The AVMA has submitted comments to the FDA on the agency’s proposed guidance on compounding from bulk substances, and a new AVMA website resource answers commonly asked questions about the guidance.
AVMA’s formal comments on Draft Guidance for Industry #256: Compounding Animal Drugs from Bulk Substances were sent on October 8, 2020, and are based on input from AVMA members, volunteers, state and allied veterinary groups, and other stakeholders.
They cite provisions that AVMA supports in the draft guidance, as well as some areas of concern.
Provisions AVMA supports
- Three 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 there is no approved product from which to compound the needed preparation
- Requirements that a veterinarian-client-patient relationship (VCPR) must exist for use of a compounded drug in an animal patient, and that compounding must be done under the direct supervision of a veterinarian or pharmacist
- For food-producing animals, the creation of a publicly available, current list of bulk drug substances that can be used to compound animal drugs, which 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 emergencies
- Provisions addressing concerns about 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 aren’t always relevant, appropriate, or applicable to veterinarians or pharmacists compounding medications for animal patients, the AVMA is working closely with USP to create a veterinary-specific compounding chapter and ability to extend beyond-use dates (BUD)
- Specific requirements for prescription dispensing and labeling
- Further collaboration with veterinarians and pharmacists to develop and strengthen the adverse event reporting system
Provisions of concern to AVMA
- 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—AVMA doesn’t believe creating a “positive” list, as currently conceived, is practicable due to, among other things, the supporting information FDA requires for all of the bulk drug substances needed to prepare office stock for all urgent needs of non-food-producing animals, including minor species
AVMA anticipates continued dialog with the FDA as the agency works to finalize its guidance. We’ll keep you updated here on the AVMA blog.
New FAQ resource answers questions about the guidance
A new AVMA resource provides answers to some of the most commonly asked questions about GFI #256. These include the purpose of the draft guidance, what it contains, and what effect it could have on veterinarians’ access to medications compounded from bulk drug substances. You’ll find the FAQ at avma.org/Compounding, along with other materials to help veterinarians navigate the fine points of prescribing and using compounded medications.
A free webinar on AVMA Axon also outlines the key provisions of the FDA draft guidance and the policies affecting veterinarians and veterinary teams.