmacy's address but no change in the physical location, the
permit holder shall, within 10 business days of the change in address, submit an explanatory
affidavit to the Board.
 5.6.7 Remodeling of Licensed Premises (4.8)
▪ Where such remodeling entails a change within the premises of the location or size of the
prescription area, or a change in the dimensions of the licensed premises, the permit holder
shall notify the Board at least 30 days in advance
• Shall submit plans for the continuation of operations during the remodeling process which the Board
shall review and approve, and the anticipated date of completion
• If remodeling will result in the temporary closing of the pharmacy, you would need board approval for
a temporary closing that lasted more than 48 hours. Otherwise, you would just need to put a sign on
the exterior of the building to inform patrons.
▪ Shall notify the Board upon completion of the remodeling process. Within 60 days of the completion
of the remodeling, the Board shall inspect and approve to ensure compliance.

5.6.8 Change of Name (4.9)

• Shall apply to the Board, at least 30 days prior to such change, for an amended permit
• The Board shall issue an amended permit bearing the new name upon return of the permit bearing
the previous name to the Board
• If a change in pharmacy name is associated with a change in ownership, the permit holder shall
abide by the change in ownership requirements described above.

5.6.9 Discontinued Pharmacies (4.10)

5.6.9.1 Notice Requirements

Whenever a pharmacy is to be discontinued and closed for any reason, the permit holder shall
immediately send written notification at least 15 days prior to the anticipated closing date to:
• State Board of Pharmacy
• Office of Drug Control
• Drug Enforcement Administration
5.6.9.2 Unanticipated Discontinuations

• Whenever a pharmacy is to be discontinued and closed as a result of an unanticipated

occurrence, such as the death of the permit holder, the permit holder's representative shall send
written notification to the Board, the Office of Drug Control and the Drug Enforcement
Administration, ASAP prior to the actual closing date
5.6.9.3 Disposition of medications upon discontinuation

• All medications, including prescription legend and controlled drugs, should be transferred to the
holder of a current pharmacy permit; a wholesaler; a reverse distributor; and/or a manufacturer.
• All medications not properly transferred shall remain on the pharmacy premises with all licenses and
registrations in effect until such medications are disposed of in the manner prescribed by the Board,
the Office of Drug Control and/or the Drug Enforcement Administration
5.6.9.4 Other required actions upon discontinuance within 30 days of closing

o Remove all drug signs from both the inside and outside of the discontinued pharmacy
o Notify the Board in writing of the location of the previous five years of prescription and patient profile
records
o Return the permit to the Board for cancellation
 5.6.10 Availability of records upon termination of
business (4.11)
When a pharmacy ceases operation as the result of a suspension, retirement or death of the owner,
sale or other cause including insolvency, the permit holder shall make every effort to notify patrons
that they have the right to obtain copies of currently valid prescriptions and/or copies of
their patient profile and the location of the prescriptions and patient profile for a one-year
period following notice, using all of the following methods:
• Notification in writing to the Board
• Publication, once weekly for two successive weeks in a newspaper of a notice advising patrons that
they have the right to obtain copies of their prescriptions and/or patient profile, and the location of
the prescriptions and patient profile for a one-year period following publication
• A sign placed in the pharmacy location informing the patrons that they have the right to obtain copies
of their prescriptions and/or patient profile, and the location of the prescriptions and patient profile

5.6.11 Business Hours; Unauthorized Closing (4.12)

▪ All pharmacies shall be kept open at least 40 hours per week and at least five days per week
▪ If any permanent changes are made in the opening or closing hours of a pharmacy, notify the Board
in writing of these changes within 30 days
▪ A notice shall be conspicuously displayed on the exterior of any pharmacy indicating any
temporary changes in the opening or closing hours of the pharmacy, or indicating a temporary
closing
▪ Any temporary closing of a pharmacy for more than 48 hours shall be reported to and approved
by the Board. Notification to the Board shall include contingency plans for accessing patient
records. Any temporary closing of more than 48 hours without prior Board approval shall result
in the pharmacy being deemed a discontinued pharmacy.

5.6.12 Replacement Permit (4.13)

A replacement permit may be issued by the Board upon payment of a fee and submission of
an affidavit describing the loss or destruction of the permit originally issued, or upon return of
the damaged permit.

5.6.13 Reproduction of Permits (4.14)

▪ May be copied only for state agencies and other business entities with whom the permit holder
does pharmacy related business
▪ Any reproduction of a pharmacy permit by a permit holder for any unlawful purpose shall subject a
permit holder to disciplinary action

5.6.14 Security of Pharmacies and Pharmacy

Departments (4.15)
5.6.14.1 Responsibilities of the Pharmacist on Duty

▪ Keeping the pharmacy or pharmacy department closed and the security system turned on at all
times when not present
• For institutional permit, pharmacy technicians may remain within the permitted premises or dept
when closed and secured, if the pharmacist determines that security will be maintained
• Ensuring that the security of the prescription dispensing area and its contents are maintained at all
times, including the restriction of persons unauthorized from being present in the prescription
dispensing area
▪ Reporting all thefts or diversions of prescription legend drugs and devices and controlled
substances, and any significant loss of prescription legend drugs and devices and CS, to the PIC
and permit holder
5.6.14.2 Responsibilities of the Pharmacist in Charge and the Permit Holder

▪ All entrances to the pharmacy or pharmacy department are capable of being locked and are
connected to a monitored security system
• Audible, visual or electronic signal warning of intrusion
• Back-up mechanism to ensure notification or continued operation if the security system is
tampered with or is disabled
• Only the PIC shall be responsible for the security of the keys and the security system access code
5.6.14.3 Responsibilities of the Pharmacist in Charge and the Permit Holder for theft and diversion

If a theft or diversion of prescription legend drugs or devices or controlled substances, or a

significant loss of prescription legend drugs, devices or controlled substances are reported to the
PIC, the PIC shall notify the permit holder. The PIC and the permit holder shall ensure that:
▪ Written report filed with Board upon discovery of the theft or diversion or the significant loss of
prescription legend drugs or devices
▪ Written report filed with DEA upon discovery of the theft or diversion or any significant loss of
controlled substances. A copy of such report shall be filed with the Office of Drug Control, and
with the Board.
5.16.14.4 Additional Responsibilities of the Pharmacist in Charge and the Permit Holder

▪ Secure area for receiving packages known to contain prescription legend drugs and devices and
controlled substances.
• No prescription drug shall be accepted during the hours the pharmacy or pharmacy department is
closed unless adequate security
• If a drop-off device for prescriptions--one-way and irretrievable
▪ Pharmacy is constructed so as to enable the closing off and securing of the department from the
main store area.(floor or fixed counter to the ceiling)
▪ Medications requiring supervision of a pharmacist, including dispensed medication, remain within
dept when pharmacist not in pharmacy dept;
▪ The pharmacy department has a published telephone number different from that of the
establishment in which the department is located.
▪ The telephone number of the PIC available in the office of the manager
▪ Compliance with any law requiring emergency security key box

5.6.15 Specialized Permits (4.16)

Must provide the Board with an application and a policy and procedure manual, which sets forth
a detailed description of the type of specialized pharmacy services to be provided within the
pharmacy practice and detailed provisions to protect the public welfare

5.6.16 Steering Prohibited (4.17)

Unlawful for a pharmacy permit holder to enter into an arrangement with a practitioner for the
purpose of directing or diverting patients to or from a specified pharmacy for the filling of
prescriptions or restraining in any way a patient's freedom of choice to select a pharmacy
 5.6.17 Centralized prescription handling (4.19)
Central prescription handling entails 2 or more licensed pharmacists sharing responsibility for
performing the 4 component functions of handling a prescription, namely intake, processing,
fulfillment, and dispensing.
May be performed by intake or originating pharmacy (which receives the patient’s or prescribing
practitioner’s request to fill or refill); central processing pharmacy (which engages in prescription
review by performing functions that include but are not limited to data entry, prospective drug review,
refill authorizations, interventions, patient counseling, claims submission, claims resolution, and
adjudication); central fill pharmacy (which fills and/or refills prescriptions which includes preparing
and packaging the medication; and a dispensing pharmacy (which receives the processed
prescription and/or the filled or refilled prescription for dispensing/counseling).
5.6.17.1 Centralized prescription handling requirements

▪ Any or all of the participating pharmacies have a contractual relationship or have the same owner
▪ Prior Board approval is obtained (single application to the board). If pharmacy is located outside
of New Jersey, the pharmacy shall have registered with the Board
• An audit trail is maintained that records and documents the unique and secure user identifier(s)
of the pharmacist(s), pharmacy technician(s), intern(s) or extern(s) and the component
function(s) performed by each, All steps performed by a pharmacy technician, intern or extern shall
be documented in the audit trail. All entries to the audit trail made by a pharmacy technician, intern
or extern shall be reviewed and approved by the pharmacist. When more than one pharmacist is
involved in the component functions of prescription handling, the unique and secure user identifier(s)
of the pharmacist(s) responsible for the accuracy and appropriateness of each component
function(s) shall be recorded in the audit trail. The audit trail and prescription information shall be
maintained or stored in original hard copy form or in any other media that facilitates the reproduction
of the original hard copy and shall be maintained for not less than five years. The oldest four
years of information shall be maintained in such a manner so as to be retrievable and readable
within two weeks. The most recent one year of information shall be retrievable and readable
within one business day. Records not currently in use need not be stored in the pharmacy.
5.6.17.2 Prescription Label when dispensed pursuant to centralized prescription handling

• The brand name, or if a generic, the brand name and the name of the generic in the following form,
with the generic name and brand name inserted as appropriate: "--------- Generic for ---------";
• Strength, where applicable
• Quantity dispensed
• Date dispensed
• CDS cautionary label where applicable
• Patient name
• Prescriber name
• Prescription number
• Directions for use
• “Use by” date (earlier of one year from date of dispensing or mfgr expiration date)
• Applicable auxiliary labels
• Name, address, and telephone number of any or all of the following:
• Intake pharmacy
• Central processing pharmacy
• Central fill pharmacy and/or
• Dispensing pharmacy
The patient name, brand or generic name of the medication, and the directions for use appear
in a larger type, in a different color type, or in bolded type, compared to other info on label
 The patient is provided with written information (can be on label) on who to call for questions (bold,
easy to read, with hours and phone number to call)
5.6.17.3 Additional Requirements

▪ All pharmacies engaged in central prescription handling must maintain a common P&P
manual designating responsibilities, and must also include maintenance of the audit trail
▪ All pharmacies engaged in central prescription handling must share a common electronic file
▪ All pharmacies engaged in central prescription handling are responsible for ensuring that the
prescription has been properly filled
▪ Controlled substances may be filled or refilled consistent with the DEA requirements

5.6.18 Out of State Pharmacy Registration (4.20)

Any pharmacy located in a state other than New Jersey that delivers legend drugs or devices
pursuant to a prescription into the State, or which participates in a central prescription handling
arrangement shall be registered with the Board.
It shall be unlawful for any out-of-state pharmacy not registered with the Board to deliver a
prescription into the State of New Jersey.
5.6.18.1 Application Requirements

▪ The name under which the pharmacy is to be operated, the type of practice in which the pharmacy
will be engaging, the weekly hours of operation for the pharmacy, and a copy of the prescription
label to be used by the pharmacy;
▪ The location, names and titles of all principal corporate officers, if the applicant is a corporation,
or the location, names and titles of any individuals in whom ownership is or will be vested, if the
applicant is not a corporation
▪ The name of the PIC and his or her license number in the state in which the pharmacy is located,
and his or her weekly hours of employment
▪ A dated copy of the most recent inspection report resulting from an inspection of the out-of-State
pharmacy conducted by the regulatory or licensing agency in the state in which the pharmacy is
located
▪ A letter of good standing from the state licensing authority in the state in which the licensed,
permitted or registered out-of-State pharmacy is located; and the application fee
5.6.18.2 Ongoing Notification Requirements

An out-of-State pharmacy registered with the Board shall notify the Board within 30 days of the
following:
▪ Any change in ownership of the individual equity holder(s) or business entity holding the license,
permit or registration to operate the pharmacy
▪ A change of registered agents or officers or a change of stock ownership involving 10 percent or
more of the outstanding stock of a publicly traded corporation holding the permit to operate the
pharmacy
▪ Change in the location of the licensed, permitted or registered pharmacy
▪ A change in the name of the licensed, permitted or registered pharmacy
▪ A change in the PIC
The pharmacy shall notify the Board immediately upon the permanent closing of the
pharmacy or upon the commencement of any action by the licensing authority in the state in
which it is located concerning its license, permit or registration to conduct the
pharmacy. Suspension or revocation of a pharmacy's license, permit or registration in the state in
which it is located shall result in the immediate commencement of proceedings by the Board to
suspend or revoke the out-of-State pharmacy's registration in New Jersey.
 5.6.18.3 Additional Requirements

▪ Inform the Board, upon request, of the results of any inspections or investigations conducted
by the regulatory or licensing agency of the state in which the pharmacy is licensed, permitted or
registered or by a Federal agency, including the filing of any action against the pharmacy by the
agency
▪ Inform the Board, upon request, of any directions to, and requests for information from, the
pharmacy issued by the regulatory or licensing agency of the state in which the pharmacy is
licensed, permitted or registered or by a Federal agency
▪ Comply with directions concerning compliance with this section and any requests for
information issued by the Board
An out-of-State pharmacy registered with the Board shall maintain its record of prescriptions for
patients in the State of New Jersey for a period of not less than five years. The oldest four years
of record information shall be maintained in such a manner so as to be retrievable and
readable within two weeks. The most recent one year of record information shall be
retrievable and readable within one business day.
An out-of-State pharmacy registered with the Board shall, during its regular hours of operation,
but not less than five days per week, and for a minimum of 40 hours per week, provide a toll-
free telephone service to facilitate communication between patients in the State of New Jersey and
a pharmacist who has access to the patients' records. This toll-free number shall be disclosed on a
label affixed to each container of drugs dispensed to patients in the State of New Jersey or
alternatively provided to the patient in the form or written information. The written information
provided to the patient shall be in bold print, easily read, and shall include the hours a pharmacist is
available and a telephone number where a pharmacist may be reached. The telephone service shall
be available at no cost to the pharmacy's primary patient population.

5.6.19 Immunizations (4.21)

This section set forth the requirements for licensed pharmacists authorized to administer vaccines
and related emergency medications, which shall be limited to diphenhydramine and
epinephrine, to eligible patients who are 18 years of age and older:
▪ Pursuant to a prescription by a New Jersey licensed physician for a vaccine, related emergency
medications, and pharmacist administration of the vaccine that is patient specific
▪ In immunization programs implemented pursuant to a New Jersey licensed physician's standing
order for the vaccine, related emergency medications, and administration instructions that are not
patient specific; and/or
▪ In immunization programs sponsored by government agencies that are not patient specific
5.6.19.1 Necessary Qualifications for a Pharmacist to be eligible to administer vaccines

Requires pre-approval by the Board to perform such functions. A pharmacist shall submit
documentation which establishes that he or she has satisfied the following education and training:
▪ Completion of an academic and practical curriculum that includes instruction in (CDC) guidelines
for vaccine administrations, (click here for a copy of the guidelines) including.
• The Occupational Exposure to Bloodborne Pathogens standard (OSHA) (click here for a copy
of the standard)
• CDC Guideline for Infection Control in Health Care Personnel (click here for a copy of the
guidelines)
• Basic immunology
• Communicable or vaccine preventable disease epidemiology
 • Vaccine characteristics, contraindications, monitoring, proper storage and proper handling
• Informed consent
• Pre- and post-vaccine assessment and counseling
• Immunization record management
• Immunization schedules
• Injection techniques
• Emergency responses to adverse events
• Medical waste disposal
• Reporting adverse events
▪ Current certification in
• American Heart Association Basic Life Support (BLS) protocol
• Red Cross Adult Cardiac Pulmonary Resuscitation (CPR) protocol for health care providers,
or
• Course that complies with guidelines created by the International Liaison Committee on
Resuscitation (ILCOR).
▪ At least two hours of continuing education in immunizations in each biennial renewal period.
Documentation which establishes that a licensed pharmacist has satisfied the education and
training requirements shall be maintained at the pharmacy practice site. If the immunization
program is to take place somewhere other than the pharmacy practice site, the documentation shall
be maintained in the licensed pharmacist's possession at the immunization location. Such
documentation shall be made available for inspection by the Board.
Board approval granted pursuant to this section shall be renewed on a biennial basis. A pharmacist
seeking such renewal shall submit documentation which establishes that he or she has satisfied the
CPR type and 2 hour CE requirements.
A physician's standing order shall specify the procedures that shall be followed for the reporting
of adverse events. The licensed pharmacist shall maintain and adhere to a manual of policies and
procedures for dealing with acute adverse events. The policies and procedures manual shall
require, at a minimum, that the pharmacist immediately notify emergency medical personnel and
obtain assistance for the patient when an adverse event requiring the administration of emergency
medications occurs. The policies and procedures manual shall be reviewed annually by the
licensed pharmacist and documented.
Physicians' standing orders shall be maintained in either hard copy or electronic form as provided
below, and shall be available for inspection by the Board at the pharmacy practice site and, if
applicable, at the immunization location.
5.6.19.2 Pharmacist requirements before administering vaccine

▪ Screen the patient using CDC established criteria for each specific vaccine
▪ Counsel the patient and/or the patient's representative about contraindications, proper care of the
injection site, and instructions to contact a physician or emergency care facility in the event of any
adverse reaction
▪ Inform the patient and/or the patient's representative in writing, in specific and readily understood
terms, about the risks and benefits of the vaccine and provide the patient with a vaccine
information sheet published by the CDC
▪ Obtain a signed informed consent form from the patient or the patient's representative which shall
be maintained at the pharmacy practice site. If the immunization program is to take place
 somewhere other than the pharmacy practice site, the signed informed consent forms shall be
maintained in the licensed pharmacist's possession at the immunization location. The signed
informed consent forms shall be maintained in either hard copy or electronic form as provided below.
The informed consent form provided by a licensed pharmacist to a patient shall contain a check-
off box which authorizes the pharmacist to send copies of the patient's vaccine documentation to
the patient's primary care provider, and another check-off box which prohibits the pharmacist from
sending copies of the patient's vaccine documentation to the patient's primary care provider. The
informed consent form shall specify that a patient's failure to select one of the two check-off boxes
shall result in the patient's vaccine documentation being sent to the patient's primary care provider, if
identified.
5.6.19.3 Documentation Requirements

The licensed pharmacist shall document all immunizations he or she performs and such
documentation shall be maintained at the pharmacy practice site. If the immunization program is to
take place somewhere other than the pharmacy practice site, the documentation shall be maintained
in the licensed pharmacist's possession at the immunization location, and then transferred to the
pharmacy practice site. Such documentation shall be retained in either hard copy or electronic form,
and shall be made available for inspection by the Board. Such documentation shall include:
▪ The patient's name, address, telephone number, date of birth, allergies and gender
▪ The vaccine administered, the manufacturer, expiration date, lot number, site of administration, and
dose administered
▪ The date of original order and the date of administration(s)
▪ The name and address of the delegating physician, and the name and address of the licensed
pharmacist administering the dose, and the immunization location, if different from the pharmacy
practice site; and
▪ The name and address of the patient's primary care provider, if provided
The licensed pharmacist shall document in detail and immediately report all clinically
significant adverse events to the delegating physician, and to the primary care provider, if identified
and if authorized on the informed consent form. The licensed pharmacist shall, within 72 hours,
report such events to the appropriate government reporting system.
The licensed pharmacist shall provide a copy of all patient related documentation and a copy
of the signed informed consent form to
▪ Each patient receiving an immunization, or to the patient's representative,
▪ Patient's primary care provider, if provided and if authorized and
▪ Appropriate government reporting system if applicable
All documentation and records required to be maintained by this section shall be maintained in
either hard copy or electronic form for a period of not less than seven years from the date of most
recent entry and shall be supplied to any physician or health care provider upon receipt of a
signed patient release of health information form. All records shall be made available to persons
authorized to inspect them under State and Federal statutes and regulations. The oldest six
years of information shall be maintained in such a manner so as to be retrievable and readable
within two weeks. The most recent one year of information shall be retrievable and readable
within one business day. Records not currently in use need not be stored in the pharmacy, but the
storage facilities shall be secure. Patient records shall be kept confidential.
5.6.19.4 Standing Order Requirements

In the case of immunization programs implemented pursuant to a physician's standing order, a

licensed pharmacist shall be supervised by the delegating physician. Supervision by the
delegating physician shall be deemed adequate if the delegating physician
▪ Is responsible for formulating or approving a standing order, periodically reviewing the order and the
services provided to patients under the order
▪ Is geographically located to be easily accessible to the pharmacy practice site and, if applicable, to
the immunization location
▪ Is available through direct telecommunication for consultation, assistance, and direction
▪ Receives annual status reports on the immunization program as administered by the pharmacist
5.6.19.5 Flu vaccine to children 7 years and older

Pharmacists authorized to administer vaccines may administer flu vaccines to children seven years
of age and older against influenza.
▪ For a patient who is under 18 years of age, must obtain the written consent of the patient’s parent
or legal guardian.
▪ For a patient who is under 12 years of age (and at least 7), may administer the influenza
vaccine only pursuant to a prescription by a licensed physician

5.7 Retail Pharmacy Requirements

5.7.1 Retail Pharmacy Signs (5.3)
Pharmacies shall post sign conspicuously identifying the existence of a pharmacy unless prohibited
by lease or ordinance (if so, furnish copy to Board).
Pharmacy/Pharmacy Dept shall post hours that pharmacy is open and the name of PIC at all
consumer entrances including drive-thru windows and drop-off boxes.
When the premises maintains different hours from the pharmacy department, all advertising,
announcements, signs and statements indicating hours of operation shall clearly and distinctly
indicate the hours that the pharmacy department is open.

