The message from our members has been loud and clear: compounding is a necessary practice because there are, and always will be, a limited number of U.S. Food and Drug Administration (FDA)-approved drug products for the many species and conditions that they treat. But right now, the FDA contends that compounding from bulk drug substances (i.e., active pharmaceutical ingredients) for animals has been and continues to be illegal. That said, the FDA recognizes the medical need for compounding from bulk ingredients, instead of using the FDA-approved drug product, within certain areas of veterinary practice and under very specific circumstances. The FDA’s GFI #230 (PDF) is a draft and therefore not the final word on compounding, and clearly we have to do more advocating for members’ compounding needs.While working on our other advocacy efforts at the state and federal level, we took the opportunity to help shape the FDA’s guidance document. Our letter (PDF) to the FDA was submitted on August 14, although the comment period has been extended until November 16. Thanks to our volunteers and members for guiding us on our comments! Here are some highlights:
• The use of compounded preparations is unquestionably necessary in species such as zoo animals, laboratory animals, exotic pets, wildlife, aquaria, and non-food aquacultural animals. We urge the FDA to carefully consider the critical need for access to compounded preparations within these species.
• The AVMA supports development of a user-friendly, easy-to-access form for reporting all adverse events related to compounded preparations, including lack of efficacy.
• There is a substantial need for both non-sterile and sterile compounded preparations to be maintained for office use in veterinary medicine.
• We believe the FDA should use the AVMA’s definition of “patient” which is an animal or group of animals examined or treated by a veterinarian. We have serious concerns with the verbiage “The drug is dispensed…for an individually identified animal patient…”
• Compounding from bulk drug substances in food-producing animals is medically necessary for certain poison antidotes, euthanasia, and depopulation medications. We ask the FDA to create a separate guidance for food-producing animals.
• We assert that compounding should be allowable if a change between the compounded preparation and FDA-approved drug product would produce a clinical difference, or if the approved drug product is not commercially available for other reasons (i.e., unavailable) and no therapeutic alternatives exist, or if the needed compounded preparation cannot be made from the approved drug product (such as preparation of metronidazole benzoate for use in a cat).
• We request that the FDA amend the document to allow a veterinarian to dispense a preparation compounded by a pharmacy or an outsourcing facility to the owner or caretaker of an animal under his or her care.
• We have reservations about the outline drafted in the guidance that would create a list for outsourcing facilities to use when compounding from bulk drug substances. If any such list is created, it needs to be maintained properly and updated to reflect the changing needs of veterinarians and their patients.
• Certain information should be incorporated into labels/packaging and all compounded preparations should be labeled that they are not FDA-approved drug products.
• The AVMA agrees with the requirement that any bulk drug substance used by either a pharmacy, veterinarian, or outsourcing facility is obtained from an FDA-registered manufacturer and accompanied by a valid certificate of analysis.
• A robust, nimble, current drug shortage list should be made publicly available and compounding in response to such shortages needs to be addressed by the FDA.
We continue our work to assess the feasibility of a bulk drug substance list, as the FDA seeks nominations of bulk drug substances for inclusion in Appendix A of GFI #230 through November 16. As always, we very much appreciate all feedback from our members so we can best advocate for your needs!