Based on feedback from member veterinarians and other stakeholders, the AVMA has compiled a list of key points to share with the FDA in our formal comments on the proposed FDA Draft Guidance for Industry #256: Compounding Animal Drugs from Bulk Substances.
The deadline for commenting on the draft guidance is October 15, 2020. The AVMA has been gathering input from members and others since the proposed guidance was released in November 2019.
AVMA’s formal comments to the FDA will include, among others, support for these provisions:
- Three sets of circumstances in which compounding from bulk drug substances (BDS) may be medically necessary: when the approved product is not commercially available, the needed compounded preparation cannot be made from the approved product, or when there is no approved product from which to compound the needed preparation
- The requirement that a veterinarian-client-patient relationship (VCPR) as defined by FDA must exist for use of a compounded drug in an animal patient
- For food-producing animals, the creation of a publicly available, current list of bulk drug substances that can be used to compound animal drugs, when a valid VCPR exists, and that is limited to drugs used for euthanasia, depopulation, or as poison antidotes
- Veterinarians’ ability to maintain sufficient quantities of compounded preparations in their office for urgent administration or dispensing in emergency situations
- Compounding must be performed under the direct supervision of a veterinarian or pharmacist
- Provisions that address concerns regarding specific compounded preparations, such as those that are “copies” of FDA-approved products
- Compounding according to United States Pharmacopeia (USP) and National Formulary (USP-NF) guidance—however, as USP provisions are not always relevant, appropriate, or applicable to veterinarians or pharmacists compounding medications for animal patients, the AVMA is working closely with the USP to create a veterinary-specific compounding chapter and ability to extend beyond-use dates (BUD)
- Specific prescription dispensing and labeling requirements
- Further collaboration with veterinarians and pharmacists on developing and strengthening the adverse event reporting system
AVMA’s comments will express concern regarding these provisions:
- Requirement that a veterinarian include the medical rationale on the prescription for the compounded drug
- For non-food-producing animals, a list to determine the appropriateness of compounding from bulk drug substances for office stock drugs—the AVMA does not believe creating a “positive” list, as currently conceived, is practicable due to, among other things, the supporting information that FDA requires for all of the bulk drug substances needed to prepare office stock for all the urgent needs of nonfood-producing animals, including minor species
Learn more about the draft guidance
A free webinar on AVMA Axon, Compounding: Understanding FDA draft guidance, shares more information about the draft guidance, including:
- Why the FDA can’t assure the safety, effectiveness, or quality of bulk drug substances
- How the draft guidance attempts to balance the risks of animal drugs compounded from bulk drug substances with animal health needs when no FDA-approved drug is available
- Policies included in the draft guidance and how they impact veterinary practice
The webinar gives important background to help veterinarians provide informed feedback on the proposed guidance. AVMA also has prepared a summary of the proposal’s key points. If you would like to submit your own feedback to the FDA, public comments on draft GFI #256 will be accepted until the October 15, 2020, deadline. To submit comments electronically, visit www.regulations.gov and type FDA-2018-D-4533 in the search box.
Explore AVMA compounding resources
AVMA provides numerous resources to help veterinarians navigate the fine points of prescribing and using compounded medications. Visit avma.org/Compounding for definitions, answers to frequently asked questions, AVMA policies on compounding, and other tools.