5.7.2 Spatial Requirements of Pharmacy Prescription

Area (5.4)
For pharmacies in operation prior to July 1, 1963, the space devoted to the prescription area and
laboratory shall not be less than 10 percent of the main floor area of the pharmacy, and in no
instance shall it be less than 50 square feet. If the main floor area of such pharmacy exceeds 1,200
square feet, the 10 percent requirement does not apply and the minimum requirement for the
prescription area shall not be less than 120 square feet.
Otherwise, the prescription area must occupy a minimum of 150 square feet.

5.7.3 Prescription Counter (5.5)

The free working space shall not be less than 18 inches in width and not less than 12 total feet
in length. This minimum working surface shall be kept clear at all times.

5.7.4 Prescription Area Sink (5.6)

Shall provide hot and cold water and be easily accessible to the Rx counter.
 5.7.5 Adequate Storage (5.7)
All prescription drugs and chemicals shall be maintained under adequate storage conditions,
including proper lighting, ventilation, and temperature control, as recommended by the drug
manufacturer.
If storage conditions are not specified by the drug manufacturer, the prescription drug or
chemical shall be maintained according to the parameters set forth in the Drug Substance
Monographs and Excipients of the United States Pharmacopeia/National Formulary, 2016
edition, Where no specific directions or limitations are provided in the packaging and storage
section of individual monographs or in the manufacturer specifications, the conditions of
storage shall include storage at a temperature maintained thermostatically between 20 and 25
degrees Celsius (68 and 77 degrees Fahrenheit), protection from moisture, and, where
necessary, protection from light.

5.7.6 Minimum equipment and supplies (5.8)

• An up-to-date, comprehensive pharmaceutical reference text(s) and suitable current reference
texts encompassing the pharmaceutical services provided by the pharmacy, drug interactions,
drug product composition and patient counseling. Unabridged electronic versions of such
reference texts shall be acceptable.
• Over the counter Schedule V Record Book or an electronic recording system, if Schedule V
controlled substances are sold without a prescription
• Permanent prescription filing device and patient profile record system
• Storage place of substantial construction, which is capable of being securely locked when the
pharmacist is not present in the prescription dispensing area, for Schedule II controlled substances,
if not dispersed
• Suitable volumetric devices
• A steel spatula and a spatula of rubber or composition
• Refrigerator, to be used only for the storage of pharmaceuticals
• Refrigerator thermometer and, if applicable, freezer thermometer, or temperature monitoring device
to enable control of temperature
• Suitable counting trays or approved counting device;
• Labels
• Auxiliary lab
• Two Drug Utilization Review Council Placards and the 29th edition of the list of "Approved Drug
Products with Therapeutic Equivalence Evaluations," commonly known as the "Orange Book,"
incorporated herein by reference, as amended and supplemented, consistent with Department of
Health and Senior Services rules set forth at N.J.A.C. 8:71-1
• Assorted stock of prescription containers and child safety closures or caps that meet USP/NF
standards on light resistance and tightness; and
• Copies of, or access to, current State statutes and rules relating to the practice of pharmacy
 5.7.7 Minimum Equipment for non-sterile compounding
(5.8)
• Class A prescription balance with a complete set of metric weights or equivalent electronic weighing
device
• A glass mortar and pestle
• Glass funnels
• Stirring rods
• Ointment tile or parchment paper; and
• Suppository mold

5.7.8 Prescription Balances, Scales, Weights and

Automatic Counting Devices (5.9)
All pharmacies shall have all balances, scales, weights and automatic counting devices inspected
and properly sealed every 12 months by the Department of Weights and Measures.
Counting trays or counting devices that meet the requirements above shall be used to count oral,
solid drugs or medications.

5.7.9 Restriction on storage of Prescription Legend Drugs

and Controlled Dangerous Substances (5.10)
Prescription legend drugs, devices and controlled dangerous substances shall not be stored in such
a manner as to be accessible to the public.
Prescription legend drugs, devices and controlled dangerous substances shall be stored only in
areas of the premises that are part of the pharmacy or pharmacy department, except that in a health
care facility, prescription legend drugs, devices and controlled dangerous substances shall be stored
consistent with the requirements of N.J.A.C. 13:39-9.23.
Prescription legend drugs, devices and controlled dangerous substances that are received during
hours the pharmacy or pharmacy department is closed shall be stored consistent with the
requirements of N.J.A.C. 13:39-4.15(b)3 (i.e, adequate security)

5.7.10 Control and monitoring of temperature of

prescription drugs and chemicals (5.11)
All prescription drugs and chemicals shall be stored, filled, dispensed, transported, and/or delivered
to the patient, agent of the patient, or facility or healthcare provider providing care to the patient to
assure and maintain the integrity and stability of the prescription drug or chemical at temperatures as
specified by the drug manufacturer. If the drug manufacturer has not specified the appropriate
temperature, the prescription drug or chemical shall be maintained at a temperature maintained
thermostatically between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit).
A pharmacy shall monitor and record the temperature of the pharmacy permitted area
and refrigerator and, if applicable, freezer, no less than twice daily with an interval of at
least eight hours.
 • Appropriate manual, electro-mechanical, or electronic temperature recording equipment
and/or logs shall be utilized to document proper storage of prescription drugs and chemicals
• A pharmacy shall maintain documentation of the recorded temperatures for two years
• A pharmacy shall calibrate thermometers or temperature monitoring devices at predetermined
intervals according to the manufacturer specifications
A pharmacy that delivers a filled prescription drug or chemical to the patient, agent of the patient, or
facility or healthcare provider providing care to the patient by any method, except when picked up
directly from the pharmacy by the patient or his or her authorized agent, shall, in the professional
judgment of the pharmacist, and in accordance with the pharmacy's policies and procedures, use
adequate methods to ensure temperature controlled conditions are maintained during facility
storage, transportation, and delivery.
• To ensure that temperature control is maintained during delivery, the shipping processes may
include the use of appropriate packaging material or devices according to information provided by
the manufacturer, Chapter 1079 of USP, other recognized publications, or expert qualification
analysis
• When packaging material or devices are used to maintain temperature control during delivery, the
contents of the package shall include instructions to the recipient how to easily detect improper
storage or temperature variation, and instructions how to report the storage or temperature
excursion to the pharmacy
The temperature in a refrigerator and, if applicable, freezer that are used to store prescription drugs
or chemicals must be maintained according to USP standards and guidelines.
The pharmacist-in-charge is responsible for ensuring proper temperature controls for all
prescription drugs and chemicals in the pharmacy permitted area and all prescription drugs and
chemicals that are shipped, mailed, distributed, or otherwise delivered from the pharmacy.
The pharmacist-in-charge shall develop and maintain written policies and procedures to
ensure the proper storage in the pharmacy permitted area of all prescription drugs and chemicals,
and the proper storage when prescription drugs or chemicals are delivered from the pharmacy to the
patient, agent of the patient, or facility or healthcare provider providing care. The written policies and
procedures shall include, at a minimum, the following:
• Monitoring and recording the temperature of the pharmacy permitted area and refrigerator and, if
applicable, freezer
• Maintaining documentation of the recorded temperatures consistent with the requirements of this
section
• Actions to be taken in the event of temperature excursions include, but are not limited to: notification
of appropriate personnel, investigation of all temperature excursions, inspection and disposal, as
applicable, of the stock in question, and corrective actions
o For purposes of this paragraph, a "temperature excursion" means any deviation from the
manufacturer's specifications or, in the absence of manufacturer specifications,
applicable USP standards
• Calibrating thermometers or temperature monitoring devices consistent with the requirements of this
section
• Actions to be taken in the event that the prescription drugs and chemicals do not arrive at their
destination in a timely manner or when there is evidence that the integrity of a drug was
compromised during shipment or delivery
• Training of all personnel who handle, or are responsible for overseeing the handling of, prescription
drugs and chemicals to ensure the appropriate storage and delivery of all prescription drugs and
chemicals, including refrigerated and frozen pharmaceuticals
In the event of a temperature excursion at a permitted pharmacy practice site lasting 24 hours or
more, the pharmacist-in-charge shall immediately notify the Board. Notification shall be made in a
 manner such that notice is received by the Board within 48 hours of becoming aware of the
temperature excursion.
In the event of a temperature excursion lasting 72 hours or more, a pharmacist shall not dispense
any prescription drug or chemical unless the pharmacist verifies with the manufacturer of the
prescription drug or chemical that as a result of the temperature excursion, the drug or chemical has
not been adulterated, is safe and efficacious, and its stability has not been adversely affected.

5.7.11 Prescription Drug Retail Price List (5.13)

A pharmacy shall comply with all requirements imposed by, and all requests for information from, the
Division of Consumer Affairs concerning prescription drug retail price lists as provided in N.J.A.C.
13:45A-32.1 (see below). Failure on the part of a pharmacy to comply with these requirements may
subject the permit holder and/or the pharmacist in charge to disciplinary action.
13:45A-32.1
A pharmacy shall maintain a prescription drug retail price list containing the names of the 150
most frequently prescribed drugs in their most commonly prescribed dosage, made available to
the pharmacy by the Director of the Division of Consumer Affairs. The prescription drug retail price
list shall contain the retail price charged by the pharmacy for each listed drug's most commonly
prescribed dosage, in quantities of 30, 60 or 90 units, if applicable, and shall include the drug's
price per unit. The date when the list was last updated by the pharmacy shall be noted on the list.
A pharmacy shall conspicuously post an advisory statement at or adjacent to the prescription
dispensing area, in the patient waiting area or in any area where prescription drugs are delivered,
which is accessible by the general public, notifying consumers about the following:
• The availability of the pharmacy's prescription drug retail list, the consumer's right to ask for the
current retail price that the pharmacy is charging for any drug on the price list and the availability of
additional prescription drug price information from the Division of Consumer Affairs;
• The right to obtain price comparison information for generic prescription drugs; and
• The need to tell the pharmacist and the consumer's healthcare practitioner about all medications the
consumer may be taking and to ask the pharmacist and the healthcare practitioner how to avoid
harmful interactions between any drugs they may be taking.
A pharmacy shall make a written prescription drug retail price list available to consumers for
review upon request. The list shall be printed in at least 12-point type.
A pharmacy may change the retail price for any of the drugs included on its prescription drug retail
price list at any time, provided the prescription drug retail price list is updated as soon as
possible, but at least weekly, to reflect the new retail price charged by the pharmacy.

5.8 Pharmacist in Charge; Pharmacy Personnel

5.8.1 Pharmacist in Charge (6.2)
No pharmacy shall operate w/o a PIC for more than 30 days. When absent for more than 30
days, the pharmacist in charge and the permit holder shall notify the board and also inform the
board of the interim pharmacist in charge.
A pharmacist shall not assume the responsibilities of a PIC of more than one pharmacy or
pharmacy department simultaneously unless an area within a health care facility is permitted as
both an institutional pharmacy and a retail pharmacy, in which case the health care facility may
 employ one individual to act as the pharmacist-in-charge for both the institutional pharmacy and the
retail pharmacy.
Whenever there is a change of a PIC, an inventory of all CDS shall be performed.
Whenever a pharmacist assumes or terminates the duties of a pharmacist-in-charge, the PIC
and permit holder shall so advise the Board in writing w/in 30 days.
A pharmacist in charge shall be a full time employee, minimum of 35 hrs per week, and shall be
physically present for that amount of time to supervise and ensure that:
▪ Adequate staffing is present
▪ Accurate records of Rx medication received and dispensed are maintained
▪ Policies are in place and followed regarding accurate dispensing and labeling
▪ Security of the prescription area and its contents are maintained at all times
▪ Only pharmacists and interns or externs provide professional consultation with patients and
physicians;
▪ Only pharmacists, interns or externs accept telephone prescriptions and only pharmacists, interns,
externs or pharmacy technicians accept renewal authorizations. Note that a pharmacy technician is
limited to accepting authorization from a patient for a prescription refill, or from a practitioner or his or
her agent for a prescription renewal, to situations where the prescription remains unchanged.
▪ No misbranded, deteriorated, adulterated, improperly stored or outdated drugs or any drugs marked
“sample” are dispensed or stored in pharmacy

5.8.2 Identification Tag (6.3)

All personnel working in the pharmacy except personnel engaging in the compounding of sterile
preparations shall wear an identification tag, which shall include at least the person’s first
name, first initial of last name, and job title. ID tag of an employee in training shall reflect the
status of the employee as a trainee.

5.8.3 Meal or Rest Room Breaks (6.4)

A sole pharmacist on duty may take rest room breaks and 30-minute meal breaks while working
in a pharmacy consistent with the following:
▪ Shall remain in the pharmacy, or in the case of a pharmacy dept, in the pharmacy dept building, and
be accessible for emergencies or counseling if requested
▪ The pharmacy shall remain open during the restroom or meal breaks, provided a pharmacy
employee remains present in the pharmacy, for receipt of new prescriptions and dispensing of
medications that have been checked
▪ Sign shall be posted in dispensing area “Pharmacist on break, but available for emergencies and
counseling”

5.8.4 Prescription Handling by Pharmacy Externs, Interns,

Pharmacy Technicians, Pharmacy Technician Applicants,
or unlicensed or unregistered personnel (6.5)
A pharmacy intern, extern, technician or technician applicant may perform the component functions
of prescription handling. All steps performed by a pharmacy technician, technician
applicant, intern or extern shall be documented in the pharmacy audit trail.
Pharmacy interns and pharmacy externs may assist the pharmacist in performing the
following tasks:
▪ Retrieval of prescription files, patient files, and profiles and other such records pertaining to the
practice of pharmacy
▪ Data entry of prescription medication information, including the original or refill date of the
prescription, the number or designation identifying the prescription, the practitioner's information, and
the name, strength, and quantity of the prescribed medication
▪ The collection of the following demographic information for the patient profile: the name, address,
and telephone number of the patient; the patient's age, date of birth; or age group (infant, child,
adult); gender; any allergies and idiosyncrasies of the patient; and any medical conditions that may
relate to drug utilization; The collection of this demographic information above may be performed by
unlicensed or unregistered personnel.
▪ Transcription of scanned prescription or medication order information into the patient record
▪ Label preparation
▪ The counting, weighing, measuring, pouring, and compounding of prescription medication or stock
legend drugs and controlled substances, including the filling of an automated medication system
▪ Accepting authorization from a patient for a prescription refill, or from a practitioner or his or her
agent for a prescription renewal, provided that the prescription remains unchanged.

5.8.5 Pharmacy Technician Registration (6.6)

An individual wishing to be certified as a pharmacy technician shall:
▪ Be 18 years of age or older
▪ Possess a high school diploma or its equivalent
▪ Submit a certification attesting proficiency in written and spoken English
▪ Apply to the Board for registration and submit the application fee
▪ Submit his or her name, address and fingerprints for purposes of a criminal history background
check
▪ Submit evidence of good moral character meaning:
• Is not presently engaged in drug or alcohol use that is likely to impair the ability to practice as
a pharmacy technician ("presently" means at the time of application or any time within the
previous 365 days);
• Has not been convicted of violating any law of this State or any other state of the United
States relating to CDS or other habit-forming drugs;
• Has not been convicted of violating any law relating to the practice of pharmacy;
• Has not been convicted of a crime involving moral turpitude; and
• Has not had his or her authority to engage in the activity regulated by the Board suspended or
revoked as a result of any administrative or disciplinary proceedings in this or any other
jurisdiction pertaining to practice of pharmacy

5.8.6 Pharmacy Technician Applicant

Any person who is hired as a pharmacy technician who is not registered with the Board shall be
designated a pharmacy technician applicant. A person may only be considered a pharmacy
technician applicant one time and only for a maximum of 180 consecutive days.
During the first 10 days of employment, the pharmacy technician applicant shall file an application
with the Board to begin the pharmacy technician registration process.
A pharmacy shall not employ as a pharmacy technician applicant any person who was
previously employed as a pharmacy technician applicant at a pharmacy in the State and who failed
to complete the pharmacy technician registration process or any person who has been
the subject of disciplinary action by the Board.
5.8.7 Authorization to Practice as a Pharmacy Technician;
Display of Registration (6.7)
An applicant for registration as a pharmacy technician who has successfully satisfied all Board
requirements for registration and has been approved by the Board to be registered shall receive an
authorization signed by the Executive Director of the Board granting the applicant the right to
practice as a pharmacy technician in the State of New Jersey until initial registration may be
issued.
Upon issuance, the current biennial renewal registration shall be conspicuously displayed in the
registered pharmacy technician's principal place of employment.
A registered pharmacy technician who is employed by more than one pharmacy in the State shall
maintain the wallet-sized registration issued by the Board on his or her person when he or she is
working at a location where his or her current biennial renewal registration is not on display.

5.8.8 Replacement of Technician Registration (6.8)

A replacement initial registration or renewal registration shall be issued by the Board upon payment
of a fee and upon submission of proof of the applicant's identity and reasonable proof of the loss or
destruction of the initial registration or renewal registration, or upon return of the damaged initial
registration or renewal registration to the Board.

5.8.9 Technician Change of Name (6.9)

If a registered pharmacy technician legally changes the name under which he or she has been
practicing as a pharmacy technician, the pharmacy technician shall notify the Board within 30
days of such change. When a replacement registration is issued, the initial registration shall be
returned for cancellation.

5.8.10 Technician Change of Address of Record; service

of process (6.10)
A registered pharmacy technician must notify the Board in writing of any change in his or her
address of record within 30 days of such change. Failure to notify the board may result in
disciplinary action.

5.8.11 Verification of Technician Registration (6.11)

A verification that the registration of a pharmacy technician is in good standing shall be supplied by
the Board upon written request and payment of fee.

5.8.12 Reproduction of Technician Registration

Prohibited (6.12)
The initial registration, biennial registration or wallet-sized registration issued by the Board to any
pharmacy technician shall not be reprinted, photographed, photostated, duplicated or reproduced.

5.8.13 Biennial Technician Registration Renewal;

Administrative Suspension (6.13)
A pharmacy technician shall renew his or her registration for a period of two years from the last
expiration date. The pharmacy technician shall submit a renewal application to the Board, along with
 the renewal fee prior to the date of registration expiration. A pharmacy technician who submits a
renewal application within 30 days following the date of registration expiration shall submit the
renewal fee, as well as a late fee. A pharmacy technician who fails to submit a renewal
application within 30 days of registration expiration shall have his or her registration suspended
without a hearing. Such suspension shall be deemed an administrative suspension.

5.8.14 Reinstatement from Administrative and

Disciplinary Suspension of a Pharmacy Technician’s
Registration (6.14)
5.8.14.1 Reinstatement from Administrative Suspension

A pharmacy technician who has had his or her registration administratively suspended may apply to
the Board for reinstatement following the date of registration expiration. A pharmacy technician
applying for reinstatement shall submit:
▪ A reinstatement application, including an affidavit of employment listing each job held during the
period of registration suspension, including the names, addresses, and telephone numbers of each
employer;
▪ All past due renewal fees and a reinstatement fee and
▪ Any outstanding penalties imposed by the Board.
5.8.14.2 Reinstatement from Disciplinary Action

A pharmacy technician who has had his or her registration suspended pursuant to disciplinary action
taken by the Board may apply to the Board for reinstatement of his or her registration at the
conclusion of the suspension period. A pharmacy technician applying for reinstatement from a
disciplinary suspension shall submit:
▪ A renewal application, including an affidavit of employment listing each job held during the period of
registration suspension, including the names, addresses, and telephone numbers of each employer;
▪ A reinstatement fee and the applicant renewal fee and
▪ Evidence of having met all conditions imposed by the Board pursuant to the disciplinary and/or
reinstatement order(s).

