AVMA has shared the profession’s needs with the FDA throughout the development of the guidance. The final guidance includes many changes made in response to concerns expressed by the AVMA and provides veterinarians considerable latitude when compounding in a practice setting, as well as when writing patient-specific prescriptions.
However, for a pharmacy to provide compounds prepared from bulk drug substances for office stock or dispensing, the compound must be on one of three lists to be maintained by FDA: the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals, the List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species, or the List of Bulk Drug Substances Currently Under Review.
AVMA voiced considerable opposition to the use of such lists, because of concerns about the feasibility of maintaining them to keep up with clinical demands. In response to our concerns, FDA modified their approach to make the process of creating and reviewing the lists more dynamic and has indicated they will work with the profession to ensure the lists are robust and comprehensive. Further, FDA has expressed its intent to focus on education and stakeholder engagement before shifting resources toward inspectional activities in the Fiscal Year 2023 (October 2022).
AVMA will continue to actively engage with FDA, and evaluate other options as necessary, to make sure veterinarians have medically appropriate access to drugs compounded from bulk drug substances and that such access is not unduly burdensome.
As a veterinarian, you play a critical role by letting AVMA know your thoughts on the final FDA guidance and by identifying bulk drug substances that you believe should be available for compounding for office stock and dispensing.
Contact AVMA at [email protected].
- FDA Guidance for Industry #256: Compounding Animal Drugs from Bulk Drug Substances
- FDA Tools (includes webinar, informational handouts, and graphics)
- Infographic: Compounding Animal Drugs for Nonfood-Producing Animals from Bulk Drug Substances
- FDA Q&A
Posted April 15, 2022