9 Q2 2021 | Animal Health Solutions
The safety of a pharmacy's final compounded product
is the culmination of relevant rules and regulations, the
pharmacy's procedures and expertise, and teamwork with
veterinarians. Adverse events related to compounded
products from 503A facilities are voluntarily reported to
the FDA by pharmacists and veterinarians, although in
some states, it may be mandatory. 503B compounders
are required to report adverse events related to their
compounded products to the FDA.
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Where should veterinarians order
compounded medications and go for
more information?
In general, veterinarians should seek compounding
pharmacies that specialize in veterinary medicine,
as these pharmacies typically have more specialized
experience pertinent to veterinary customers. Several
additional resources are available within the full-length
version of this article at cliniciansbrief.com/article/
navigating-compounding-regulations-what-veterinary-
community-needs-know.
Compounding law is actively evolving; the more practicing
veterinarians know about this landscape, the more they
can be involved in shaping it. State veterinary medical
associations and SBOP can often help solicit veterinary
opinion and help make this heard. Proposed federal
guidelines also solicit feedback and input, which is
particularly important for the veterinary community to get
involved in, as there are so many unique situations in the
veterinary field that may not be considered without input
from veterinarians in practice.
For veterinary professionals, the oversight and
regulation of compounding is important not only for
legal reasons but for ethical ones as well. Compounded
drugs continue to be a valuable part of veterinary practice.
In part three of this series, the current quality standards of
veterinary compounding and how compliance is facilitated
will be discussed.
Disclaimer: This article was written by a clinical veterinary pharmacist.
The author is not a lawyer; therefore, this article should not be used as
legal advice.
Sources:
1. US Food & Drug Administration. Q&A: Draft GFI #256 - compounding animal drugs
from bulk drug substances. US FDA website. https://www.fda.gov/animal-veterinary/
animal-drug-compounding/qa-draft-gfi-256-compounding-animal-drugs-bulk-drug-
substances. Updated March 9, 2020. Accessed September 24, 2020.
2. US Food & Drug Administration. Animal drug compounding. FDA website. https://
www.fda.gov/animal-veterinary/unapproved-animal-drugs/animal-drug-compounding.
Updated January 8, 2020. Accessed March 12, 2021.
3. US Food & Drug Administration. Facts about the current good manufacturing
practices (CGMPs). https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-
about-current-good-manufacturing-practices-cgmps. US FDA website. Updated June
25, 2018. Accessed September 23, 2020.
4. National Association of Boards of Pharmacy. Model pharmacy act/rules. NABP
website. Accessed September 23, 2020.
5. United States Pharmacopeia. Recognition of USP compounding standards. USP
website. https://www.usp.org/compounding/legal-considerations. Accessed September
23, 2020.
6. The FDA Group. 503A vs. 503B: a quick-guide to compounding pharmacy
designations & regulations. FDA Group website. Published October 12, 2017. Accessed
September 23, 2020.
7. H.R.3204 - Drug Quality and Security Act. https://www.congress.gov/bill/113th-
congress/house-bill/3204. Accessed September 23, 2020.
8. US Food & Drug Administration. Questions and answers: outsourcing facility
registration. US FDA website. https://www.fda.gov/drugs/human-drug-compounding/
questions-and-answers-outsourcing-facility-registration. Accessed September 23,
2020.
9. US Food & Drug Administration. Information for outsourcing facilities. US FDA
website. https://www.fda.gov/drugs/human-drug-compounding/information-
outsourcing-facilities. Updated September 10, 2020. Accessed September 23, 2020.
10. US Food & Drug Administration. Q7 good manufacturing practice guidance for
active pharmaceutical ingredients: guidance for industry. US FDA website. https://www.
fda.gov/media/71518/download. Accessed September 23, 2020.
11. Accreditation Commission for Health Care. Compounding pharmacy accreditation.
ACHC website. https://www.achc.org/compounding-pharmacy.html. Accessed
September 23, 2020.
About the author Jennifer Kobylarczyk, PharmD, FSVHP, is a clinical consultant pharmacist at and the owner of Avant
Pharm Care in Lakewood, Colorado, as well as a compounding pharmacist at Wise Pharmacy. She earned her PharmD from University
of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. She is also a clinical veterinary pharmacist with Plumb's
Veterinary Drugs and has received her veterinary pharmacotherapy certification and PCCA compounding certificate.