5.8.15 Pharmacy Technician Duties and Pharmacist-

Technician Ratios (6.15)
5.8.15.1 Permissible Duties

Pharmacy technicians and pharmacy technician applicants may assist the pharmacist in the
following tasks:
▪ Retrieving of prescription files, patient files and profiles and other such records
▪ Data entry of prescription medication information, including the original or refill date of the
prescription, the number or designation identifying the prescription, the practitioner's information, and
the name, strength, and quantity of the prescribed medication;
▪ The collection of the following demographic information for the patient profile: the name, address,
and telephone number of the patient; the patient's age, date of birth; or age group (infant, child,
adult); gender; any allergies and idiosyncrasies of the patient; and any medical conditions that may
relate to drug utilization;
▪ Transcription of scanned prescription or medication order information into the patient record;
▪ Label preparation, and
▪ Counting, weighing, measuring, pouring, and compounding of prescription medication or stock
legend drugs and CS, including the filling of an automated medication system
▪ Accepting authorization from a patient for a prescription refill, or from a practitioner or his or her
agent for a prescription renewal, provided that the prescription remains unchanged. The pharmacy
technician or pharmacy technician applicant shall identify himself or herself when accepting
authorization for such refills.
When pharmacy technicians and pharmacy technician applicants are engaged in any permitted
activities, the pharmacist(s) shall be responsible for all the activities of the pharmacy
technicians and the pharmacy technician applicants.
5.8.15.2 Impermissible Duties

Pharmacy technicians and pharmacy technician applicants shall not:

▪ Receive new verbal prescriptions
▪ Interpret a prescription or medication order for therapeutic acceptability or appropriateness
▪ Verify dosage and directions
▪ Engage in prospective drug review or provide patient counseling
▪ Monitor prescription usage
▪ Override computer alerts w/o first notifying the pharmacist
▪ Transfer prescriptions from one pharmacy to another
▪ Violate patient confidentiality (must sign patient confidentiality statement)
5.8.15.3 Normal Pharmacist to Technician Ratio 1:2

There shall be no more than two Pharmacy technicians being supervised by one pharmacist
at any given time. Those personnel who do computer processing of prescriptions are to be included
in the 1 to 2 ratio. A registered pharmacy technician or a pharmacy technician applicant who is
receiving in-service training, which shall not exceed 210 days, shall be excluded from the ratio
during such training. A pharmacist shall not supervise more than 2 persons receiving in-service
training at the same time.
5.8.15.4 Requirements when 1:2 Ratio is exceeded:

▪ Establish written job descriptions; task protocols, and P&P that pertain to the duties performed
by the pharmacy technicians
▪ Ensure and document that all pharmacy technicians who are working when the ratio exceeds 1:2
have:
• Passed the Pharmacy Technician Certification Board’s Pharmacy Technician Certification
Examination and have fulfilled requirements to maintain this status,
• Passed a Board-Approved certification program and have fulfilled requirements to maintain this
status; or
• Completes a program that includes testing and which has been approved by the board as satisfying
the criteria below, which is maintained in a P&P manual. (Completion of this testing would only
qualify the technician to work for the specific pharmacy or corporation).
▪ Ensure that all pharmacy technicians knowledgeable in the established job descriptions, task
protocols, and policies and procedures in the pharmacy setting in which the technicians are to
perform their duties;
▪ Ensure that the duties assigned to any pharmacy technician do not exceed the established job
descriptions, task protocols, and policies and procedures, nor involve any prohibited task
▪ Ensure that all pharmacy technicians receive in-service training before the pharmacy technicians
assume their responsibilities and maintain documentation thereof. A registered pharmacy technician
or a pharmacy technician applicant who is receiving in-service training, which shall not exceed 210
days, shall be excluded from the 1 to 2 ratio during such training. A pharmacist shall not supervise
more than two persons receiving in-service training at the same time.
▪ Provide immediate personal supervision
▪ Provide the Board, upon request, with a copy of the established job descriptions, task protocols, and
policies and procedures for all technician duties
If the pharmacist to pharmacy technician ratio exceeds 1:2, the pharmacy shall maintain a
policy and procedure manual with regard to pharmacy technicians which shall include the
following:
▪ Supervision by a pharmacist
▪ Confidentiality safeguards of patient information
▪ Minimum qualifications
▪ Documentation of in-service education and/or ongoing training and demonstration of competency,
specific to practice site and job function
▪ General duties and responsibilities of pharmacy technicians
▪ Retrieval of prescription files, patient files, patient profile information and other records pertaining to
the practice of pharmacy
▪ All functions related to prescription processing
▪ All functions related to prescription legend drug and controlled substance ordering and inventory
control
▪ Prescription refill and renewal authorization
▪ Procedures dealing with documentation and records required for controlled drug substance and
prescription legend drugs
▪ Procedures dealing with medication errors, including classification of medication errors
▪ Pharmacy technician functions related to automated systems
▪ Functions that may not be performed by pharmacy technicians
▪ A form signed by the pharmacy technician which verifies that the manual has been reviewed by the
technician
The pharmacist in charge shall review at least every two years and, if necessary, amend the
policy and procedure manual. Documentation of the review shall be made available to the Board
upon request.

5.9 Drug Dispensing and Prescription Records

5.9.1 Valid Prescriptions (7.1)
A pharmacist shall only fill a prescription issued by a practitioner licensed to issue prescriptions in
New Jersey and practicing in New Jersey if the prescription is on a New Jersey Uniform
Prescription Blank ( exceptions for faxed and electronic prescriptions).
A pharmacist shall fill a prescription issued by a prescriber licensed to write prescriptions in
another state, territory or possession of the United States, including prescriptions issued at facilities
within or outside of New Jersey that are regulated by the US VA and/or the Department of
Defense. Such prescriptions shall be filled pursuant to NJ law. Such prescriptions shall not be
required to be issued on a New Jersey Uniform Prescription Blank.
Prescriptions, other than those listed above, shall not be filled by a NJ pharmacy

5.9.2 Lack of Information on Original Prescription (7.2)

If a practitioner fails to include on the original prescription any information that he or she is required
to include, the pharmacist shall obtain such information.
If the practitioner has failed to include directions for use and the practitioner cannot be contacted, the
pharmacist shall indicate on the prescription label the words "use as directed" or "as ordered by the
physician" or similar words to the same effect.
 5.9.3 Authorization for Renewal of Prescriptions; new prescriptions
(7.3)
A prescription for medications or devices which may be sold, dispensed or furnished only upon
prescription, shall not be renewed w/o specific authorization of the prescriber, or the practitioner’s
authorized agent, and the prescription may not be refilled after one year from the date of the
original prescription. A pharmacist obtaining authorization from a practitioner's authorized
agent shall document the name and title of the agent.
Prescriptions marked "PRN" or other letters or words meaning refill as needed shall not be
renewed beyond one year past the date the original prescription was issued.
When the renewals listed on the original prescription have been depleted, no additional renewals
may be added to the original prescription. (i.e., a new prescription must be authorized by the
prescriber).
Prescription information obtained from a practitioner shall be documented at the time of receipt as a
new prescription in hard copy form or by direct entry into the electronic prescription records system.

5.9.4 Emergency Dispensing (7.4)

May dispense an emergency supply (no more than a 72-hour quantity) of a chronic maintenance
drug or device in the absence of a current valid prescription, if, in his or her professional judgment,
refusal would endanger the health or welfare of the patient.
The pharmacist must first ascertain to the best of his or her ability, by direct communication with the
patient, that such a medication or device was prescribed for that patient by order of a licensed
practitioner. The pharmacist shall require the patient or caregiver to provide suitable identification.
Such communication shall be documented in the patient profile record system or in the
pharmacy's manual or electronic files.
A pharmacist may dispense an emergency supply of a Schedule II controlled dangerous substance
in the absence of a current, valid prescription upon receipt of oral authorization from a practitioner as
provided under Federal law (discussed previously in the controlled substance section).

5.9.5 FDA Approval Necessary (7.5)

No drug other than a compounded prescription order shall be sold or dispensed until such drug or
medicine has received an approved NDA, ANDA, INDA or other FDA approval, where required.
The storage and dispensing of all investigational new drugs shall be a pharmaceutical service
provided in cooperation with, and in support of the principal investigator. A pharmacy participating in
experimental research shall comply with the Federal Dept of Health and Human Services
regulations, 45 CFR, Part 46, Protection of Human Subjects of Research incorporated by reference
herein, as amended and supplemented, and which is available
at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/.

5.9.6 Required Records and Documents (7.6)

A pharmacy shall maintain an audit trail that records and documents the unique and secure user
identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s) or extern(s) performing the
component functions of each step of prescription handling.(intake, processing, fulfillment, and
dispensing).
• All steps performed by a pharmacy technician, intern or extern shall be documented in the audit trail.
The collection of demographic information for the patient profile is not required to be part of the audit
trail.
• All entries to the audit trail made by a pharmacy technician, intern or extern shall be reviewed and
approved by the pharmacist. When more than one pharmacist is involved in the component
functions of prescription handling, the unique and secure user identifier(s) of the pharmacist(s)
responsible for the accuracy and appropriateness of each component function(s) shall be recorded
in the audit trail.
• Audit trail documentation shall be generated at the time each component function(s) is performed.
Computer systems employed for audit trail documentation shall be designed to identify and
document the unique and secure identifier for all pharmacists, pharmacy technicians, interns and
externs who utilize the system.
All audit trail and prescription information shall be maintained or stored in original hard copy form
or in any other media that facilitates the reproduction of the original hard copy and shall
be maintained for a period of not less than five years.
• The oldest four years of record information shall be maintained in such a manner so as to be
retrievable and readable within two weeks
• The most recent one year of record information shall be retrievable and readable within one
business day

5.9.7 Unique and Secure User Identifiers

Appropriate documentation identifying the unique and secure user identifier of all pharmacists,
pharmacy technicians, interns and externs employed by the pharmacy shall be maintained by the
pharmacy for a period of not less than five years after the last date of employment.
If a pharmacy utilizes a manual system, appropriate documentation identifying the
handwritten initials with the handwritten signature and printed name of all pharmacists,
pharmacy technicians, interns and externs employed by the pharmacy shall be maintained
for a period of not less than five years after the last date of employment.
• The oldest four years of record information shall be maintained in such a manner so as to be
retrievable and readable within two weeks
• The most recent one year shall be retrievable and readable within one business day

5.9.8 Copies of prescriptions and/or patient profile (7.7)

A pharmacy shall immediately comply with the patient's request for copies of prescriptions
and/or patient profile.
Copies of prescriptions issued directly to the patient shall state in letters at least equal in size to
those describing the medication dispensed, the underlined statement: “COPY FOR
INFORMATION ONLY.’’
Presentation of a prescription label or a prescription marked “COPY FOR INFORMATION ONLY’’
shall be for information purposes only. The recipient pharmacist of such copy or prescription label
shall contact the prescribing practitioner or the last dispensing pharmacy to transfer the
prescription.

5.9.9 Transfer of Prescriptions between pharmacies (7.8)

When a patient, the patient's caregiver, or a pharmacy, acting on behalf of a patient or
caregiver requests the transfer of a valid prescription between pharmacies, a pharmacy shall
immediately comply with the patient's request.
Except for controlled substances, a prescription may be transferred between pharmacies,
consistent with this section, for one year from the date the prescription was written, provided refills
of the prescription are available.
 A prescription for a Schedule II controlled substance may not be transferred.
A prescription for a Schedule III, IV or V controlled substance may be transferred between
pharmacies. A prescription for a Schedule III, IV or V controlled substance that has been
transferred shall not be transferred a second time. This prohibition shall not apply to the
transfer of such prescriptions between pharmacies engaged in central prescription
handling pursuant to N.J.A.C. 13:39-4.18(e) and to pharmacies that share a real-time, on-line
database.
5.9.9.1 Duties of the sending pharmacy

A prescription may be transferred between pharmacies for the purpose of refill dispensing
by telephone, or by facsimile or electronic means as provided in provided that:
▪ The sending pharmacy invalidates the prescription on file as of the date the prescription is
transferred and records on the back of the invalidated prescription order or in the electronic system
the following:
• That the prescription has been transferred and the date of transfer
• The name and address or store identifier of the pharmacy to which the prescription was transferred
• The name or personal identifier of the pharmacist, intern or extern to whom the prescription was
transferred
• The initials or personal identifier of the pharmacist, intern, or extern issuing the transferred
prescription order
5.9.9.2 Duties of the receiving pharmacy

▪ The receiving pharmacy, upon receiving such prescription directly from another
pharmacy, records the following:
• The name and address or store identifier and original prescription number of the pharmacy from
which the prescription was transferred
• The name or identifier of the sending pharmacist, intern or extern
• All information constituting a prescription order, as well as:
• Date of issuance of original prescription;
• Original number of refills authorized on original prescription;
• Number of valid refills remaining; and
• Date the prescription was last filled; and
The pharmacist, intern, extern, or technician at the receiving pharmacy informs the patient or
caregiver that the original prescription has been cancelled at the sending pharmacy.

5.9.10 Filing and Storage of Controlled Substance Prescriptions

(7.9)
Prescriptions for all controlled substances listed in Schedule II shall be maintained in a separate
prescription file unless intermingled with prescriptions for controlled substances in Schedules III, IV,
and V as described below.
Prescriptions for all controlled substances listed in Schedules III, IV and V shall be maintained in a
separate prescription file for such controlled substances only or in such form that they are readily
retrievable from other prescription records of the pharmacy. Readily retrievable means that 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 one-inch high and filed either in the prescription file for controlled
substances listed in Schedule II or in the prescription file for non-controlled substances.
If a pharmacy employs an electronic record-keeping system for prescriptions which permits
identification by prescription number and retrieval of original documents by the practitioner's name,
 patient's name, drug dispensed and date filled, then the requirement to mark the hard copy
prescription with a red "C" shall be waived.

5.9.11 Prescriptions Transmitted by Fax (7.10)

A pharmacist may accept a facsimile prescription for dispensing containing all required information
(except for the NJPB which is not required). A pharmacist shall not fill a facsimile prescription
transmitted by anyone other than a practitioner authorized to prescribe medications or the
prescriber’s agent. The facsimile machine used to receive prescriptions shall be located within
the pharmacy prescription area.
A pharmacist shall seek verbal verification of a facsimile prescription from the prescribing practitioner
whenever the pharmacist has reason to question the authenticity, accuracy or appropriateness of the
prescription. A pharmacist may accept verbal verification regarding the authenticity or legibility of a
facsimile prescription from a prescribing practitioner's authorized agent.
The pharmacist shall retain a printed copy of the faxed prescription for a minimum of 5 years (or
electronic reproduction that is readily retrievable and printable).
A pharmacist may fill a Schedule II faxed prescription provided that the original is presented
prior to dispensing, except in the situations described below, in which case the fax will
be accepted as the original when written for pain management:
▪ Schedule II narcotic compounded for pain management for direct administration to a patient by
parenteral, IV, IM, SC, or IS
▪ Schedule II substance for pain management for resident of LTCF
▪ Schedule II narcotic substance for pain management for hospice patient (practitioner or agent
shall note that patient is hospice patient on Rx)
A faxed prescription for Schedules III through V can also serve as the original prescription.

5.9.12 Electronically Transmitted Prescriptions (7.11)

A pharmacist may accept for dispensing an electronic prescription (i.e., computer to computer or
computer to fax) consistent with the requirements of this section.
▪ A pharmacist may not fill an electronic prescription transmitted by anyone other than a practitioner
authorized to prescribe or agent. If the transmission is from the agent, the transmission shall include
the full name and title of the agent.
▪ Permit holder employs adequate security and system safeguards to prevent and detect
unauthorized access, modification, or manipulation
▪ Computer or device used to receive electronically transmitted prescriptions shall be located
within the pharmacy prescription area
▪ Prescription contains all required info except for handwritten original signature and NJPB. The
practitioner's electronic signature or other secure method of validation shall be provided with the
electronic prescription unless the prescription is transmitted by the practitioner's authorized agent.
▪ If transmitted by an authorized agent, the full name and title of the agent shall be included on the
transmission and the agent shall not sign the prescription.
▪ A pharmacist shall seek verbal verification of an electronically transmitted prescription from the
practitioner when there is a question regarding the authenticity, accuracy, or appropriateness of the
prescription. (May accept verification from the practitioner’s agent).
▪ Printed copy or a record of the electronic prescription that is readily retrievable and printable for a
min of 5 yrs.
Two or more permit holders may establish a common electronic filing system to maintain required
dispensing information.
 Nothing in this section shall be construed to preclude the electronic transfer of information between
pharmacies for purposes of transferring prescriptions.
5.9.12.1 Electronically Transmitted Controlled Substance Prescriptions

May fill CII CS prescription transmitted electronically, provided that original Rx presented prior to
dispensing. The electronic prescription can serve as the original prescription.
May fill a Schedule III through V transmitted electronically and the electronic prescription can serve
as the original signed prescription.

5.9.13 Labeling (7.12)

The dispensed container for any product shall bear a permanently affixed label with at least the
following information
▪ The pharmacy name and address
▪ The pharmacy telephone number
▪ The brand name, or if a generic, the brand name and the name of the generic in the following form,
with the generic name and brand name inserted as appropriate: "--------- Generic for ---------";
▪ Strength of the medication (where applicable)
▪ Quantity dispensed
▪ The date upon which prescription medication is dispensed
▪ A CDS cautionary label
▪ The patient name
▪ The practitioner’s name
▪ The prescription number
▪ Directions for use; and appropriate auxiliary labeling
▪ “Use by” date if dispensed in anything but the original manufacturer’s container. The use by date is
the earlier of one year from date of dispensing or expiration date on manufacturer’s container.

5.9.14 Professional Judgment in Dispensing Drugs (7.13)

The pharmacist shall have the right to refuse to fill a prescription if, in his or her professional
judgment, the prescription is outside the scope of practice of the prescriber; or if the pharmacist
has sufficient reason to question the validity of the prescription; or to protect the health and
welfare of the patient.

5.9.15 Advertising and Sale of Prescription Drugs (7.14)

Price quotations for prescription drugs appearing in any advertisement shall stipulate the strength
and quantity. Price quotations shall include:
▪ Usual and customary prescription cost
▪ All services that will add to the price (e.g., delivery charges)
▪ Effective period of advertised price
Any reference to the quality of a drug or its beneficial use is prohibited.
Upon request by any consumer, the pharmacist shall be required to give usual and customary
price information for a non-third party paying customer over the telephone and the effective
period of the price quote.

5.9.16 Restriction on Sale of Schedule V Over-The-Counter

Controlled Substances (7.15)
Limited in quantity during any 48-hour period
 Purchaser be at least 18 years of age
Obtain suitable identification & proof of age where appropriate
Enter sale of a Schedule V substance in the OTC Schedule V Record Book
• Purchaser’s first and last name, street address, city and state
• Name and quantity of the Schedule V substance sold
• Date of sale
• Name or initials of the pharmacist making the sale
5.9.16.1 Restriction on Subsequent Sales of Schedule V Over-The-Counter Controlled Substances

For a second request for a Schedule V substance within a short period of time the pharmacist shall
determine, through direct communication with the purchaser, whether the substance is being used
correctly.
▪ In that regard, the pharmacist shall ascertain how many people are using the substance and
▪ Whether the condition which the substance is being used to treat is improving
For a third request for a Schedule V substance within a short period of time
▪ Advise the purchaser of the substance’s abuse potential and
▪ Caution the purchaser to consult a physician if condition does not improve
For a fourth request for a Schedule V substance within a short period of time the pharmacist shall
determine
▪ How many people are using the substance
▪ Whether continued use will be therapeutic
▪ Whether the purchaser is treating a condition which requires a physician’s consultation
▪ Whether the purchaser is exhibiting signs of drug abuse and
▪ Whether the purchaser is making similar requests of other local pharmacies
If a pharmacist determines that an individual’s request for a Schedule V substance within a short
period of time subsequent to his or her fourth purchase is warranted, the pharmacist shall:
▪ Document justification for the sale in the OTC Schedule V Record Book
▪ In addition, the pharmacist shall recommend that the purchaser consult with a physician for
medical evaluation due to the substance’s abuse potential as well as the potential hazard presented
by the substance’s continued use
If any Schedule V substance is dispensed to one individual more than five times within any 12-
month period, the pharmacist shall:
▪ Obtain oral or written confirmation for continued need from physician
▪ Document such confirmation in the OTC Schedule V Record Book

5.9.17 Return of Prescription Medication (7.16)

Prescription medication incorrectly dispensed to a patient shall be accepted for return by the
pharmacist but shall not be placed back in stock for reuse or resale. Prescription medication
which has been prepared for a patient but which has not been dispensed to the patient may be
placed in stock for re-use provided:
▪ If ok based on stability, expiration, mfgr storage requirements, etc.
▪ Medication shall not be placed in stock containers of different lot numbers and/or with different
expiration dates
▪ Manufacturer stock containers shall not be overfilled
If can’t be returned to original manufacturer’s container, keep in container in which it has been
repackaged. Prior to re-dispensing, such medications shall be placed in a new container with a
new label or the original label shall be removed and the container shall be re-labeled;
▪ In the event of a recall, assume that products in labeled containers w/o lot numbers are included in
the recall
▪ Held medications w/o lot numbers or expiration dates shall not be dispensed beyond six months
originally dispensed, and shall be marked with same use by date as the medication originally
prepared for dispensing

5.9.18 Outdated Drugs or Drugs Marked “Sample’’ (7.18)

No outdated, misbranded, deteriorated or adulterated drugs, or any drugs marked “sample’’ or with
any like designation or meaning shall be placed or maintained in active stock for use or sale.

5.9.19 Patient Profiles (7.19)

A patient profile system must be maintained by all pharmacies for persons for whom prescriptions
are dispensed. (One profile record may be maintained for members of a family living at the same
address and possessing the same family name).
5.9.19.1 Required Information for Patient Profile

▪ The family name and the first name of the patient in the family
▪ The address and telephone number of the patient
▪ The patient’s age, birth date or age group (infant, child, adult) and gender
▪ The original or refill date the medication is dispensed
▪ The number or designation identifying the prescription
▪ The practitioner’s name
▪ The name, strength and quantity of the drug dispensed
▪ Pharmacist’s comments relevant to the patient’s drug therapy
▪ Allergies and idiosyncrasies of the patient and any medical conditions which may relate to drug
utilization, as communicated to the pharmacist by the patient or representative—if none-then
document as such
5.9.19.2 General Requirements for Managing Patient Profile

The pharmacist shall use professional judgment to review and monitor the patient profile, determine
if there should be any adjustment in the original patient information and so indicate the appropriate
change in the patient profile record.
All prescription patients who patronize a pharmacy shall have a profile record as specified by this
section, and the pharmacist shall inquire as to whether other prescription drugs are being
concomitantly utilized in order to establish a current drug history for the patient.
A patient profile record shall be maintained or stored in original hard copy form or in any other media
that facilitates the reproduction of the original hard copy and shall be maintained for a period of
not less than five years from the date of the last entry in the profile record.
If using an electronic data processing system, the system shall have the capability of producing
retrievable and readable documents of all original and refilled prescription data for a period of not
less than five years, including the number of refills authorized by the practitioner.
• The oldest four years of record information shall be maintained in such a manner so as to be
retrievable and readable within two weeks
• The most recent one year of record information shall be retrievable and readable within one
business day
Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store
such records shall be secure. Patient records shall be kept confidential.
 If the pharmacy uses an electronic data processing system, an auxiliary record keeping system
shall be established when the electronic data processing system is inoperative for any reason.
When the electronic data processing system is restored to operation, the patient profile information
and number of refills authorized during the time the electronic system was inoperative shall be
entered into the electronic data processing system within 72 hours.
If an electronic data processing system is used, the system shall provide adequate safeguards
against manipulation and alteration of records and to protect confidentiality of the information
contained in the data bank.
The holder of the pharmacy permit shall make arrangements with the supplier of data processing
services or materials to ensure that the pharmacy will continue to have adequate and complete
prescription and dispensing records if the relationship with such supplier terminates for any
reason.

