COMMUNITY FOCUS:

COMPOUNDING PHARMACY
IN THE COMMUNITY SETTING
SATURDAY/11:30AM-12:30PM

ACPE UAN: 0107-9999-16-035-L04-T 0.1 CEU/1 hr

Activity Type: Knowledge-Based

Learning Objectives for Pharmacy Technician: Upon completion of this CPE activity participants should be able
to:
1. List services that may be provided by a compounding pharmacy
2. Describe the state and national regulations that apply to a compounding pharmacy
3. Identify the role of the pharmacy technician in compounding services in the community pharmacy
setting
4. List resources that may be helpful when providing compounding services at your pharmacy

Speaker: Tricia Morrical, RPh

Tricia Morrical is a compounding pharmacist at Dakota Dunes Family Pharmacy in Dakota Dunes, South
Dakota. Tricia graduated from Creighton University School of Pharmacy in 1995 with a BSPharmacy. She
has worked in a variety of pharmacy practices including chain retail pharmacy, long term pharmacy, and
hospice consulting. She enjoys working with patients and prescribers to find solutions to medication
challenges.

Speaker Disclosure: Tricia Morrical reports no actual or potential conflicts of interest in relation to this CPE
activity. Off-label use of medications will not be discussed during this presentation.

FEBRUARY 13, 2016 | IOWA EVENTS CENTER | DES MOINES, IOWA

 Compounding Pharmacy in the Community
Setting
Tricia Morrical, RPh

Disclosure
Tricia Morrical reports no actual or potential conflicts of interest
associated with this presentation.

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Learning Objectives
Upon successful completion of this activity, technicians
should be able to:

1. List services that may be provided by a compounding

pharmacy
2. Describe the state and national regulations that apply
to a compounding pharmacy
3. Identify the role of the pharmacy technician in
compounding services in the community pharmacy setting
4. List resources that may be helpful when providing
compounding services at your pharmacy

Compounding Services
Compounding Pharmacies: Have specialized
equipment to compound whatever is needed.

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Compounding Services
Retail Pharmacies can incorporate sophisticated
compounding into their practice as well.

Compounding Services
Sterile
Nasal/Body Irrigations; Gentamicin/Normal Saline
Irrigation (Wilsons Solution)
Ophthalmic preparations; Vancomycin Ophthalmic
Drops
Injectable/Intravenous; Methylcobolamin
Requires:
extensive documentation
certification of personnel at least biannually
certification of equipment at least biannually

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Compounding Services
Non-Sterile
Creams/Ointments
Pain Creams
Hormone Replacement Creams
(Estrogen/Testosterone/Progesterone/DHEA)
Nifedipine/Lidocaine Ointment.

Compounding Services
Non-Sterile
Troches are an oral dosage form, where the medication
is absorbed through the vascularization of the mouth
(sublingual or buccal)
Hydrocodone
Testosterone

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Compounding Services
Non-Sterile
Suspensions/Solutions
Lidocaine 4% Spray
Lidocaine/Triamcinolone Swish/Spit or Swish/Swallow
Clotrimazole/Triamcinolone Suspensions
Stomatodynia/Burning Mouth Syndrome (usually contains
amitriptyline)

Compounding Services
Non-Sterile
Powders
Boric Acid/Hydrocodortisone/Cortisporin Otic Powders
Triamcinolone/Lidocaine Oral Bandages
Metronidazole Wound Powders

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Compounding Services
Non-Sterile
Lollipops
Nicotine
Prednisolone

Compounding Services
Address patients needs due to:
Side Effects
Intolerances/Allergies
Discontinued Medications
Not available any other way

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Compounding Services
Non-Sterile
Capsules; Gelatin or Vegtable cellulose body that will
hold medicinal powders or oils.
Progesterone
Levothyroxine/Liothyronine
Can make long acting
formulations
Can use excipients that are
hypoallergenic or free from

Compounding Services
Case #1
A man was referred to an ENT physician with ulcers throughout the
mouth and lips. The patient was unable to eat, drink or talk.
The prescriber contacted the compounding pharmacist and asked
for cost effective recommendations. The compounding pharmacist
recommended the Triamcinolone 0.1%/Lidocaine 4% Oral Bandage
dispensed in the puffalator for $35.00.
The compounding pharmacist followed up with the patients
girlfriend after 3 days. The ulcers were dramatically improved and
the patient was able to sip water and talk.
Approximately 2 months later the compounding pharmacist ran into
the prescriber. The prescriber stated that the ulcers were nearly
healed 1 week after using the medication.

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Compounding Services
Case #2
An elderly woman with a history of diabetic ulcers presented to a
wound clinic. The wound was near her ankle. The wound was
cultured and the bacteria was found to be sensitive to gentamicin and
metronidazole.
The prescriber was concerned that oral metronidazole would not be
sufficient due to the lack of circulation and that the patient would not
be able to tolerate the side effects.
Also, the wound care was very painful, so the prescriber would like to
have one topical product.
Compounded a gentamicin 0.2%/metronidazole 10% ointment to be
applied daily with dressing changes.
The wound slowly healed (approximately 6 months).