5.9.20 Drug Utilization Review (7.20)

Upon receipt of a new or refill prescription, a pharmacist shall examine the patient's profile record
before dispensing the medication, to determine the possibility of a potentially significant drug
interaction, reaction or misutilization of the prescription. Upon determining a potentially significant
drug interaction, reaction or misutilization, the pharmacist shall take the appropriate action to
avoid or minimize the problem, which shall, if necessary, include consultation with the patient
and/or the practitioner.
Upon receipt of a refill prescription, a pharmacist shall determine if a substantial time, as is
appropriate for that drug in the pharmacist's professional judgment, has elapsed from the last
filling. When necessary, the pharmacist shall consult with the practitioner and/or the patient to
ensure that continued use of the medication is appropriate.
When patient profile records indicate sporadic, erratic or irrational use of medication by a patient,
the pharmacist shall consult with the patient and/or the practitioner to determine if continued
use of the medication is appropriate.

5.9.21 Patient Counseling (7.21)

Except when a patient refuses counseling, before dispensing a new medication, a pharmacist shall
make reasonable efforts to counsel the patient or the patient's caregiver.
5.9.21.1 Suggested information to consider discussing during patient counseling

Counseling may include the following:

▪ The name and description of the medication
▪ The dosage form, dosage, route of administration, and duration of drug therapy
▪ Special directions and precautions for preparation, administration and use by the patient
▪ Common adverse or severe side effects or interactions and contraindications that may be
encountered, including how to avoid such side effects, interactions and contraindications, and the
action required if they occur
▪ Techniques for self-monitoring drug therapy
▪ Proper storage
▪ Prescription refill information
▪ Action to be taken in the event of a missed dose
5.9.21.2 General Requirements related to patient counseling

The offer to counsel may be made by pharmacy personnel. However, counseling shall be
performed only by a pharmacist, or by a pharmacy intern or pharmacy extern under the
immediate personal supervision of a pharmacist.
A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver
refuses such counseling. The absence of any record of a failure to accept the pharmacist's offer to
counsel shall be presumed to signify that the offer was accepted and that the counseling was
provided.
If the patient or caregiver is not physically present, the offer to counsel shall be made by telephone
or in writing on a separate document accompanying the prescription. A written offer to counsel
shall be in bold print, easily read, and shall include the hours a pharmacist is available and a
telephone number where a pharmacist may be reached. The telephone service must be available
at no cost to the pharmacy's primary patient population.
The counseling requirements shall not apply to a pharmacist who dispenses any drug to an
inpatient at a hospital or a long term care facility in which the resident is provided with 24-hour
nursing care.

Prescriptions marked “prn” or similar wording shall not be renewed beyond one year
past the date of the original prescription.

Computer systems that automatically generate the unique and secure user identifier
of a pharmacist, pharmacy technician, intern or extern without requiring an entry by
the responsible party are prohibited

The fax machine must be located within the prescription area of the pharmacy

The faxed prescription shall contain:

-ID # of transmitting fax machine
-Time and date of transmission
-Name, address, telephone#, and fax # of the Pharmacy
-Name & Title of transmitting agent, if applicable

A pharmacist shall not enter into any agreement with a prescribing practitioner that
requires that facsimile or electronic prescriptions be transmitted to a particular
pharmacy or that denies the patient right to choose a pharmacy.
The name of the pharmacist-in-charge is no longer required on the label.
The patient name, brand or generic name, and the directions for use must be bolded
or in a larger font or different color than the other information on the label.

Any reference in any form of advertisement to the quality of a drug or its beneficial
use is prohibited.

Any advertisement demeaning the quality of professional services rendered by

another licensee or permittee shall be prohibited.

Resolve any doubts about making a CV retail sale against the sale.

“Short period of time” is defined as two to four days from previous sale.

The Patient Profile Record System (PPRS) shall be manual or electronic and enable
the immediate retrieval of information necessary to allow the dispensing pharmacist
to identify previously dispensed medication at the time a prescription is presented
for dispensing.
The requirements to counsel the patient or caregiver upon receipt of a new
prescription shall not apply to a pharmacist who dispenses any drug to an inpatient
at a hospital or a long-term care facility in which the resident is provided with 24 hour
nursing care.

5.10 Pharmaceutical Services for Healthcare Facilities

5.10.1 Purpose and Scope
The rules in this section apply to all retail pharmacies that contract to provide pharmaceutical
services to healthcare facilities and to all institutional pharmacies, as well as institutional pharmacies
filling prescriptions for outpatient use.

5.10.2 Definitions (Partial Listing) (9.2)

"Formulary" means a continually revised compilation of pharmaceuticals available in the pharmacy
for use in the facility developed by the Pharmacy and Therapeutics Committee.
“Health Care Facility” means a facility or institution licensed by the Dept of Health and Senior
Services.
 “Health Care System” means one or more health care facilities which are owned or controlled by
the same legal entity.
“Institutional Pharmacy” means the area in a health care facility or a health care system licensed
by the board as a pharmacy that maintains an institutional permit. It includes any areas of the health
care facility or the health care system where pharmaceuticals are stored, compounded, or
dispensed.
“Medication order’’ means a written request for medication originated by an authorized prescriber
and intended for patient use in the health care facility, and not for use of the institution’s
employees or their dependents or outpatients of the facility’s clinics. A valid medication order
contains the date ordered, the patient’s name and location within the facility, the name, dose, route,
and frequency of administration of the medication, and any additional instructions. Computer-
generated medication orders within an institutional setting, utilizing the practitioner’s electronic
signature or password will meet legal requirements for a prescriber’s original handwritten
signature on medication orders. Computerized signatures or passwords will be accepted provided
that the facility has adequate safeguards which assure the confidentiality of each electronic
signature or password and which prohibit their improper or unauthorized use.
“Pharmacy and Therapeutics Committee’’ means the active standing committee of the institution
or health care facility which is the organizational line of communication and liaison between the
medical service and pharmacists staff and which acts to review and promote rational drug therapy
and utilization in the facility.
“Unit dose packaging’’ means a single unit use non-parenteral medication provided in packaging
which contains the following information for each unit:
▪ Product name
▪ Strength and/or quantity and/or volume, where appropriate
▪ Lot number
▪ Use by date; (i.e., the earlier of one year from the date of packaging or the expiration date on the
manufacturer's container; and
▪ Manufacturer or re-packager, and
▪ If there is more than one product in the single unit, a physical description of each medication n the
single unit

5.10.3 Licensure of Institutional Pharmacies (9.3)

Any institutional pharmacy shall be registered with the Board and possess an institutional
permit issued by the Board, which is conspicuously displayed.
An institutional pharmacy that is part of a health care system may fill medication orders for health
care facilities that are part of the health care system and that provide pharmaceutical services
directly to the patients of the health care system.

5.10.4 Contract Pharmaceutical Services (9.4)

An institutional permit is required for any area within an institution serviced by an outside vendor
that performs on-site pharmaceutical services.

5.10.5 Advisory Committees (9.5)

The pharmacist-in-charge, or designee, shall be an actively participating member on any committees
of the facility that may be concerned with drugs and their utilization.
5.10.6 Pharmacy and Therapeutics Committee (9.6)
In all health care facilities providing pharmaceutical services to patients, an active standing
committee of the institution entitled the Pharmacy and Therapeutics Committee or other
appropriate name shall be established. A Pharmacy and Therapeutics Committee shall be
multidisciplinary and include a pharmacist.
In all health care facilities providing pharmaceutical services to patients that are not required
to maintain a P&T committee, the pharmacist-in-charge of the provider pharmacy, in cooperation
with the health care facility, shall create policies and procedures as needed to provide
pharmaceutical services to the health care facility. Copies of the policies and procedures shall be
made available to the Board upon request.

5.10.7 Control of heath care pharmaceutical services;

responsibilities of the pharmacist in charge of the provider
pharmacy (9.8)
The pharmaceutical services of the health care facility shall be the responsibility of and under the
control, supervision, and direction of the PIC of the provider pharmacy.
If a health care facility does not have an institutional pharmacy on its premises or chooses to
utilize the services of a pharmacy outside the institution, it may enter into an agreement with a
pharmacy licensed by the Board. The PIC of that pharmacy and the designated pharmacist of
the institution, if appropriate, shall direct, control, supervise and be responsible for
the pharmaceutical services provided to the facility.
The pharmacist-in-charge, with the cooperation of the P&T Committee, shall develop written
policies and procedures as needed to provide pharmaceutical services to the facility, which shall
be available to the Board.

5.10.8 Pharmaceuticals; drug supply; investigational drugs;

controlled dangerous substances (9.10)
The PIC shall be responsible for determining the specifications for drugs and pharmaceutical
preparations used as to quality, quantity and source of supply. An authorized purchasing agent
and/or materials manager and/or pharmacy buyer of the facility may perform the actual
procurement. All purchases shall be reviewed by the pharmacist-in-charge or his or her
pharmacist designee.
Written policies and procedures for the maintenance, content, control and accountability of
drugs supplied and located throughout the facility shall be developed by the PIC and approved by
the P&T Committee.
Written policies and procedures for the control, use and accountability of Investigational New
Drugs shall be developed by the pharmacist-in-charge and the P&T Committee. The storage,
labeling and dispensing of all Investigational New Drugs shall be a pharmaceutical service provided
in cooperation with, and in support of the principal investigator.
Written policies and procedures for the control, use and accountability of controlled dangerous
substances shall be developed by the pharmacist-in-charge and the P&T Committee.

5.10.9 Drug Disbursements; Written Orders (9.11)

The pharmacist shall review the practitioner's original order or a copy of the original order generated
by any media that facilitates the reproduction of the original order before any initial dose of
medication is dispensed, except for stat orders as provided for in N.J.A.C. 13:39-9.13.
 Drugs not specifically limited as to time or number of doses when ordered shall be controlled by
the automatic stop order procedure or other methods in accordance with written policies of the
facility.
The P&T Committee shall develop a list of unapproved or unacceptable abbreviations and
symbols which shall not be used in the facility.
When appropriate, the pharmacist shall make necessary entries into the patient medical record
relative to drug use in accordance with health care facility policies, and, where applicable, pursuant
to regulations of the Department of Health and Senior Services and/or CMS.

5.10.10 Drug Disbursement; Oral Orders (9.12)

A pharmacist shall receive oral orders only from an authorized practitioner. Oral orders shall be
immediately recorded and signed by the person receiving the order on the medication order sheet or
into the electronic data processing system.
Oral orders for Schedule II controlled substances shall be permitted only in the case of a bona
fide emergency situation.
The prescriber shall countersign oral orders.
The pharmacist may release to the patient at discharge any remaining medication in a multiple
dose container (for example, inhalers, multiple-dose injectable medications such as insulin, topical
preparation, drops, ointments, and topical irrigation solutions), provided that the pharmacist:
▪ Labels the medication for out-patient use pursuant to labeling requirements for a retail prescription
▪ Counsels the patient prior to discharge from the hospital or medical facility
▪ Ensures that discharge orders contain the attending practitioner’s authorizations to release the
remaining doses of the prescription to the patient or guardian.

5.10.11 Monitoring of Patient Drug Therapy (9.13)

The pharmacist shall be responsible for monitoring drug therapy of patients in the facility including,
but not limited to, maintaining and reviewing the patient medication profile prior to the
dispensing of medications.
STAT orders shall be documented on the patient’s medication profile immediately after
dispensing.
When the pharmacy is closed, these drugs shall be documented on the patient’s medication profile
immediately after the pharmacy is reopened.

5.10.12 Medication Not Dispensed in Finished Form (9.14)

The pharmacist shall be responsible for providing medication in a form that requires little or
no further alterations, preparation, reconstitution, dilution or labeling by other licensed personnel.
The pharmacist shall provide adequate instructions for those products that are not dispensed in
finished form.

5.10.13 Drug Labeling (9.15)

Labeling of medications, other than intravenous solutions, shall be in conformance with written
policies and procedures controlling the drug distribution system in use within the facility and in
accord with current acceptable standards of pharmaceutical practice. Labeling of intravenous
solutions shall be consistent with the labeling requirements set forth in N.J.A.C. 13:39-11
(compounding regulations).
 5.10.14 Use of Patient’s Own Medication (9.16)
No drugs shall be administered to a patient except those provided through the
pharmacy and except as provided by written policies and procedures developed by the
pharmacist-in-charge, or, where applicable, the director of pharmaceutical services and approved
by the P&T Committee.
Although the use of patient’s own medications may be warranted in certain situations, it should
be discouraged as a general or routine practice. If a patient’s previously acquired medication is to
be used, a written order to this effect shall be signed and dated by the patient’s physician. Such
medications shall be identified by the pharmacist as to contents and dispensing origin. Also,
these medications shall be documented as part of the pharmacy’s patient profile record system.

5.10.15 Drug-Dispensing Devices (9.17)

When approved as an integral part of the drug distribution system the device may be used when
the pharmacist is not on duty, provided that any absence of the pharmacist does not exceed 24
hours, or when the pharmacist is on duty, provided that proper review of the use of the drug-
dispensing device can be ascertained. The supervision of any drug-dispensing device so
utilized shall be the responsibility of the PIC servicing the health care facility. The drug-
dispensing device data shall be checked for accuracy every 24 hours by a pharmacist and so
documented.
Packing and labeling of medication for drug-dispensing devices, when done in the facility, shall be
performed under the immediate personal supervision of a pharmacist in the employ or under
contract to the facility.
Stocking and responsibility for the cleanliness of the drug dispensing devices shall be performed
by or under the supervision of a pharmacist.
Controlled substances and other medications to which, in the professional judgment of the
pharmacist-in-charge, access should be limited, shall be secured within the drug dispensing
device to limit access to single medications only and shall be checked and documented by the
pharmacist or his or her designee who shall be a licensed professional, every 24 hours. Other than
a pharmacist only authorized RN’s, LPN’s, practitioners, pharmacy technicians, interns, and externs
shall have access to the medication in each drug-dispensing device. The activity regarding all
medication, including the identity of the person accessing the medication, shall be
recorded and available to the pharmacist.
A medications withdrawn from a drug dispensing device require a medication order by an
authorized prescriber, which shall be checked by the pharmacist within 24 hours from the time of
the original order and so noted on the pharmacy’s patient medication profile.
When there is no licensed pharmacy on the premises, the devices shall be controlled by the
PIC who is responsible for the pharmaceutical services of the institution. Under these circumstances,
the time b/n medication order checks shall not exceed 24 hours.

5.10.16 Disposal of Unused Medications (9.18)

Written policies and procedures governing unused medications shall be established and
implemented by the PIC:
▪ All medications where the drug source, lot or control number or expiration date or use by date
are missing, shall be sent to the pharmacy for final disposition, or shall be disposed of by the
health care facility according to its written protocol
▪ If a unit dose packaged medication has been stored in a medication room or secure area in the
institution and the medication seal and control number are intact, the medication may be
recycled and re-dispensed.
▪ Any and all medication returned by outpatients of the facility shall not be re-dispensed.
The record of disposal of unused or non-administered dispensed controlled dangerous
substances expended or wasted either by accident or intent shall be signed and cosigned and
witnessed by a licensed nurse, physician or pharmacist, or where allowed by the Dept of Health
and Senior Services, an administrator of the health care facility, and disposed of by the health care
facility according to its written protocol.

5.10.17 Records and Reports (9.19)

Records of the pharmaceutical services of the provider pharmacy for the facility shall be
the responsibility of the PIC. A pharmacy shall maintain an audit trail that records and documents
the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s) or
extern(s) performing the component functions of prescription handling. The collection of
demographic information for the patient profile is not required to be recorded in the audit trail.
5.10.17.1 Audit Trail Requirements

▪ All steps performed by a pharmacy technician, intern or extern shall be documented in the audit trail.
▪ All entries to the audit trail made by a pharmacy technician, intern or extern shall be reviewed and
approved by the pharmacist.
▪ When more than one pharmacist is involved in the component functions of prescription handling, the
unique and secure user identifier(s) of the pharmacist(s) responsible for the accuracy and
appropriateness of each component function(s) shall be recorded in an audit trail.
▪ Audit trail documentation shall be generated at the time the component function(s) is performed.
▪ All audit trail and medication order information shall be maintained or stored in original hard
copy form or in any other media that facilitates the reproduction of the original hard copy and shall
be maintained for a period of not less than five years.
• The oldest four years of information shall be maintained in such a manner so as to be
retrievable and readable within two weeks
• The most recent one year of information shall be retrievable and readable within one business
day
5.10.17.2 Patient Profile Requirements

▪ The profile records for inpatients shall contain: the date of each entry; the name; sex; age or
birthdate; location of the patient; the drug name, dose, route of administration and quantity
dispensed; the reported diagnosis, allergies and chronic condition(s) of the patient.
▪ All notations made on the inpatients' profile records by pharmacy technicians, interns and
externs shall be verified and countersigned, either manually or electronically, by the
supervising pharmacist.
▪ The inpatient profile record shall be filed and stored for five years following patient discharge.
▪ The oldest four years of information shall be maintained in such a manner so as to be retrievable
and readable within two weeks
▪ The most recent one year of information shall be retrievable and readable within one business day
5.10.17.3 Adverse Event Records

The PIC shall be responsible for maintaining a system by which all reported adverse drug
reactions are recorded and reviewed by the P&T Committee, where applicable, and are
submitted to all appropriate State and local agencies consistent with State and local laws and
regulations.
 5.10.18 Drug Information and Education (9.20)
The PIC shall be responsible for maintaining drug standards, references and sources of drug
information current and adequate to meet the needs of the pharmacists, physicians, nurses, other
health care personnel, and patients of the facility. Reference texts shall include, but not be limited
to, those required for a retail pharmacy setting.
On each patient care unit, the pharmacist shall maintain the following:
▪ A copy of the current institutional formulary
▪ A reference drug compendium which will give basic information concerning drugs approved by
the P&T Committee
▪ The telephone number of either the local or regional poison control center
The pharmacist shall participate in the drug education programs of the facility.

5.10.19 After Hours Access to the Institutional Pharmacy (9.21)

Only a pharmacist shall have access to the pharmacy stock of controlled dangerous substances
in Schedules II through V.
In a pharmacist’s absence from an institution, a registered nurse designated by the PIC may
obtain medication from the hospital pharmacy as needed in an emergency and not available as
floor stock.
A designated registered nurse shall remove only those medication doses that shall be
administered prior to the opening of the pharmacy. The designated registered nurse may
remove the following from the pharmacy:
▪ A drug in its original container or a drug pre-packaged by the pharmacy
▪ Dose(s) of a drug from the original container for a specific patient
The pharmacist in charge shall obtain from the registered nurse on a suitable form a record of
any drugs removed showing the following: name of the drug; dosage size; amount taken; date;
patient’s name and location; and signature of the nurse as well as the container from which the
required dose(s) was taken in order that it may be properly checked.
All records involving drug s removed from the pharmacy shall be maintained or stored in original
hard copy form or in any other media that facilitates the reproduction of the original hard copy,
and shall be kept by the pharmacy for five years (may be kept off-site).
▪ The oldest four years of information shall be maintained in such a manner so as to be retrievable
and readable within two weeks.
▪ The most recent one year of information shall be retrievable and readable within one business day.

5.10.20 Storage and Security (9.23)

All drugs shall be secured for safe use and protected against illicit diversion. CDS in the institutional
pharmacy and throughout the facility shall be stored and protected in conformance with State and
Federal laws and regulations.
Supplies of external preparations stored in patient care areas shall be kept separate from internal
medications.
The PIC or, the director of pharmaceutical services shall be responsible for all the medications in
the facility, who shall establish a system of control for all drugs dispensed for use in the drug therapy
of patients of the facility.
5.10.20.1 Inspections

Inspections shall be conducted of all medication areas located in the facility or any other service
area of the facility at least once every two months to check for expiration or use by dates,
proper storage, misbranding, physical integrity, security and accountability of all drugs. These
inspections shall be fully documented. Written inspection reports shall be prepared and signed by
the inspecting pharmacist or by the pharmacy technician, intern or extern and co-signed by
his or her supervising pharmacist. The PIC shall be responsible for ensuring that, prior to
performing any inspections pursuant to this subsection, pharmacy technicians, interns and
externs are trained and can successfully demonstrate competency. Procedures for the review of
these reports shall be developed and instituted by the PIC.
The PIC shall develop procedures to assure the immediate and efficient removal of all outdated and
recalled drugs from patient care access areas and from the active stock of the pharmacy.

5.10.21 Institutional Decentralized Pharmacies (9.25)

Medications shall not be dispensed from a decentralized pharmacy without a pharmacist present,
except that, when the decentralized pharmacy is closed, a licensed nurse may dispense medication
in accordance with the written policies and procedures of the institution.
Institutions operating decentralized pharmacies shall notify the board, in writing, of the existence of,
and the discontinuance of, each decentralized pharmacy location.
Satellite pharmacies should be routinely included in the (every 2 months) inspections as explained in
9.23.

5.10.22 Valid medication orders; out of state medication orders

(9.26)
Only medication orders issued by a practitioner licensed to write medication orders in the United
States or any territory of the United States shall be considered valid medication orders and such
medication orders shall be filled pursuant to New Jersey law.

5.10.23 Prescriptions and Medication Orders Transmitted by

Technological Devices in an Institution (9.27)
A pharmacist may accept for dispensing a prescription or a medication order transmitted by fax or
other technological device as approved by the board. A pharmacist filling prescriptions under an
institutional permit for employees of the institution, their dependents, and for outpatients may
accept for dispensing faxed prescriptions for all substances consistent with the traditional rules for
retail pharmacies.
A pharmacist who is authorized to fill inpatient medication orders may accept all inpatient
medication orders, including orders for Schedule II substances, which have been transmitted by
technological device (fax).
No licensee or permit holder shall enter into any agreement with an authorized practitioner which
denies the patient the right to have his or her prescription transmitted by technological device to a
pharmacy of the patient's choice.
The mandatory requirements of this section shall be implemented in accordance with
the policy and protocols of the P&T Committee.
 The pharmacist shall participate in the drug education programs of the facility

“Satellite pharmacies’’ means areas within the health care institution that has been
issued an institutional permit other than the original institutional permitted location,
where the preparation, dispensing, and compounding of medications are performed.

No licensee or permit holder shall under any circumstances provide a technological

device to, or accept a technological device from, any practitioner licensed to write
prescriptions.

5.11 Automated Medication Systems

"Automated medication system" means any process that performs operations or activities, other than
compounding or administration, relative to the storage, packaging, dispensing and distribution of
medications, and which collects, controls and maintains all transaction information. "Automated
medication system" does not mean an automatic counting device such as an automatic pill
counter or a mechanical drug dispensing device such as a Pyxis device in a hospital.

5.11.1 Authority to Use Automated Medication System

(10.3)
5.11.1.1 Overall AMS Requirements

• The PIC shall be responsible for the supervision of the operation of the system, or in the case of an
automated medication system utilized at a location with no on-site pharmacy, the pharmacist-in-
charge of the provider pharmacy shall be responsible
• The Pharmacy has conducted a self inspection of the AMS on form provided by the board and
submitted to the Board
• The AMS has been tested by the pharmacy for accuracy and upon request, makes the results
available to the Board
• The AMS is made available to the Board for inspection, to validate accuracy of the self-inspection
and/or of the system
5.11.1.2 Responsibilities of the PIC

• Reviewing and approving all policies and procedures for system operation, safety, security,
accuracy, and access, patient confidentiality and prevention of unauthorized access and
malfunction;
• Ensuring that medications in the AMS system are inspected, at least once every 2 months for
expiration or “use by” date, misbranding and physical integrity, and for security and accountability
• Assigning, discontinuing or changing personnel access to the AMS
• Ensuring that the AMS is stocked accurately and accountability record is maintained in
accordance with the written policies and procedures of operation

5.11.2 Written Policies and Procedures of Operation (10.4)

When an AMS is used to fill prescriptions or medication orders, it shall be operated according to
written policies and procedures of operation that:
• Include a Table of Contents
• Include a description of all procedures of operation
• Ensure retention of each amendment, addition, deletion or other change to the policies and
procedures of operation for at least two years after the change is
made. Each such change shall be signed or initialed by the PIC and shall include the date on
which the pharmacist in charge approved the change
• Ensure that a pharmacist currently licensed in the transmitting jurisdiction reviews and approves
the transmission of each original or new prescription or medication order to the automated
medication system before transmission
• Set forth methods to identify the quality control measures in place to ensure the accuracy of the final
dispensed product
• Set forth methods that shall ensure that access to the records of medications and other medical
information of the patients maintained by the pharmacy is limited to licensed practitioners or
personnel approved to have access to the records
• Set forth methods that shall ensure that access to the AMS for stocking and retrieval of
medications is limited to licensed practitioners or qualified pharmacy technicians, interns and
externs acting under the supervision of a pharmacist.
o An accountability record which documents all transactions relative to stocking and removing
medications from the automated medication system shall be maintained
• Identify the circumstances under which medications may be removed from the AMS by a
licensed practitioner for distribution to a patient without prior order review by a pharmacist
• Provides for an annual review of the written policies and procedures of operation and revision if
necessary
A copy of the written policies and procedures of operation shall be retained at the pharmacy and at
the healthcare facility where the automated medication system is utilized. Upon request, the
pharmacy shall provide to the Board a copy of the written policies and procedures of operation for
inspection and review.

5.11.3 Personnel Training Requirements (10.5)

The PIC shall be responsible forensuring that, prior to performing any services in connection
with an AMS, all pharmacists and pharmacy technicians, interns, and externs are trained in the
pharmacy’s standard operating procedures with regard to AMS.

5.11.4 Written Program for Quality Assurance (10.6)

A pharmacy which uses an AMS shall operate according to a written program for quality
assurance which:
• Requires continuous monitoring of the AMS
• Establishes mechanisms and procedures to test the accuracy of the AMS at least every six
months and whenever any upgrade or change is made
• Establishes a protocol for measuring the effectiveness of the AMS
• Requires the pharmacy to report to the Board each recurring error of the automated medication
system
• Requires the pharmacy to maintain all documentation relating to the written program for quality
assurance for at least two years

5.11.5 Written Plan for Recovery (10.7)

A pharmacy using an AMS shall maintain a written plan for disaster recovery:
• Planning and preparation for a disaster
• Procedures for response to a disaster
• Procedures for the maintenance and testing of the written plan for recovery
• Procedure to notify the following parties of a disaster and the date on which the pharmacy
expects to recommence the provision of service:
o The Board
o Each organization which has contracted with the pharmacy
o Each patient of the pharmacy
o Other appropriate agencies

5.11.6 Written Program for Preventative Maintenance of

Automated Medication System (10.8)
A pharmacy that uses an AMS shall maintain a written program for preventative maintenance.

A “recurring error,’’ for purposes of this section, means any specific type
of inaccuracy within the automated medication system that occurs more
than twice within a 14 day period

5.12 Compounding Sterile Preparations in Retail

and Institutional Pharmacies
5.12.1 Purpose and scope (11.1)
The rules in this sub-chapter regulate the practice of sterile compounding and shall apply to all
retail and institutional pharmacies that compound and dispense sterile preparations.

5.12.2 Definitions (11.2)

"Ante area" means an ISO class 8 or better area where personnel hand hygiene and garbing
procedures, staging of components, order entry, labeling, and other high-particulate-generating
activities are performed. The "ante area" is also a transition area that
• Provides assurance that pressure relationships are constantly maintained so that air flows from
clean to dirty areas; and
• Reduces the need for the heating, ventilating, and air-conditioning (HVAC) control system to
respond to large disturbances.
"Biological safety cabinet" means a ventilated cabinet for compounded sterile preparations that
has an open front with inward airflow for personnel protection, downward high-efficiency
particulate air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhaust
air for environmental protection.
"Buffer area" means an ISO class 7 area where the primary engineering control is physically
located and where the preparation and staging of components and supplies used in compounding
sterile preparations occurs.
"Cleanroom" means a room in which the concentration of airborne particles is controlled to
meet a specified airborne particulate cleanliness (ISO) class. Microorganisms in the environment are
monitored, so that a microbial level for air, surface, and personnel gear are not exceeded for a
specified cleanliness class. A "cleanroom" includes a buffer area or room and an ante area or
room.
"Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or
device as the result of a practitioner's prescription or medication order or initiative based on the
relationship of the practitioner or the patient with the pharmacist 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 also includes the preparation of drugs or devices in anticipation of
prescriptions or medication orders based on routine, regularly-observed prescribing patterns.
Compounding includes mixing, reconstituting, or assembling a drug according to the product's
labeling or to the manufacturer's directions.
"Compounding aseptic containment isolator" means a compounding aseptic isolator designed to
provide worker protection from exposure to undesirable levels of airborne hazardous drugs
throughout the compounding and material transfer processes and to provide an aseptic environment
for compounding sterile preparations. Air exchange with the surrounding environment should not
occur unless the air is first passed through a microbial retentive filter (high-efficiency particulate air
(HEPA) minimum) system capable of containing airborne concentrations of the physical size and
state of the drug being compounded.
"Compounding aseptic isolator" means a form of isolator specifically designed for compounding
pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding
environment within the isolator throughout the compounding and material transfer process. Air
exchanges into the isolator from the surrounding environment should not occur unless the air has
first passed through a microbially retentive filter (high-efficiency particulate air (HEPA) minimum).
"Immediate use compounded sterile preparations" means preparations intended for emergency
patient care and involve only simple aseptic measuring and transfer manipulations of no more than
three sterile non-hazardous commercial drug and diagnostic radiopharmaceutical drug products,
including an infusion or diluent solution. Unless required for the preparation, the compounding
process occurs continuously without delays or interruptions and does not exceed one hour.
Administration of immediate use compounded sterile preparations shall begin within one hour of
preparation or the compounded sterile preparations shall be discarded. Immediate use compounded
sterile preparations shall not be compounded and stored for anticipated needs and shall not be
compounded as batch preparations. At no time during the compounding process, nor prior to
administration, are critical sites and ingredients of the compounded sterile preparation directly
exposed to contact contamination, such as human touch, cosmetic flakes, or particulates, blood,
human body substances, and non-sterile inanimate sources.
 "ISO class 5 air quality conditions" means conditions in which the air particle count is no greater
than a total of 3,520 particles of 0.5 micrometers and larger per cubic meter of air (100
particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered
air.
"ISO class 7 air quality conditions" means conditions in which the air particle count is no greater
than a total of 352,000 particles of 0.5 micrometers and larger per cubic meter of air (10,000
particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered
air.
"ISO class 8 air quality conditions" means conditions in which the air particle count is no greater
than a total of 3,520,000 particles of 0.5 micrometers and larger per cubic meter of air
(100,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or
HEPA-filtered air.
"Negative pressure room" means a room that is at a lower pressure than the adjacent spaces and,
therefore, the net airflow is into the room.
“Positive pressure room" means a room that is at a higher pressure than the adjacent spaces and,
therefore, the net airflow is out of the room.
"Primary engineering control" means a device or room that provides an ISO class 5
environment for the exposure of critical sites when compounding sterile preparations. Such devices
include;
• Laminar airflow workbenches
• Biological safety cabinets
• Compounding aseptic isolators
• Compounding aseptic containment isolators
"Risk levels for compounded sterile preparations" means the established classification for
compounded sterile preparations based on the potential for microbial, chemical, and physical
contamination of the preparations and are defined as follows:
• "Low-risk level compounded sterile preparations" means preparations compounded with aseptic
manipulations entirely within ISO class 5 or better air quality using only sterile ingredients, products,
components, and devices. The compounding process involves only assembling, transferring,
measuring, and mixing, using no more than three commercially manufactured sterile products, and
not more than two entries into one sterile container or package to make the compounded sterile
preparations. The compounding process is limited to aseptically opening ampules, penetrating sterile
stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes
to sterile administration devices, package containers of other sterile products, and containers for
storage and dispensing.
• "Medium-risk level compounded sterile preparations" means preparations compounded under low-
risk level conditions but which require multiple individual or small doses of sterile products to be
combined or pooled to prepare compounded sterile preparations that will be administered either to
multiple patients or to one patient on multiple occasions. The compounding process includes
complex aseptic manipulations other than single volume transfer, and requires an unusually long
duration, such as that required to complete dissolution or homogeneous mixing.
• "High-risk level compounded sterile preparations" means preparations compounded from non-sterile
ingredients or from ingredients that are incorporated using non-sterile equipment before terminal
sterilization, or from commercially manufactured sterile products that lack effective antimicrobial
preservatives and whose preparation, transfer, sterilization, and packaging is performed in air quality
worse than ISO class 5 for more than one hour. Water-containing preparations that are stored for
 more than six hours before terminal sterilization are also classified as high-risk level compounded
sterile preparations.

5.12.3 Application and pre-approval requirements for

compounding sterile preparations (11.3)
5.12.3.1 New Applications

An applicant for a new pharmacy or an existing pharmacy that wishes to compound sterile
preparations shall:
• Submit plans detailing the physical arrangements necessary to ensure compliance with the sterile
compounding requirements.
• Not dispense sterile compounded preparations until receiving written approval from the Board to
engage in such activities. Prior to issuing the written approval, the Board shall conduct an inspection
of the pharmacy to ensure compliance.
5.12.3.2 Operational Changes for Previously Approved Sterile Compounders

A pharmacy permit holder who is approved to compound sterile preparations shall notify the Board
at least 60 days in advance of any remodeling, change of location, or change in size of the
pharmacy cleanroom. Such notification shall include the pharmacy's remodeling or relocation
plans, as appropriate, the pharmacy's interim plans for the continuation of sterile compounding
operations, which the Board shall review and approve, and the anticipated date of completion. The
pharmacy permit holder and the pharmacist-in-charge shall ensure compliance with all requirements
while compounding operations continue during the remodeling or relocation process. The pharmacy
permit holder shall notify the Board upon completion of the remodeling or relocation process, at
which time the Board shall inspect the premises.
A pharmacy holding an institutional permit that is approved to compound sterile preparations and
that intends to compound sterile preparations using a laminar airflow workbench not located in a
buffer area, shall notify the Board at least 60 days in advance of its intention and of all
locations where such equipment will be installed. The pharmacy permit holder shall notify the Board
upon completion of such installation, at which time the Board shall inspect the equipment. The
pharmacy shall not utilize such equipment to compound sterile preparations until receiving Board
approval.
A pharmacy permit holder who is approved to compound sterile preparations and who intends to
utilize compounding aseptic isolators or compounding aseptic containment isolators not
located in a buffer area shall notify the Board at least 60 days in advance of its intention and
of all locations where such equipment will be installed. The pharmacy permit holder shall notify the
Board upon completion of such installation, at which time the Board shall inspect the equipment.
The pharmacy shall not utilize such equipment to compound sterile preparations until receiving
Board approval.

5.12.4 Cleanroom: use, access, location; temperature; air

pressure (11.4)
The pharmacy shall have a designated area for sterile preparation compounding, known as
the "cleanroom." A cleanroom shall be physically designed and environmentally controlled to
minimize airborne contamination from contacting critical sites. Critical sites are locations that include
any component or fluid pathway surfaces (for example, vial septa, injection ports, beakers),
openings (for example, opened ampules, needle hubs), exposed and at risk of direct contact with air
 (for example, ambient room or HEPA-filtered), moisture (for example, oral and mucosal secretions),
or touch contamination.
A cleanroom shall include a buffer area and an ante area. The buffer area shall contain an ISO
class 5 or better primary engineering control, such as a laminar airflow workbench, biological safety
cabinet, compounding aseptic isolator, and/or compounding aseptic containment isolator, unless the
buffer area has ISO class 5 or better air quality.
All sterile compounding shall take place within the confines of the buffer area, except for the
following:
• Compounding in a compounding aseptic isolator or a compounding aseptic containment isolator
• Compounding in a laminar airflow workbench in an institutional pharmacy
• Compounding immediate use compounded sterile preparations in an institutional pharmacy
A cleanroom shall be:
• Accessible only to designated personnel
• Used only for the compounding of sterile preparations or such other tasks that require a cleanroom
• Structurally isolated from other areas within the pharmacy by means of restricted entry or access
• Air conditioned to maintain a temperature of 59 to 77 degrees Fahrenheit with an ideal
temperature of 66 degrees Fahrenheit
5.12.4.1 Air Pressure

A pressure indicator or air velocity meter shall be installed that can be readily monitored for
correct room pressurization or air velocity:
• For compounding of non-hazardous drugs, if the buffer area and the ante area are physically
separated through the use of walls, doors, and pass-throughs, a minimum differential positive
pressure of 0.02 inch to 0.05 inch water column shall be required. For buffer areas not physically
separated from the ante area, an air velocity of 40 feet per minute or more from the buffer area
across the line of demarcation into the ante area is required.
• For compounding of antineoplastic agents and other hazardous substances in a cleanroom, the
primary engineering control shall be placed in an ISO class 7 buffer room that is physically
separated from other preparation areas and has not less than 0.01 inch water column negative
pressure to adjacent positive pressure ISO class 7 or better ante room, thus providing inward airflow
to contain any airborne drug.
• For compounding of antineoplastic agents and other hazardous substances outside of a cleanroom,
if a compounding aseptic containment isolator is used outside of a buffer area, the compounding
area shall be physically separated from other areas and shall maintain a minimum negative pressure
of 0.01 inch water column and have a minimum of 12 air exchanges per hour.
No chewing gum, drinks, candy, or food items shall be brought into the cleanroom.

5.12.5 Cleanroom requirements (11.5)

The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the cleanroom
shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby minimizing
spaces in which microorganisms and other contaminants may accumulate.
 Work surfaces shall be constructed of smooth, impervious materials, such as stainless steel or
molded plastic, so that the work surfaces may be readily cleaned and sanitized. All work surfaces
shall be resistant to damage from cleaning and sanitizing agents.
Junctures where ceilings meet walls shall be covered, caulked, or sealed to avoid cracks and
crevices in which microorganisms and other contaminates can accumulate. All areas in ceilings and
walls where the surface has been penetrated shall be sealed.
Ceilings that consist of inlaid panels shall be impregnated with a polymer to render them impervious
and hydrophobic and shall either be caulked or weighted and clipped.
Walls shall be constructed of flexible material (for example, heavy gauge polymer), panels locked
together and sealed, or of epoxy-coated gypsum board.
Floors shall have a covering that shall be seamless or have heat-welded seams and coving to the
sidewall. There shall be no floor drains.
There shall be no dust-collection overhangs (such as ceiling utility pipes) and ledges (such as
window sills) should be avoided. All sprinkler heads shall be flush with the ceiling.
Ceiling lighting fixtures shall have exterior lens surfaces which are smooth, mounted flush, and air
tight.
Carts shall be of stainless steel wire, nonporous plastic, or sheet metal construction with good
quality, cleanable casters to promote mobility.
Refrigerators shall be within, or reasonably accessible to, the cleanroom in order to ensure the
integrity of the compounded sterile preparations.

5.12.6 Ante area requirements (11.6)

The ante area shall have appropriate environmental control devices capable of maintaining ISO
class 8 air quality conditions for non-hazardous drug compounding activities and ISO class 7 air
quality conditions for hazardous drug compounding activities.
The ante area shall contain the following equipment:
• A sink with hot and cold running water with an integrated and closed plumbing system
• Waste containers for all personal protective equipment
• An eyewash station
• A hazardous waste spill kit

5.12.7 Buffer area requirements (11.7)

The buffer area shall have appropriate environmental control devices capable of maintaining ISO
class 7 air quality conditions.
The buffer area shall contain only the following:
• Items such as furniture, equipment, supplies, and other materials that are required for the tasks to be
performed there
• Items that are nonpermeable, nonshedding, cleanable, and resistant to disinfectants
• Items that have been cleaned and disinfected immediately prior to their being placed in the buffer
area
Equipment and other items used in the buffer area shall not be taken from these areas except for
calibration, servicing, or other activities associated with the proper maintenance of the item.
The buffer area shall be kept clean and arranged in an orderly fashion. All required equipment shall
be maintained in good operating condition.
The buffer area shall not be used for bulk storage, warehousing, or clerical and secretarial functions.
The buffer area shall not contain any sinks.
The buffer area shall be a minimum of 100 square feet in size and shall be compatible with the
volume of compounding being conducted.
The buffer area shall contain waste containers in compliance with Occupational Safety and Health
Administration (OSHA) standards for disposal of used needles and syringes set forth in 29 CFR
1910.1030 and for disposal of chemotherapy waste set forth at 29 CFR 1910.1200, incorporated
herein by reference, and available at www.osha.gov.

5.12.8 Use of compounding aseptic isolators and

compounding aseptic containment isolators located
outside of a cleanroom (11.8)
A pharmacy may utilize compounding aseptic isolators and compounding aseptic containment
isolators not located in a cleanroom to prepare compounded sterile preparations, provided the
compounding aseptic isolators and compounding aseptic containment isolators can provide isolation
from the room and maintain ISO class 5 air quality during dynamic operating
conditions, including transferring ingredients, components, and devices into and out of the isolator
and during preparation of compounded sterile preparations.
A pharmacy utilizing a compounding aseptic containment isolator not located in a cleanroom to
compound antineoplastic agents and other hazardous substances the compounding area shall be
physically separated from other areas and shall maintain a minimum negative pressure of 0.01 inch
water column and have a minimum of 12 air exchanges per hour. Particle counts sampled
approximately six to 12 inches upstream of the critical exposure site must maintain ISO class 5 air
quality levels during compounding operations. Compounding personnel shall obtain documentation
from the manufacturer that the compounding aseptic isolator or compounding aseptic containment
isolator will meet this standard when located in worse than ISO class 7 environments. A
compounding aseptic isolator and compounding aseptic containment isolator not located in a buffer
area shall be located in an area that is maintained under sanitary conditions and such area shall only
be traveled by persons engaging in the compounding of sterile preparations.

5.12.9 Compounding of antineoplastic agents and other

hazardous substances (11.9)
For purposes of this section, hazardous substances are those substances identified as hazardous by
the National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication No. 2004-
165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health
Care Settings, Appendix A (2012 Edition). The sample list of drugs that shall be handled as
hazardous (Appendix A) is incorporated herein by reference, as amended and supplemented, and
can be found at the Centers for Disease Control and Prevention website, www.cdc.gov,
specifically, www.cdc.gov/niosh/docs/2004-165/.
Pharmacies shall not prepare antineoplastic agents and other hazardous substances as immediate
use compounded sterile preparations.
 Pharmacies shall compound antineoplastic agents and other hazardous substances only in:
• A compounding aseptic containment isolator or a Class II or Class III biological safety cabinet in a
negative pressure cleanroom. When handling volatile hazardous drugs, such devices shall be
vented to the outside air; or
• A compounding aseptic containment isolator located outside of a negative pressure cleanroom.
When handling volatile hazardous drugs, such devices shall be vented to the outside air.
Correct room pressurization shall be maintained at all times when compounding antineoplastic
agents and other hazardous substances.
Personnel who compound and dispense antineoplastic agents and other hazardous substances
shall adhere to standards established by the Occupational Health and Safety Administration (OSHA)
set forth in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure
to Hazardous Drugs (effective date January 20, 1999). OSHA's Technical Manual is incorporated
herein by reference, as amended and supplemented, and can be found at the OSHA
website, www.osha.gov, specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel
shall also comply with the standards established by NIOSH in NIOSH Publication No. 2004-165:
Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care
Settings. The NIOSH Publication No. 2004-165 (2012 Edition) is incorporated herein by reference,
as amended and supplemented, and can be found at the CDC website, www.cdc.gov,
specifically, www.cdc.gov/niosh/docs/2004-165/.
Antineoplastic agents and other hazardous substances used to compound sterile preparations shall
be stored separately from other inventory in a manner to prevent contamination and personnel
exposure. Such storage is preferable within a containment area such as a negative pressure room.
The storage area shall have sufficient general exhaust, at least 12 air exchanges per hour to dilute
and remove any airborne contaminants. Antineoplastic agents and hazardous substances used to
compound sterile preparations shall be handled with caution using appropriate chemotherapy gloves
during distribution, receiving, stocking, inventorying, preparing for administration, and disposal.