Regulations
The State Board of Pharmacy regulates the practice of
compounding.

The FDA regulates manufacturers.

If a pharmacy crosses the line and manufactures, the FDA

will have the right and responsibility to inspect the
pharmacy.

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Regulations
Compounding occurs when the doctor, patient,
(compounding) pharmacist triad is present. Compounding
does allow for anticipatory compounding. Some states do
allow for non-sterile office use compounding.

Manufacturing occurs when:

The triad is not present
The medication is commercially available

Regulations

What is the USP?

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Regulations
From the USP website, www.usp.org:

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit

organization that sets standards for the identity, strength, quality, and
purity of medicines, food ingredients, and dietary supplements
manufactured, distributed and consumed worldwide. USPs drug
standards are enforceable in the United States by the Food and Drug
Administration, and these standards are used in more than 140 countries.

Since its founding in 1820, USP has helped secure the quality of the
American drug supply. Building on that legacy, USP today works with
scientists, practitioners, and regulators of many nations to develop and
revise standards that help protect public health worldwide.

www.usp.org. Accessed [Date].

Regulations
The Boards of Pharmacy and the FDA look to the USP for
guidance on best practices and standards.

The USP has several chapters that address compounding

specifically.

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Regulations
From the USP Website http://www.usp.org/usp-healthcare-
professionals/compounding:
<795> Pharmaceutical Compounding Nonsterile
Preparations
<797> Pharmaceutical Compounding Sterile Preparations
<800> Hazardous Drugs Handling in Healthcare Setting
<1160> Pharmaceutical Calculations in Prescription
Compounding
<1163> Quality Assurance in Pharmaceutical Compounding
<1176> Prescription Balances and Volumetric Apparatus

USP <795>
The entire chapter can be found at
http://www.pharmacopeia.cn/v29240/usp29nf24s0_c795.h
tml

http://www.pharmacopeia.cn/v29240/usp29nf24s0_c795.html. Accessed: [DATE].

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USP <795>
COMPOUNDINGThe preparation, mixing, assembling,
altering, packing, and labeling of a drug, drug delivery
device or device in accordance with a licensed
practitioners prescription or medication order or initiative
based on the practitioner/patient/pharmacist/compounder
relationship in the course of professional practice.

http://www.pharmacopeia.cn/v29240/usp29nf24s0_c795.html. Accessed: [DATE].

USP <795>
Responsibilities of the Compounder:
1.Personnel are qualified.
2.Acceptable ingredients.
3.Finished product has what it says it has and at the strengths
indicated.
4.Processes are validated.
5.Compounding area is suitable.
6.BUD dates are accurate and valid
7.Assurance Processes
8.Processes are adequate to prevent errors.
9.Adequate procedures and records are available to identify and correct
any deficiencies in the compounding process

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The Compounding Pharmacy Tech
Roles of the Pharmacy Tech:
Compounding
Maintenance of Records
Formulating
Double check for the RPh

The Compounding Pharmacy Tech

Roles of the Pharmacy Tech:
Compounding
Accurate training is needed for each dosage form.
System to check the tech.
Organization and focus is imperative.
Reproducible results.

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The Compounding Pharmacy Tech
Roles of the Pharmacy Tech:
Maintenance of Records
Compounding Logs
Certificate of Analysis
Prescription Records

The Compounding Pharmacy Tech

Roles of the Pharmacy Tech:
Formulating
Assisting the pharmacist in the process of creating a new
formulation.

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The Compounding Pharmacy Tech
Roles of the Pharmacy Tech:
Double check for the RPh
All compounders should have a double check, regardless
of licensure.

Resources for Compounding Services

USP
www.usp.org/usp-healthcare-professionals/compounding

FDA
http://www.fda.gov/Drugs/GuidanceComplianceRegulatory
Information/PharmacyCompounding/default.htm

State Boards of Pharmacy

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Resources for Compounding Services
Associations/Memberships

International Academy of Compounding Pharmacists

www.iacprx.org

American College of Apothecaries http://acainfo.org

PCCA http://www.pccarx.com/

Medisca https://www.medisca.net

Resources for Compounding Services

Associations/Memberships continued

Letco www.letcomedical.com

Fagron www.us.fagron.com

PCCA, Medisca, Letco, and Fagron are also manufacturers

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Resources for Compounding Services
Miscellaneous Resources

Package insert from manufactured medications.

Certificate of Analysis

Internet

Lexicomp, Clinical Pharmacology, Facts and Comparisons

Equipment Needed
As determined by the State Board of Pharmacy
USP <795> states that the equipment must be of
appropriate design and size.
Ensure reproducibility regardless of who compounds.
Professional equipment
Automated equipment (Electronic Mortar & Pestle vs. Mortar &
Pestle.
Kitchen equipment

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Questions

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