5.12.10 Institutional pharmacy use of airflow

workbenches not in a buffer area for low-risk level
compounded sterile preparations (11.10)
A pharmacy holding an institutional pharmacy permit may utilize ISO class 5 laminar airflow
workbenches not located in a buffer area to prepare low-risk level compounded sterile
preparations provided that the administration of such preparations commences within 12
hours of the preparation or as recommended by the manufacturer, whichever is less. Such
workbenches shall be located in an area which is maintained under sanitary conditions and which is
traveled only by persons engaging in the compounding of sterile preparations. Such workbenches
shall not be in a location that has unsealed windows or doors that connect to the outdoors or high
traffic flow, or that is adjacent to areas including, but not limited to, construction sites, warehouses,
or food preparation. Sinks may not be located adjacent to the ISO class 5 workbench environments
and must be separated from the immediate area of ISO class 5 workbenches. Personnel engaged in
sterile compounding in such areas shall follow the procedures relating to cleansing and garbing.

5.12.11 Compounding immediate use compounded sterile

preparations in an institutional pharmacy (11.11)
A pharmacy holding an institutional pharmacy permit may prepare non-hazardous immediate use
compounded sterile preparations outside of an ISO class 5 laminar airflow workbench when
 the delay resulting from the use of the workbench would harm the patient, including situations
in which the patient experiences a sudden change in clinical status.

5.12.12 Pharmacist-in-charge responsibilities (11.12)

The pharmacist-in-charge shall supervise all sterile compounding performed by pharmacy
personnel. The pharmacist-in-charge shall be trained in aseptic manipulation skills, and shall be
responsible for:
• Determining the procedural, environmental, and quality control practices that are necessary for the
risk levels he or she assigns to specific compounded sterile preparations
• Ensuring that the selected sterilization method both sterilizes and maintains the strength, purity,
quality, and packaging integrity of the compounded sterile preparations
• Ensuring the placement in buffer areas and ante areas of equipment (for example, refrigerators),
devices (for example, computers and printers) and objects (for example, carts and cabinets) that are
not essential to compounding is dictated by their effect on the required environmental quality of air
atmospheres and surfaces, which shall be verified by monitoring
• Storage of all materials pertinent to the compounding of sterile preparations, including drugs,
chemicals, and biologicals, and the establishment of specific procedures for procurement of the
materials in accordance with State and Federal laws and regulations
• Ensuring that all packaging and labeling of all compounded sterile preparations in the pharmacy are
performed under the immediate personal supervision of a pharmacist
• Ensuring that preparation and compounding of sterile preparations is performed only by pharmacists
who have been trained in aseptic manipulation skills, or by pharmacy technicians, pharmacy interns,
or pharmacy externs who have been trained in aseptic manipulation skills working under the
immediate personal supervision of a pharmacist trained in aseptic manipulation skills
• Recording all transactions of the pharmacy as may be necessary under applicable State, Federal,
and local laws and rules, to maintain accurate control over, and accountability for, all pharmaceutical
materials, and ensuring that policies and procedures exist with respect to the maintenance of the
audit trail
• Ensuring that all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs who
compound sterile preparations are trained and evaluated
• Establishing procedures for maintaining the integrity of the product and the manufacturer's control
identity when repackaging sterile products. A pharmacist shall check all repackaging and shall initial
the repackaging records.
• Disposal of all unused drugs and materials used in compounding sterile preparations, including
antineoplastic agents and other hazardous substances, in accordance with accepted professional
standards, and the Medical Waste Act, N.J.S.A. 13:1E-48.1 et seq., so as not to endanger the public
health
• Ensuring that the compounding area and its contents and other areas where compounded sterile
preparations are present are secured, so as to prevent access by unauthorized personnel
• Ensuring that the pharmacy contains, in addition to the minimum reference library, references
pertinent to compounding sterile preparations
• Ensuring that records are maintained that document, at least once daily, that appropriate controlled
cold (refrigerator), controlled freezer, if applicable, and controlled room temperatures, as these terms
 are defined in United States Pharmacopeia 797, are maintained. Such records shall be maintained
for no less than five years and shall be made available to the Board for inspection upon request
• Ensuring that all information required to be maintained as part of a pharmacy's patient profile record
system is maintained for all compounded sterile preparations
• Ensuring that initial and ongoing multidisciplinary clinical monitoring and comprehensive care plans
are maintained and readily available
• Maintaining a policy and procedures manual detailing the pharmacy's standard operating procedures
with regard to compounded sterile preparations, and maintaining a written quality assurance
program.

5.12.13 Pharmacy technicians, pharmacy interns, and

pharmacy externs; required supervision (11.13)
Pharmacists shall provide immediate personal supervision to pharmacy technicians, pharmacy
interns, or pharmacy externs who are performing sterile compounding. The ratio of pharmacists to
pharmacy technicians shall not exceed 1:2 at any given time unless all of the requirements of
N.J.A.C. 13:39-6.15 are met.
Supervision shall include, but is not limited to, the checking of each ingredient used, the quantity of
each ingredient whether weighed, measured or counted, and the finished label.
The pharmacist may delegate to pharmacy technicians, pharmacy interns, or pharmacy externs only
the following tasks: recording of the prescription, selection of the drugs, container, and diluent,
labeling, and compounding of preparations. The pharmacist shall ensure that each task has been
performed correctly.

5.12.14 Personnel cleansing and garbing requirements

(11.14)
All personnel who engage in compounding sterile preparations shall comply with the following
requirements before entering the buffer area:
• Personnel shall remove personal outer garments (for example, bandanas, coats, hats, jackets,
scarves, sweaters, vests), all cosmetics, and hand, wrist, and other visible jewelry or piercings (for
example, earrings, or lip or eyebrow piercings)
• The wearing of artificial nails or extenders is prohibited while working in the compounding area.
Natural nails shall be kept neat and trimmed
• Personnel protective equipment shall be donned in the following order:
• Dedicated shoes or shoe covers
• Head and facial hair covers (for example, beard covers in addition to face masks)
• Face masks
• Eye shields, if required
A hand and forearm cleansing procedure shall be performed. Personnel shall remove debris from
underneath fingernails using a nail cleaner under running warm water followed by vigorous hand
washing for at least 30 seconds. Hands and forearms to the elbows shall be completely dried using
either lint-free disposable towels or an electric hand dryer; and
 Personnel shall wear non-shedding gowns with sleeves that fit snugly around the wrists and
enclosed at the neck, that are designed for buffer area use.
Once inside the buffer area, personnel shall perform antiseptic hand cleansing, using a water-less
alcohol-based surgical hand scrub with persistent activity following manufacturers'
recommendations. Once hands are dried thoroughly, personnel shall don sterile gloves. Gloves shall
be routinely inspected for holes, punctures, or tears, and shall be replaced immediately if any are
detected.
• Gloves become contaminated when they make contact with non-sterile surfaces during
compounding activities. Disinfection of contaminated gloved hands may be accomplished by wiping
or rubbing sterile 70 percent Isopropyl Alcohol (IPA) on all contact surface areas of the gloves and
letting the gloved hands dry thoroughly. Routine application of sterile 70 percent IPA shall occur
throughout the compounding process and whenever non-sterile surfaces (for example, vials, counter
tops, chairs, and carts) are touched.
When compounding personnel exit the cleanroom during a work shift, the exterior gown may be
removed and retained in the cleanroom if not visibly soiled, and may be re-donned during that same
work shift only. Shoe covers, hair and facial hair covers, face masks/eye shields, and gloves,
however, shall be replaced with new ones before re-entering the buffer area, and proper hand
hygiene shall be performed, as described above.

5.12.15 Cleaning and disinfection requirements for

cleanroom, buffer area, and ante area (11.15)
The cleanroom, buffer area, and ante area shall be cleaned and disinfected consistent with the
following requirements:
• All surfaces in laminar airflow workbenches, biological safety cabinets, compounding aseptic
isolators, and compounding aseptic containment isolators shall be cleaned and disinfected at the
beginning of each work shift, before each batch preparation is started, after spills, and when surface
contamination is known or suspected
• All counters, work surfaces, and floors shall be cleaned and disinfected daily
• All walls, ceilings, and storage shelving shall be cleaned monthly
All cleaning and disinfection shall be performed consistent with the standards established in USP
797 Appendix II, which is incorporated herein by reference, as amended and supplemented, and
which is available for purchase at the United States Pharmacopeia website, www.usp.org.

5.12.16 Training and evaluation requirements (11.16)

The pharmacist-in-charge and all pharmacists, pharmacy technicians, pharmacy interns, and
pharmacy externs involved in compounding sterile preparations shall have didactic and
practical training in sterile preparation compounding, including proper personnel cleansing and
garbing, and cleaning and disinfecting the sterile compounding areas, cleanroom technology,
laminar flow technology, isolator technology, if applicable, and quality assurance techniques. Such
training shall be documented for each person before that individual begins to compound sterile
preparations and annually thereafter for all pharmacists, pharmacy technicians, pharmacy interns,
and pharmacy externs who compound sterile preparations. That documentation shall be
maintained by the permit holder for five years and made available to the Board upon request.
The pharmacist-in-charge shall be responsible for ensuring that, prior to compounding sterile
preparations and annually thereafter, all pharmacists, pharmacy technicians, pharmacy interns,
and pharmacy externs shall have passed a written test that demonstrates competency in all
 areas above, and in the pharmacy's standard operating procedures with regard to compounding
sterile preparations as set forth in the policy and procedure manual.
The pharmacist-in-charge shall be responsible for testing of the aseptic technique of all
pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in
compounding sterile preparations, consistent with the methods set forth in USP 797 concerning
"Aseptic Manipulation Competency Evaluation," incorporated herein by reference, as amended and
supplemented, and which is available for purchase at the United States Pharmacopeia
website, www.usp.org, prior to compounding sterile preparations. Aseptic technique re-testing shall
be conducted annually for all personnel engaged in compounding low- and medium-risk level
preparations and semi-annually for all personnel engaged in compounding high-risk level
preparations.
All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs engaging in
the compounding of sterile preparations shall successfully complete an initial gloved
fingertip/thumb sampling procedure prior to compounding sterile preparations. Gloved
fingertip/thumb sampling shall be conducted annually for all personnel engaged in
compounding low- and medium-risk level preparations and semi-annually for all personnel
engaged in compounding high-risk level preparations.
Individuals who fail the written test and/or the test of aseptic technique shall be prohibited from
compounding sterile preparations until passing both tests. All test results shall be maintained by the
permit holder for five years and shall be made available to the Board for inspection upon request.

5.12.17 Batch preparation (11.17)

Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs, may compound
sterile preparations in a quantity that is supported by prior valid prescriptions or medication orders
before receiving a valid written prescription or medication order, provided the pharmacist:
• Documents a history of valid prescriptions or medication orders subsequently received, within the
beyond-use dating time of each product, which have been generated solely within an established
professional prescriber-patient-pharmacist relationship
• Mantains the prescription or medication order on file for all such products dispensed at the pharmacy
• Documents the batch preparation process, including selection of the drugs, containers, and diluents,
lot numbers and expiration dates of the drugs, containers, and diluents, if any, and verification that
the compounded sterile preparation has been visually inspected to ensure the absence of particulate
matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness
of labeling. Each batch shall be given a unique batch number to identify the specific
batch; and
• Ensures that the labeling requirements are satisfied.
Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs may batch prepare
compounded sterile preparations for use by a licensed prescriber in his or her practice without a
prescription, provided the pharmacist:
• Complies with all state and federal laws pertinent to the prescriber's health care practice
• Documents the batch preparation process in accordance with N.J.A.C. 13:39-11.20(c).
 5.12.18 Compounded sterile preparations for prescriber
practice use (11.18)
A pharmacy may prepare compounded sterile preparations for a licensed prescriber for use in the
prescriber's practice without a prescription consistent with State and Federal laws pertinent to the
prescriber's health care practice.

5.12.19 Stability criteria and beyond-use dating (11.19)

For purposes of this section, stability means the extent to which a preparation retains, within
specified limits and throughout its period of storage and use, the same properties and characteristics
that it possessed at the time of compounding.
In the absence of supporting valid scientific sterility testing and stability information that is directly
applicable to specific preparations, the following dates and times for storage and initiation of
administration of the compounded sterile preparations shall apply, according to the assigned risk
level of the preparation, unless the manufacturer's package indicates a different stability time:
• For low-risk level compounded sterile preparations, in the absence of passing a sterility test:
o Administration shall begin within 48 hours when the preparation is stored at controlled room
temperature (20 degrees Celsius to 25 degrees Celsius);
o Administration shall begin within 14 days when the preparation is stored at cold temperatures (two
degrees Celsius to eight degrees Celsius);
o Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20
degrees Celsius); and
o For products prepared in an airflow workbench not located in a buffer area in accordance with
N.J.A.C. 13:39-11.10, administration shall begin within 12 hours or less of preparation;
• For medium-risk level compounded sterile preparations, in the absence of passing a sterility
test:
o Administration shall begin within 30 hours when the preparation is stored at controlled room
temperature (20 degrees Celsius to 25 degrees Celsius);
o Administration shall begin within nine days when the preparation is stored at cold temperatures (two
degrees Celsius to eight degrees Celsius); and
o Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20
degrees Celsius);
• For high-risk level compounded sterile preparations, in the absence of passing a sterility test:
o Administration shall begin within 24 hours when the preparation is stored at controlled room
temperature (20 degrees Celsius to 25 degrees Celsius);
o Administration shall begin within three days when the preparation is stored at cold temperatures (two
degrees Celsius to eight degrees Celsius); and
o Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20
degrees Celsius); and
• For immediate use compounded sterile preparations, administration shall begin no less than
one hour following the start of preparing the compounded sterile preparation.
 The administration dates and times established above shall not be exceeded or extended for
compounded sterile preparations without verifiable supporting valid scientific sterility and stability
information that is directly applicable to the specific preparation or compound.
A pharmacist shall determine the beyond-use date for a compounded sterile preparation consistent
with above and assign an appropriate discard-after date for the compounded sterile preparation. The
discard-after date shall appear on the label.
5.12.19.1 Miscellaneous beyond use dating requirements

Opened or needle-punctured single-dose containers of sterile products (for example, bags,

bottles, syringes, and vials) used in the compounding of sterile preparations for immediate use in
an institutional pharmacy pursuant to N.J.A.C. 13:39-11.11, shall be used within one hour if
opened in worse than ISO Class 5 air quality, and any remaining contents shall be discarded.
Single-dose vials used in the compounding of sterile preparations exposed to ISO Class 5 or
cleaner air quality may be used up to six hours after initial puncture.
Opened single-dose ampules used in the compounding of sterile preparations shall not be
stored for any period of time.
Opened or needle-punctured multiple-dose vials used in the compounding of sterile
preparations shall be used within 28 days after initially entering the vial, unless otherwise
specified by the manufacturer.

5.12.20 Documentation; audit trail (11.20)

The pharmacist shall ensure that compounded sterile preparations have been properly prepared,
consistent with the assigned risk level of the preparation, labeled, controlled, stored, dispensed, and
distributed in accordance with this overall section. The pharmacist shall be responsible for the
accuracy and appropriateness of the compounded prescription. When more than one pharmacist is
involved in the steps of the compounding process, the pharmacist shall be responsible for the
accuracy and appropriateness of each step he or she performed or he or she approved and
reviewed, and his or her unique and secure user identifier(s) shall be recorded in the audit trail.
A pharmacy shall maintain an audit trail for all compounded sterile preparations.
A pharmacy shall maintain a compounding record for each compounded sterile preparation that
contains the following information:
• Selection of the drugs, container, and diluent prior to their being compounded, including
documentation of lot numbers and expiration dates of the drugs, containers, and diluents, if
applicable
• Verification that ingredients comply with the prescription or medication order
• Verification that the prescription or medication order label complies with the applicable label
requirements described below
• Verification that the compounded sterile preparation has been visually inspected to ensure the
absence of particulate matter in solutions, the absence of leakage from vials and bags, and the
accuracy and thoroughness of labeling
• Verification that the prescription or medication order is complete and ready to be dispensed,
including any necessary ancillary supplies
 5.12.21 Information required to appear on prescription
label (11.21)
The dispensed container for any compounded sterile preparation shall bear a permanently affixed
label with at least the following information:
• The date and time prepared
• In the retail pharmacy only, the name of the prescriber
• The name of the patient
• Directions for use
• The name and strength or quantity of all active ingredients, and the name and volume of the diluent,
vehicle, and base solution(s), if applicable
• The name, address, and telephone number of the pharmacy
• The phrase "use by" followed by the preparation's use by date and time (if no time is stated, it is
presumed to be 11:59 P.M. of the stated use by date)
• Any ancillary and cautionary instructions as needed
• As pertinent, a warning, consistent with applicable Federal and State law, that antineoplastic agents
and other hazardous substances are biohazardous
• As pertinent, the requirements for proper storage
• In a retail pharmacy, for those medications not dispensed in a health care facility, the prescription
number.
For immediate use compounded sterile preparations, when the preparation is not administered by
the person who prepared it, or its administration is not witnessed by the person who prepared it, the
compounded sterile preparation shall be labeled consistent with the requirements above and shall
also include the name or identifier of the person who prepared the compounded sterile preparation.

5.12.22 Handling, packaging, and delivery (11.22)

The pharmacy shall be responsible for the proper handling and packaging of compounded sterile
preparations for delivery from the pharmacy to the patient in order to assure and maintain the
integrity, efficacy, stability, and sterility of these preparations. The pharmacist-in-charge shall ensure
that:
• Tamper-evident packaging is utilized
• Delivery is made from the pharmacy to the patient or patient care location within a reasonable time
• Proper in-transit storage is provided consistent with product labeling

5.12.23 Policy and procedures manual (11.23)

The pharmacy's policy and procedures manual shall set forth in detail the pharmacy's standard
operating procedures with regard to compounded sterile preparations, including:
• A risk-management program, including, but not limited to, documentation of incidents, adverse
drug reactions, and product contamination
• The risk-management program shall require that the pharmacist-in-charge report all confirmed
incidents of product contamination to the New Jersey Board of Pharmacy within 48 hours of
becoming aware of such incidents
• Security measures ensuring that the premises where compounded sterile drugs are present are
secured, so as to prevent access by unauthorized personnel
• Equipment
• Procedures for use
• Documentation of appropriate certifications
• Cleaning and disinfecting standards and procedures
• Reference materials
• Information concerning drug
o Preparation
o Storage and handling
o Dispensing
o Delivery
o Destruction, recalls and returns
• Patient profile recordkeeping
• Handling, dispensing and documentation of investigational new drugs;
• A quality assurance program
• Verification of training and competency guidelines as set fo
• Compounding process validation;
• Audit trail documentation
• Description of appropriate garb and garbing procedures
• Conduct guidelines for personnel in the cleanroom
• Personnel responsibilities
• Patient education
• Protocol and procedures to maintain the integrity of the interior work area of the laminar airflow
workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and
biological safety cabinets
• Written procedures in compliance with the Occupational Safety and Health Administration standards
for handling small and large spills of antineoplastic agents and other hazardous substances.
The policy and procedures manual shall be reviewed, at a minimum, once every 24
months and shall be updated, on a continuous basis, to reflect current practice. Documentation of
the review shall be made available to the Board upon request.

5.12.24 Quality assurance program (11.24)

The pharmacy's quality assurance program shall require, at a minimum, that:
• A reasonable effort shall be made by the pharmacist to assure that compounded sterile preparations
shall be kept under appropriate controlled conditions at the location of use by providing adequate
labeling and verbal or written instructions regarding proper storage and administration as set forth by
the product manufacturer, with each compounded sterile preparation dispensed
• The quality assurance program encompasses all phases of sterile compounding for each unique
type of compounded sterile preparation dispensed
• After the preparation of every admixture, the contents of the container are thoroughly mixed and
then visually inspected to ensure the absence of particulate matter in solutions, the absence of
leakage from vials and bags, or any other defects, and the accuracy and thoroughness of labeling
• All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in
compounding sterile preparations shall have their aseptic technique according to requirements
• The following shall be tested to ensure that they are sterile before they are dispensed or
administered.
o All high-risk level compounded sterile preparations that are prepared in groups of more than 25
identical individual single-dose packages (for example, ampules, bags, syringes, vials)
o All high-risk level compounded sterile preparations in multiple-dose vials for administration to
multiple patients
o All high-risk level compounded sterile preparations that are exposed longer than 12 hours at two
degrees to eight degrees Celsius and longer than six hours at warmer than eight degrees Celsius
before they are sterilized,
o All compounded sterile preparations whose beyond-use date has been exceeded
The USP membrane filtration method shall be used where feasible. Another method may be used if
verification results demonstrate that the alternative is at least as effective and reliable as the
membrane filtration method or the USP direct inoculation of the culture medium method, consistent
with the standards set forth in USP 797 concerning "Sterility Testing," 2012 edition, incorporated
herein by reference, as amended and supplemented, and available for purchase at the United States
Pharmacopeia website, www.usp.org.
• When high-risk level compounded sterile preparations are dispensed before receiving the results of
the sterility tests set forth above, the written quality assurance procedure shall require daily
observation of the incubating test specimens and immediate recall of the dispensed compounded
sterile preparations when there is any evidence of microbial growth in the test specimens. The
patient and the physician of the patient to whom a potentially contaminated compounded sterile
preparation was administered shall be notified immediately of the potential risk. Positive sterility tests
shall require rapid and systematic investigation of aseptic technique, environmental control, and
other sterility assurance controls in order to identify sources of contamination and to take corrective
action.
• All high-risk level compounded sterile preparations, except those for inhalation and ophthalmic
administration, shall be tested to ensure that they do not contain excessive bacterial endotoxins;
• Air and surface sampling for microbial organisms in ISO class 5 primary engineering controls,
such as laminar airflow workbenches, compounding aseptic isolators, compounding aseptic
containment isolators, and biological safety cabinets, and in all other ISO classified areas is done
once every six months and at any time when microbial contamination is suspected;
• Pressure differential monitoring shall be conducted as required. A pressure gauge or velocity
meter shall be installed to monitor the pressure differential or airflow between the buffer area and the
ante area and between the ante area and the general environment outside the cleanroom. The
 results shall be reviewed and documented on a log at least every work shift (minimum
frequency shall be at least daily) or by a continuous recording device;
• Laminar airflow workbenches, compounding aseptic isolators, compounding aseptic
containment isolators, and biological safety cabinets shall be certified every six months, and
every time they are moved, by an independent certification company to ensure that these primary
engineering controls meet appropriate ISO classifications;
• A cleanroom shall be certified by an independent certification company every six months and
whenever the room or a primary engineering control in the room is relocated or altered, or whenever
major service to the facility is performed, to ensure that the cleanroom meets appropriate ISO
classifications. Such certifications shall be performed consistent with procedures outlined in the
Controlled Environment Testing Association (CETA) Certification Guide for Sterile Compounding
Facilities (CAG-003-2006) (revised December 8, 2008), incorporated herein by reference, as
amended and supplemented, and which may be purchased at the CETA
website, www.cetainternational.org
• Whenever test results indicate that the cleanroom or any primary engineering controls do not meet
the standards established in this section, the pharmacy shall immediately cease using the cleanroom
or primary engineering control that is out of compliance until such time that the cleanroom and/or the
primary engineering control meets the requisite standards. Test results indicating non-compliance
with the requisite standards shall require re-evaluation of all procedures associated with the
production of compounded sterile preparations in the impacted cleanroom or primary engineering
control and documentation with respect to the period of time that the cleanroom and/or primary
engineering control was out of compliance.

5.12.25 Disposal of drugs and materials (11.25)

All unused drugs and materials used in the compounding of preparations, including antineoplastic
agents, shall be disposed of properly in accordance with accepted professional standards and
applicable laws, including the Medical Waste Act (N.J.S.A. 13:1E-48.1 et seq., P.L. 1989, c.34), so
as not to endanger the public health.

5.12.26 Security (11.26)

The compounding area and its contents and other areas where compounded preparations are
present shall be secured, so as to prevent access by unauthorized personnel.

5.13 Compounding Non-Sterile Preparations in Retail and

Institutional Pharmacies
5.13.1 Purpose and scope (11A.1)
The rules in this subchapter regulate the practice of non-sterile compounding and shall apply to all
retail and institutional pharmacies that compound and dispense non-sterile preparations.

5.13.2 Select Definitions (11A.2)

"Compounding" means the preparation, mixing, assembling, packaging, and labeling of a drug or
device as the result of a practitioner's prescription or medication order or initiative based on the
relationship of the practitioner or patient with the pharmacist 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 also includes the preparation of drugs or devices in anticipation of
prescriptions or medication orders based on routine, regularly observed, prescribing patterns.
 "Compounding pharmacist" means a pharmacist who performs or supervises any part of the
compounding process.

5.13.3 Prohibited compounding (11A.3)

A pharmacist shall not compound preparations that contain drug products that appear on the Federal
Food and Drug Administration's list of Drug Products Withdrawn or Removed from the Market for
Reasons of Safety or Effectiveness, codified at 21 CFR 216.24.
A pharmacist shall not compound any commercially available drug products except as listed below.

5.13.4 Compounding commercially available products (11A.4)

A pharmacist shall not compound commercially available products unless:
• The commercially available product is modified to produce a significant difference, in the
professional judgment of the prescriber, between the compounded product for the patient and the
comparable commercially available product; (e.g., removing a dye that the patient is allergic to) or
• The commercially available product is not available from normal distribution channels in a
timely manner to meet the patient's needs, and the dispensing of the compounded product has been
approved by the prescriber and the patient.
A pharmacist who compounds a commercially available product pursuant to one of the
exceptions shall maintain documentation of the reason for such compounding.

5.13.5 Batch preparation (11A.5)

A pharmacist may compound non-sterile preparations in a quantity that is supported by prior valid
prescriptions or medication orders before receiving a valid written prescription or medication order,
provided the pharmacist can document a history of valid prescriptions subsequently received shortly
thereafter or medication orders that have been generated solely within an established professional
prescriber-patient-pharmacist relationship, and provided the prescription or medication order is
retained on file at the pharmacy. The pharmacist shall document the batch preparation process in
accordance with the requirements of N.J.A.C. 13:39-11A.15 as described below.

5.13.6 Compounded non-sterile preparations for prescriber practice

use (11A.6)
A pharmacy may prepare compounded non-sterile preparations for a licensed prescriber for use in
the prescriber's practice without a prescription consistent with State and Federal laws pertinent to
the prescriber's health care practice.

5.13.7 Preparation of pharmacy generated products (PGPs) for

over-the-counter sale (11A.7)
A pharmacist may prepare a pharmacy generated product to be sold over-the-counter without a
prescription or medication order provided that:
• The product does not contain an ingredient that exceeds allowable strengths and doses for over-the-
counter drugs
• The finished product is not one for which a prescription or medication order is required
• The finished product shall be labeled with the following:
o The product name
o The name of all ingredients
o The strength or quantity of all active ingredients
o The package size
o Directions for use
o The use by date
o The name, address, and telephone number of the pharmacy
o Any ancillary and cautionary instructions, as needed
o As pertinent, the requirements for proper storage
A pharmacy generated product shall
• Be sold directly to the consumer only after professional interaction or consultation between a
pharmacist and the consumer
• Be stored in such a manner as to be inaccessible to the public
• Not be sold to any entity for resale purposes
The preparation of pharmacy generated products shall be documented in accordance with the
requirements of N.J.A.C. 13:39-11A.15(b)1 and 6 through 14 as described below.

5.13.8 Compounding area (11A.8)

A pharmacy that regularly engages in compounding shall have an area specifically designated for
the safe and orderly compounding of drug products. Such area shall allow for the orderly placement
of equipment and materials in order to minimize the potential for errors.
A pharmacy that engages in occasional compounding shall prepare an area prior to each
compounding activity that allows for the safe and orderly compounding of drug products. The area
shall allow for the orderly placement of equipment and materials in order to minimize the potential for
errors.
A pharmacy engaged in compounding shall ensure that:
• All compounding areas are well-lighted and ventilated and are maintained in a clean and sanitary
condition
• Heating and air conditioning systems are controlled to avoid decomposition of chemicals
• Sewage, trash, and other refuse in and from the pharmacy and immediate drug compounding area
are maintained, and disposed of, in a timely, safe, and sanitary manner
• The compounding area is easily accessible to hot and cold running water, exclusive of the bathroom
sink; soap or detergent; and air dryers or single source towels

5.13.9 Equipment and supplies (11A.9)

A pharmacy shall possess equipment appropriate to the type of compounding performed at the
pharmacy.
Equipment used in compounding drug products shall be
• Of appropriate design and capacity, and shall be suitably located to facilitate operations for the
intended use, cleaning, and maintenance of the equipment
• Of suitable composition so as not to be reactive, additive, or adsorptive, so as to alter the safety,
identity, strength, quality, and purity of the compounded produces
• Thoroughly cleaned and sanitized after each use, and when necessary, prior to use, in order to
prevent cross-contamination of ingredients and preparations
• Stored in a manner to prevent cross-contamination of ingredients and preparations
Automated, mechanical, or electronic equipment may be used in compounding non-sterile
preparations. All equipment utilized in compounding non-sterile preparations shall be inspected,
maintained, and validated at appropriate intervals, consistent with manufacturer's recommendations,
to ensure the accuracy and reliability of equipment performance.
When antineoplastic agents and hazardous substances are utilized in the compounding of non-
sterile preparations, a pharmacy shall adhere to standards established by the Occupational Health
and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA's Technical Manual on
Controlling Occupational Exposure to Hazardous Drugs (effective date January 20, 1999). OSHA's
Technical Manual is incorporated herein by reference, as amended and supplemented, and can be
found at the OSHA website, www.osha.gov,
specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the
standards established by National Institute for Occupational Safety and Health (NIOSH) in NIOSH
Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other
Hazardous Drugs in Health Care Settings. The NIOSH standard is incorporated herein by reference,
as amended and supplemented, and can be found at the CDC website, www.cdc.gov,
specifically, www.cdc.gov/niosh/docs/2004-165/.
• Hazardous substances are those substances identified as hazardous in NIOSH Publication No.
2004-165, Appendix A.

5.13.10 Responsibilities of the compounding pharmacist; reporting

requirement (11A.10)
A compounding pharmacist shall be responsible for the ensuring that:
• Compounded non-sterile preparations have been properly prepared, labeled, controlled, stored,
dispensed, and distributed
• All aspects of the compounding process set out in N.J.A.C. 13:39-11A.15 as described below are
documented and that accurate compounding records for all compounded non-sterile preparations
prepared by the pharmacy are maintained
• Compounding personnel are capable of performing and qualified to perform their assigned duties
• Ingredients used in compounding have their expected identity, quality, and purity
• Compounded preparations are of acceptable strength, quality, and purity, with appropriate
packaging and labeling, and are prepared in accordance with good compounding practices, official
standards, and relevant scientific data and information
• Critical processes are recorded and validated to ensure that procedures will consistently result in the
expected qualities in the finished preparation
• The compounding environment is suitable for its intended purpose
• Appropriate stability evaluation is performed or is determined from the literature for establishing
reliable beyond-use dating to ensure that the finished preparations have their expected potency,
purity, quality, and characteristics, at least until the labeled beyond-use date
• Compounding conditions and procedures are in place to minimize the potential for errors
• Adequate procedures and records exist for investigating and correcting failures or problems in
compounding, testing, or in the preparation itself
• The patient is advised that the product dispensed is a compounded preparation.
Any confirmed incidents of product contamination shall be reported by the pharmacist-in-
charge to the New Jersey Board of Pharmacy within 48 hours of becoming aware of any such
incidents.

5.13.11 Beyond-use dates (11A.11)

The beyond-use date is the date after which a compounded non-sterile preparation shall not be
used. The beyond-use date shall be determined from the date the preparation is compounded.
Because compounded preparations are intended for administration immediately or following short-
term storage, beyond-use dates may be assigned based on criteria different from those applied to
assigning expiration dates to manufactured drug products.
In the absence of stability information that is applicable to a specific drug product and preparation,
the following are the maximum beyond-use dates for non-sterile compounded drug preparations that
are packaged in tight, light-resistant containers and stored at controlled room temperature unless
otherwise indicated:
• For nonaqueous liquids and solid formulations:
o Where the manufactured drug product is the source of the active ingredient, the beyond-use date
shall not be later than 25 percent of the time remaining until the product's expiration date or six
months, whichever is earlier;
o Where a United States Pharmacopeia-National Formulary (USP-NF), analytical reagent (AR),
certified American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substance is the
source of the active ingredient, the beyond-use date shall not be later than six months or the
expiration date of the ingredient, whichever is earlier; and
o Where there is more than one ingredient, the beyond-use date shall be no longer than six months or
the expiration date of the first ingredient to expire, whichever is earlier;
• For water-containing formulations (prepared from ingredients in solid form), the beyond-use
date shall not be later than 14 days for liquid preparations when stored at cold temperatures
between two degrees and eight degrees Celsius (36 degrees and 46 degrees Fahrenheit)
• For all other formulations, the beyond-use date shall not be later than the intended duration
of therapy or 30 days, whichever is earlier.
The beyond-use date limits may be exceeded only when there is supporting valid scientific stability
information that is directly applicable to the specific preparation (that is, the same drug concentration
range, pH, excipients, vehicle, water content, etc.).

5.13.12 Ingredient selection (11A.12)

All ingredients used to compound non-sterile preparations shall be United States Pharmacopeia-
National Formulary (USP-NF), analytical reagent (AR), certified American Chemical Society (ACS),
or Food Chemicals Codex (FCC) grade substances. If a USP-NF, AR, ACS, or FCC grade
substance ingredient is not available, the pharmacist shall establish the purity and safety of the
ingredient by reasonable means, which may include lot analysis, manufacturer reputation, or
reliability of source study.
A manufactured drug product may be utilized as the source of an active ingredient. Only
manufactured drug products from containers labeled with a batch control number and an unexpired
expiration date shall be utilized as sources of active ingredients. When compounding with
manufactured drug products, the compounding pharmacist shall consider all ingredients present in
the drug product relative to the intended use of the compounded non-sterile preparation.
 Components used in the compounding of non-sterile preparations such as aliquots, triturates, stock
solutions, buffering agents, or isotonic solutions may be prepared in advance and stored as
pharmacy stock. The preparation of such products shall be documented in accordance with the
requirements of N.J.A.C. 13:39-11A.15(b)1 and 6 through 14 as described below.

5.13.13 Information required to appear on prescription label

(11A.13)
The dispensed container for any compounded non-sterile preparation shall bear a permanently
affixed label with at least the following information:
• In a retail pharmacy only, the name of the prescriber
• An institutional pharmacy compounding non-sterile preparations for out-patient use shall include the
name of the prescriber on the label
• The name of the patient
• The name of all active ingredients
• Directions for use
• The use by date
• The name, address, and telephone number of the pharmacy
• Any ancillary and cautionary instructions as needed
• As pertinent, the requirements for proper storage

5.13.14 Pharmacy technicians, pharmacy interns, and pharmacy

externs; required supervision (11A.14)
The compounding pharmacist shall provide immediate personal supervision to pharmacy
technicians, pharmacy interns, or pharmacy externs who are performing non-sterile preparation
compounding. Supervision shall include, but is not limited to, the checking of each ingredient used,
the quantity of each ingredient whether weighed, measured, or counted, and the finished label.
The compounding pharmacist may delegate to pharmacy technicians, pharmacy interns, or
pharmacy externs only the following tasks:
• Recording of the prescription
• Selection of the drugs and container
• Typing of labels
• Compounding of preparations
The compounding pharmacist shall ensure that each task has been performed correctly.

5.13.15 Audit trail; compounding record documentation (11A.15)

(a) A pharmacy shall maintain an audit trail for all non-sterile compounded preparation prescriptions
dispensed.
(b) Except as provided below, a pharmacy shall maintain a compounding record for each
compounded non-sterile preparation that contains the following information:
1. Selection of the ingredients and documentation of source, lot numbers, and expiration dates
of all ingredients used;
2. Verification that ingredients comply with the prescription or medication order;
 3. Verification that the prescription or medication order label complies with the requirements of
N.J.A.C. 13:39-11A.13;
4. Verification that the prescription or medication order is complete and ready to be dispensed,
including any necessary ancillary supplies;
5. Strength of preparation;
6. Date of preparation;
7. Name or personal identifier of the person(s) who performed each step of the compounding
process and the compounding pharmacist(s) who verified the preparation;
8. Reference(s) for formulation, if available;
9. Total quantity;
10. Detailed steps of the compounding process to ensure that the exact same compound can
be duplicated at a future date;
11. Type of dispensing container used when a drug has specific storage requirements;
12. Beyond-use date of the finished product consistent with the requirements in N.J.A.C.
13:39-11A.11;
13. The assigned internal identification number for the preparation or the prescription number;
and
14. Instructions for use, storage, and handling of the compounded preparation.
A compounding record shall not be required for:
• Mixing, reconstituting, or assembling a drug according to the product's labeling or the manufacturer's
directions
• Product flavoring

5.14 Nuclear Pharmacies

5.14.1 Definitions (12.1)
“Authentication of product history’’ includes, but is not limited to, identifying the purchase
source, the ultimate use or disposition and any intermediate handling of any components of a
radiopharmaceutical.
“Authorized practitioner’’ means a practitioner duly authorized by applicable Federal and State
law to possess, use and administer radiopharmaceuticals.
“Designated agent’’ means an individual under the direct supervision of a
practitioner authorized to communicate the practitioner’s instructions to the nuclear pharmacy.
“Immediate personal supervision’’ means that the pharmacist is physically present in the
compounding/ dispensing area where interns, externs, and pharmacy technicians are performing
delegated duties, and conducts any necessary in-process and the final check in preparation and
compounding of medications, including the checking of each ingredient used, the quantity of each
ingredient whether weighed, measured or counted, and the finished label.
“Internal test assessment’’ includes, but is not limited to, conducting those tests necessary to
insure the integrity of the test.
 “Radiopharmaceutical’’ means any substance defined as a drug in Section 201(g)(1) of the
Federal Food, Drug and Cosmetic Act or in the FDA’s Nuclear Pharmacy Guidelines and which
exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or
photons and includes any such drug which is intended to be made radioactive. This definition
includes nuclide generators which are intended to be used in the preparation of any such
substance but does not include drugs such as carbon-containing compounds or potassium-
containing compounds or potassium-containing salts which contain trace quantities of naturally
occurring radionuclides.
“Radiopharmaceutical quality assurance’’ includes, but is not limited to, the performance of
appropriate chemical, biological and physical tests on radiopharmaceuticals and the
interpretation of the resulting data to determine their suitability for use in humans and
animals, including internal test assessment, authentication of product history and
the keeping of proper records.
“Radiopharmaceutical service’’ includes, but is not limited to, the compounding, dispensing,
labeling and delivery of radiopharmaceuticals; the participation in radiopharmaceutical utilization
reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance of
radiopharmaceutical quality assurance; and the offering of those acts, services, operations or
transactions necessary in the conduct, operation, management and control of a nuclear pharmacy.

5.14.2 General Requirements for Pharmacies Providing

Radiopharmaceutical Service (12.2)
All personnel performing tasks in the preparing and distribution of drugs shall be under
the immediate personal supervision of the nuclear pharmacist who shall be responsible for all
nuclear operations of the licensed area and shall be in personal attendance at all times when the
nuclear pharmacy is open for business. Nuclear pharmacies shall maintain an audit trail that
records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy
technician(s), intern(s) or extern(s) performing the radiopharmaceutical services. The collection of
demographic information for the patient profile is not required to be included in the audit trail.
The nuclear pharmacy shall be separate from the pharmacy areas for non-radioactive drugs and
shall be inaccessible to all unauthorized personnel. All pharmacies handling radiopharmaceuticals
shall be provided with a radioactive storage and decay area. A nuclear pharmacy dispensing
radioactive drugs may be exempted from the general space requirements for pharmacies.
The process used for handling radioactive materials by any license holder must involve appropriate
procedures for the purchase, receipt, storage, manipulation, compounding, distribution, and disposal
of radioactive materials. In order to ensure the public health, safety, and welfare, a nuclear
pharmacy shall first meet the following general requirements:
• The environment where the handling of radioactive materials takes place shall be properly ventilated
so that radioactive materials cannot be airborne from that environment to other non-occupationally
unrestricted areas;
• The environment shall be properly located so that the receipt and dispersal of radioactive materials
does not result in inadvertent and undesired contamination of other non-occupationally labeled
areas; and
• The area shall be designed in such a manner that radioactive materials can be contained in given
areas to ensure adequate safety and protection to personnel working in or near them and to insure
proper operation of the corresponding assay equipment.
 5.14.2.1 Labeling Requirements for immediate outer container

• The standard radiation symbol

• The words, “CAUTION RADIOACTIVE MATERIAL’’
• The radionuclide
• The chemical form
• The amount of radioactive material contained in millicuries or microcuries
• If a liquid, the volume in milliliters
• The requested calibration time for the radioactivity contained
• The name, address, and telephone number of the nuclear pharmacy
• The prescription number
• The date and patient’s name, if available
5.14.2.2. Labeling Requirements for immediate container

• The standard radiation symbol

• The words, “CAUTION” RADIOACTIVE MATERIAL’’
• The name of the radiopharmaceutical
Nuclear pharmacies shall only dispense radiopharmaceuticals that comply with acceptable
professional standards of radiopharmaceutical quality assurance.
A nuclear pharmacist may transfer to authorized persons and United States Nuclear Regulatory
Commission licensed medical practitioners radioactive materials not intended for drug use, in
accordance with the regulations of the United States Nuclear Regulatory Commission or its
successor. A nuclear pharmacy may furnish radiopharmaceuticals to these practitioners for patient
use.
Nuclear pharmacies shall comply with all applicable laws and regulations of Federal and State
agencies including those laws and regulations governing non-radioactive drugs. For nuclear
pharmacies handling radiopharmaceuticals exclusively, the Board of Pharmacy may waive
rules pertaining to pharmacy permits for nonradiopharmaceuticals which requirements do
not pertain to the practice of nuclear pharmacy.
Radioactive drugs are to be dispensed only upon a non-refillable prescription order from a
United States Nuclear Regulatory Commission licensed medical practitioner (or the designated
agent) authorized to possess, use and administer radiopharmaceuticals.
Prescription orders for delivery of radioactive drugs for use in the medical practice of a United States
Nuclear Regulatory Commission licensed medical practitioner may be placed on a telephone
answering and recording device, only if the practitioner (or the designated agent) is identified in such
a manner that is clearly recognized by the nuclear pharmacist dispensing the radioactive drug.
A qualified nuclear pharmacist shall have the authority to delegate to any qualified and
properly trained person or persons, acting under his or her immediate personal supervision,
any nuclear pharmacy act which a reasonable and prudent pharmacist would find is within
the scope of sound pharmaceutical judgment to delegate. Such delegation may only occur if, in
the professional opinion of the qualified nuclear pharmacist, the act may be properly and safely
performed by the person to whom the pharmacy act is delegated. The delegated act may only be
 performed in its customary manner, not in violation of other statutes. The person to whom a nuclear
pharmacy act is delegated shall not hold himself or herself out to the public as being authorized to
practice pharmacy.

5.14.3 General Requirements for a Nuclear Pharmacist

(12.3)
• Pharmacist licensed to practice in the State of New Jersey
• Meets minimal standards of training and experience (United States Nuclear Regulatory
Commission and NJ Bureau of Radiation Protection

5.14.4 Minimum Requirements for Space, Equipment,

Supplies, and Library (12.4)
5.14.4.1 Space Requirements

• The area for the storage, compounding and dispensing of radioactive drugs shall be completely
separate from pharmacy areas for non-radioactive drugs
• Hot lab and storage area shall be a minimum of 120 square feet
• The compounding and dispensing area shall be a minimum of 300 square feet
5.14.4.2 Minimum Required Equipment
• Dose calibrator
• Refrigerator;
• Drawing station
• Well scintillation counter
• Microscope
• Chromatographic apparatus or comparable means of effectively assuring tagging efficiency
• Radiation survey equipment of the appropriate type and calibration to detect quantities of radioactive
materials as prescribed in the appropriate radioactive material licenses
• Other equipment deemed necessary for radiopharmaceutical quality control for products
compounded or dispensed as may be determined by the United States Nuclear Regulatory
Commission or its successor and the State of New Jersey Bureau of Radiation Protection
5.14.4.2 Required Reference Texts

• An up-to-date, comprehensive pharmaceutical reference text(s) and suitable reference texts

encompassing the general practice of pharmacy, drug interactions, drug product
composition and patient counseling. Unabridged computerized versions of these reference
texts shall be acceptable
• State statutes and rules relating to pharmacy
• State and Federal regulations governing the use of applicable radioactive materials
• Text relating to the practice of nuclear pharmacy and radiation safety

5.14.5 Quality Control (12.5)

Nuclear pharmacy permit holder shall be responsible for the radioactive quality control of all
drugs, including biologicals, dispensed or manufactured. Radioactive pharmaceutical quality
controls include, but are not limited to, the carrying out and interpretation of data resulting
 from chemical, biological and physical tests on potentially radioactive pharmaceuticals to
determine the suitability for use in humans and other animals, including internal test assessment
and authentication of product history.

5.15 Collaborative Practice

5.15.1 Definitions (13.2)
"Collaborative practice" means that practice of pharmacy whereby one or more pharmacists have
jointly agreed to work in conjunction with one or more physicians for the purpose of collaborative
drug therapy management of patients.
"Collaborative practice protocol" means a written document that identifies the CDTM actions that
a pharmacist is authorized to perform for a patient and that is developed jointly by the pharmacist
and the physician and meets the requirements outlined in N.J.A.C. 13:39-13.5 as described below.
"Informed consent" means the written document that is signed by a patient whereby the patient
agrees to CDTM by the patient's physician and a pharmacist who has entered into a collaborative
practice agreement with the physician.
"Therapeutic interchange" means the substitution and dispensing of a drug chemically dissimilar
from the prescription drug originally prescribed.

5.15.2 Board Approval; Pharmacist Qualifications; Continuing

Education (13.3)
5.15.2.1 Pharmacist Qualifications

A licensed pharmacist shall be pre-approved by the Board by submitting a collaborative practice

application and documentation of successful completion of one of the following:
• A certificate training program offered by an ACPE provider
• A post-graduate residency program accredited by the ASHP, or
• A certification program from the Board of Pharmacy Specialties
5.15.2.2 Continuing Education Requirements

• Complete a minimum of 10 credits of continuing education every biennial renewal period in

each disease(s) or condition(s) covered by the collaborative practice agreement(s) to which he or
she is a party
However, to the extent that a pharmacist may enter into collaborative practice agreements to treat
patients with co-existing, interrelated conditions or diseases, a pharmacist need only complete a
total of 10 credits in the interrelated conditions or diseases.

5.15.3 Collaborative Practice Agreement (13.4)

A pharmacist who engages in collaborative practice with one or more physicians shall provide the
Board, upon request, with a signed copy of a collaborative practice agreement. The written
agreement shall:
• Identify, by name and title, each physician and each pharmacist who is permitted to participate in a
patient's CDTM, including all covering physicians and/or pharmacists. The agreement shall establish
the means by which the physician and/or pharmacist will be notified about covering practitioners for
collaborative practice purposes.
• Specify the functions and responsibilities, including the scope of practice and authority, to be
exercised by the pharmacist
• Indicate any restrictions on use of certain drugs or drug therapies
• Indicate any diagnosis or diseases that are specifically included or excluded
• Include copies of all protocols to be used in the collaborative practice
• Contain an effective date for the agreement
• Be signed and dated by the physician(s) and pharmacist(s)
The collaborative practice agreement may be terminated at any time by either the physician or the
pharmacist by written documentation. Upon termination of a collaborative practice agreement, the
physician and the pharmacist shall provide notice to each applicable patient.
All records relating to a collaborative practice agreement shall be maintained in either hard copy or
electronic form for a period of not less than seven years from the date of termination of the
agreement and shall be supplied to the Board upon request. All records shall be made available to
persons authorized to inspect them under State and Federal statutes and regulations. Records not
currently in use need not be stored in the pharmacy, but the storage facilities shall be secure. Patient
records shall be kept confidential.

5.15.4 Collaborative Practice Protocols (13.5)

A collaborative practice protocol shall be developed for each different type of CDTM
authorized by the physician under the collaborative practice agreement and shall identify those
activities that may be performed by the collaborating pharmacist. Each protocol shall:
• Be jointly developed by the physician and the pharmacist, and be signed and dated by both the
physician and the pharmacist
• Be initiated and utilized at the sole discretion of the physician for a specific patient with whom the
physician has a bona fide physician-patient relationship
• Be agreed to by both the physician and the pharmacist with the written informed consent of the
patient
• Be available at the practice sites of the pharmacist and physician and made available at each site to
the patient
• Establish the means by which the patient will be advised of the right to elect to participate in and
withdraw from the CDTM
• Establish when physician notification is required, the physician chart update interval, and an
appropriate time frame within which the pharmacist shall notify the physician of any change in dose,
duration, or frequency of medication prescribed. Written notification, by either facsimile or
electronic means, shall be provided to the physician no later than eight hours after any change in
prescribed medication is made by the pharmacist.
• Identify the method and time frame for notification of the physician if an adverse event occurs
• Be reviewed at least once per year by the parties to determine whether the protocol should be
renewed, modified, or terminated
 5.15.5 Informed Consent for Collaborative Drug Therapy
Management (13.6)
Written informed consent shall be obtained from each individual patient participating in CDTM.
Both the physician and the pharmacist shall retain a copy of the patient's written informed consent.
The written informed consent shall:
• Contain the specific patient's name
• Identify the risks and benefits of CDTM, including the fact that services provided under collaborative
drug therapy management may not be covered by the patient's insurance provider
• Identify the fact that covering physicians and/or pharmacists may be utilized in the CDTM of the
patient's care
• Identify the patient's right to elect to participate in and withdraw from the CDTM
• Be signed and dated by the patient

5.15.6 Scope of Collaborative Drug Therapy Management (13.7)

CDTM shall be between a single patient with whom the physician has a bona fide physician-patient
relationship, the physician, and the patient's collaborative practice pharmacist(s) and shall address
that patient's specific condition, disease or diseases.
CDTM may include the collecting, analyzing, and monitoring of patient data, ordering or performing
of laboratory tests based on the standing orders of a physician as set forth in the written
collaborative practice protocols, ordering of clinical tests based on the standing orders of a physician
as set forth in the written collaborative practice protocols; modifying, continuing, or discontinuing
drug or device therapy; and therapeutic drug monitoring with appropriate modification to dose,
dosage regimen, dosage forms, or route of administration.
A pharmacist may perform laboratory tests that are granted waived status in accordance with the
provisions of the "New Jersey Clinical Laboratory Improvement Act, Department of Health and
Senior Services' rules set forth at N.J.A.C. 8:44, and Department of Health and Senior Services
CLIA Program requirements, available at http://www.nj.gov/health/phel/clinical-lab-imp-services/,
provided the tests are consistent with the pharmacy practice area or disease state covered by the
collaborative practice agreement.
The interpretation of clinical or laboratory tests under a written collaborative practice protocol shall
be performed by a pharmacist only in direct consultation with a physician.
CDTM shall not include therapeutic interchange at the time of dispensing without the prior,
specific informed consent of the patient and the consent of the patient's physician. Written
confirmation of the consent, which may be by electronic means, shall be maintained at the
pharmacy practice site of the collaborating pharmacist.

5.15.7 Voluntary Participation(13.8)

Participation in, or withdrawal from, a collaborative practice agreement shall be voluntary on the part
of a physician and a pharmacist as well as the individual patient.

5.15.8 Failure To Comply (13.9)

Any violation of the collaborative practice agreement or protocols on the part of the pharmacist may
be deemed professional misconduct and may subject the pharmacist to discipline.
 Collaborative Practice Regulations were proposed as of March 19, 2012 and finally
approved on February 4, 2013.

5.16 Sale of Dextromethorphan to Minors

5.16.1 Overarching sale restrictions
An act concerning the sale of dextromethorphan to minors, P.L. 2015, c. 114, became effective on
February 1, 2016. It states in N.J.S.A 2A:170-51.7 that the sale of dextromethorphan to persons
under 18 prohibited; and describes the violations and associated penalties.
No person shall sell or offer for sale, either directly or indirectly by an agent or employee, any
product containing dextromethorphan as an active ingredient to a person under 18 years of age.

5.16.2 Pharmacist Defenses to Prosecution

▪ The purchaser of the product falsely represented, by producing either a driver’s license or non-driver
identification card issued by the New Jersey Motor Vehicle Commission, a similar card issued
pursuant to the laws of another state or the federal government or Canada, or a photographic
identification card issued by a county clerk, that the purchaser was of legal age to make the
purchase
▪ The appearance of the purchaser of the product was such that an ordinary prudent person would
believe the purchaser to be of legal age to make the purchase
▪ The sale of the product was made in good faith, relying upon the production of the identification set
forth above, the appearance of the purchaser, and the reasonable belief that the purchaser was of
legal age to make the purchase

5.16.3 Penalties for Violations

A person who violates the above provisions, including an employee of a retail establishment who
actually sells a product containing dextromethorphan as an active ingredient to a person under 18
years of age, shall be liable to a civil penalty of not more than $750. In the case of a retail
establishment that is part of a chain with two or more locations in the State, the violation shall be
assessed against the particular retail establishment and not the chain.
This law does not affect prescriptions written for Dextromethorpham for individuals
of any age, which would be permitted.

The Department of Health will maintain a list of all products that contain
Dextromethorphan on its website.

5.17 Sale and Possession of Syringes and Needles

A licensed pharmacy may sell a hypodermic syringe or needle to a person over 18 years of age who
presents valid photo identification to demonstrate proof of age or who otherwise satisfies the seller
that he is over 18 years of age, as follows:
▪ Without a prescription if sold in quantities of 10 or fewer; and
▪ Pursuant to a prescription issued by a person authorized to prescribe under State law if sold in
quantities of more than 10
A licensed pharmacy that provides hypodermic syringes or needles for sale shall also be required to:
▪ Maintain its supply under or behind the pharmacy sales counter such that they are accessible only to
a person standing behind a pharmacy sales counter
▪ Make available to each person who purchases any such instrument, at the time of purchase,
information to be developed by the Department of Health and Senior Services to the purchaser,
about:
Safe disposal of the instrument, including local disposal locations or a telephone
number to call for that information
Substance abuse treatment, including a telephone number to call for assistance in
obtaining treatment
 6. GENERIC SUBSTITUTION

6.1 Generic Substitution

Drug products, with therapeutic equivalence ratings of "A," identified by the Food and Drug
Administration in "Approved Drug Products with Therapeutic Equivalence Evaluations," incorporated
herein by reference, commonly known as the "Orange Book," shall serve as the list of
interchangeable drug products required by N.J.S.A. 24:6E-1 et seq. The Orange Book is available
on-line at http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
Drug products approved by the FDA with therapeutic equivalence ratings of "A" that appear on the
FDA's "Drugs@FDA" website, bearing formal internet
address http://www.accessdata.fda.gov/scripts/cder/daf/, supplement the list of interchangeable drug
products required by N.J.S.A. 24:6E-1 et seq.
Please note that there is not really a difference between the Orange Book and the Drugs @ FDA
website. The only difference is that the Drugs @ FDA website gets updated daily while the Orange
Book gets updated monthly. So the only effective difference between the 2 publications is that
interchangeable drug products will appear sooner in the Drugs @ FDA website.

Rule making authority for generic substitution in the State of New Jersey is under the
purview of the Department of Health, not the Board of Pharmacy

6.2 Biosimilars
New Jersey passed a law that went into effect January 1, 2016, describing the scope of pharmacist
authority in the area of biosimilars. A pharmacist may substitute a biological product for a prescribed
biological product when
▪ The authorized prescriber has not indicated that there shall be no substitution, and
▪ The biological product to be substituted is FDA-approved to be interchangeable with or
therapeutically equivalent to the prescribed biological product
Pharmacists will then be required to
▪ Notify the prescriber (via written, telephonic, or electronic notification), within five business days, of
the specific product provided to the patient, including the name of the product and the manufacturer
▪ Record on the prescription label and record of dispensing the product name and manufacturer of the
biological product dispensed, followed by the words “Substituted for” and the name of the prescribed
biologic
No communication shall be required to the prescriber when there is no biological product that has
been determined by the federal Food and Drug Administration to be either:
• Interchangeable with the product prescribed or
• Therapeutically equivalent to the product prescribed or
• A refill prescription is not changed from the product dispensed on the prior filling of the prescription
Pharmacists who meet these requirements in dispensing and substituting a biological product for its
reference product would incur no greater liability for dispensing the substituted product than would
be incurred for dispensing the prescribed product.
 7. LONG TERM CARE REGULATIONS
7.1 Long Term Care Regulations (8:39-29)
7.1.1 Mandatory Pharmacy Organization (29.1)
A facility shall have a consultant pharmacist, and either a provider pharmacist or, if the facility
has an in-house pharmacy, a director of pharmaceutical services.
The facility shall have an interdisciplinary pharmacy and therapeutics committee, of which the
consultant pharmacist is a member. The committee may include a licensed pharmacist representing
the provider pharmacy. Other members of the committee include the administrator, a member of the
nursing staff, with oversight by the medical director as needed. The committee shall
hold meetings as needed but at least quarterly and records, including the dates of meetings,
attendance, activities, findings, and recommendations, shall be maintained.
The consultant pharmacist cannot be the director of pharmaceutical services or the pharmacist
provider nor can he/she be affiliated with either the director of pharmaceutical services or the
pharmacist provider.
If the facility keeps, emergency injectable or oral controlled substances, a current DEA registration
and CDS registration for that location shall be available.

7.1.2 Mandatory Drug Administration Policies and

Procedures (29.2)
The P&T committee shall establish and enforce procedures for documenting drug administrations.
The facility shall have a system to accurately identify recipients before any drug is administered.
Self-administration of drugs shall be permitted by qualified residents only as specified by the
policy of the P&T committee and assessment of the interdisciplinary team. Self-administration
procedures shall include, at a minimum, the following:
• The written order of the prescriber
• Storage of medications in the resident's room
• Specifications for labeling, including directions for use
• Methods for documentation in the medical record
• Training of residents in self-administration
• Policies for assessment of residents ability to self-administer medications
Medications shall be accurately administered and documented by properly authorized individuals, as
per prescribed orders and stop order policies.

7.1.3 Mandatory Pharmacy Reporting Policies and

Procedures (29.3)
The consultant pharmacist shall conduct a drug regimen review and enter appropriate
comments into the medical record of every resident receiving medication, at least monthly.
 The consultant pharmacist shall report any irregularities promptly to the attending physician or
advanced practice nurse and to the director of nurses and these reports shall be acted upon. These
reports shall include, but are not limited to, problems and recommendations about drug therapy
which may be affected by biologicals, laboratory tests, special dietary requirements and foods used
or administered concomitantly with other medication to the same recipient. Also, these reports are
required to include monitoring for potential adverse effects, allergies, drug interactions,
contraindications, rationale, and drug evaluation.
Drug product defects and adverse drug reactions shall be reported in accordance with the
ASHP-USP-FDA American Society of Health System Pharmacists, United States Pharmacopoeia,
Food and Drug Administration Drug Product Defect Reporting System and the USP Adverse Drug
Reaction Reporting System.
All known drug allergies shall be documented in the resident's medical record including the
medication administration records and physician or advanced practice nurse order sheets and on the
outside front cover and communicated to the provider or dispensing pharmacy.
Drugs that are not specifically limited as to duration of use or number of doses shall be controlled
by automatic stop orders. The resident's attending physician or advanced practice nurse shall be
notified of the automatic stop order prior to the last dose so that he or she may decide whether to
continue use of the drug.
If medication is withheld, the reason for withholding the medication shall be documented in the
resident's medical record.
Medication errors and adverse drug reactions shall be reported immediately to the director of
nursing or the alternate to the director of nursing, and a description of the error or adverse drug
reaction shall be entered into the medical record before the end of the employee shift. If the
resident has erroneously received medication, the resident's physician or advanced practice nurse
shall be notified immediately. If a medication error originated in the pharmacy, the pharmacy shall
be notified immediately. The Department shall be notified of an adverse drug reaction that
results in death.

7.1.4 Mandatory Pharmacy Control Policies and

Procedures (29.4)
The label of each resident's, individual medication container or package shall be labeled in
accordance with the NJ State Board of Pharmacy regulations, permanently affixed, and contain the
following information:
• The resident's full name
• The prescriber's name
• The prescription number
• The name and strength of drug
• The quantity dispensed
• The lot number
• The date of issue
• The expiration date
• The manufacturer's name if generic
• Cautionary and/or accessory labels
• The name, address, and telephone number of the pharmacy
7.1.4.1 Unit Dose Drug Distribution Requirements

• Each resident shall have his/her own medication tray labeled with the resident’s name and location
in the facility
• Each medication shall be individually wrapped and labeled with the generic or trade (brand name)
and strength of the drug, lot number or reference code, expiration date, dose, and manufacturer’s
name
• Cautionary instructions or special times for administration, etc. shall appear on the patient’s record of
medication
• Delivery and exchange of medication trays shall occur promptly, and if a 24 hour system is used,
then at least one exchange every 24 hours
• A limited number of otc and prescription medications may be kept as stock for stat doses, lost doses,
etc.
o These medications shall be approved by the P&T committee, monitored for accountability, and
labeled to include drug name, drug strength, manufacturers' name, lot number, expiration date,
recommended dosage for over-the-counter medications, and applicable cautionary and/or accessory
labels
7.1.4.2 Consultant Pharmacist Responsibilities

• Make monthly inspections of all areas of the facility where medications are dispensed, administered
or stored
• Periodically (as Per P&P) observe a medication pass and review the crediting system
• Document any problems and propose solutions
7.1.4.3 Emergency Kits

The P&T committee shall have approved the contents of the emergency kits. The emergency kits
shall be:
• Securely stored at each nursing unit, but not under lock and key
• Checked after each use
• Checked at least monthly by the consultant pharmacist
7.1.4.4 Miscellaneous Requirements

All medications repackaged by the pharmacy shall be labeled with an expiration date, name and
strength of drug, lot number, date of issue, manufacturer’s name if generic, and cautionary labels.
The P&T committee shall establish and enforce procedures for removal of discontinued, unused,
expired, recalled, deteriorated, and unlabeled drugs, and IV solutions and removal of containers of
medications with worn, illegible, etc. labels.
All medications shall be stored in accordance with manufacturers' and U.S.P. requirements and all
medications shall be kept in locked storage areas.
 All medication destruction in the facility shall be witnessed by at least 2 persons, each of whom shall
be the pharmacist consultant, a registered professional nurse, or a licensed practical nurse. A
record of each instance of destruction shall be maintained.

7.1.5 Mandatory Resident Pharmacy Services (29.6)

The facility shall provide pharmaceutical services, either directly or by contract with a provider
pharmacy, 24 hours a day, seven days a week.
If a resident obtains medications from a pharmacy that is not the facility provider pharmacy:
• The pharmacy provider shall comply with all labeling requirements described above under (29.4)
• The facility shall establish a plan for obtaining the resident's drugs on an emergency basis
A resident may obtain medications from a pharmacy that is not the facility provider pharmacy unless:
• The resident is expressly informed within the admission agreement that this service is not permitted
in the facility or
• For existing residents, the facility submits documentation to the Department, prior to denying the
request, demonstrating a significant risk to the health and safety of residents as a result of this
practice

7.1.6 Mandatory Pharmacy Quality Assurance (29.8)

The pharmacy and therapeutics committee shall review reports of medication errors and suspected
adverse drug reactions and shall summarize these reports yearly.