Compounding drugs is a critical tool for veterinarians, including compounding from bulk drug substances. While drugs compounded from bulk substances are considered to be unapproved, the Food and Drug Administration’s Center for Veterinary Medicine recognizes that veterinarians need these compounded drugs. On April 13, 2022, the agency published final guidance describing the conditions or situations under which the FDA does not intend to take enforcement action against entities compounding animal drugs from bulk drug substances. FDA has indicated that it will focus on education and stakeholder engagement before shifting resources toward inspection activities in October 2022.
The long-awaited final guidance establishes conditions under which veterinarians may use compounded drugs that are prepared from bulk drug substances. CVMA has worked closely with AVMA on this issue for several years. On behalf of Colorado veterinarians, in October 2020 CVMA sent comments to FDA on the proposed guidance. The final guidance includes many changes made in response to concerns expressed by AVMA, CVMA, and other veterinary medical associations.
AVMA has released extensive information about the new guidance from FDA on a dedicated AVMA webpage that includes information on: compounding for nonfood-producing species including both patient- specific and office stock compounding; compounding for food-producing species and free-ranging wildlife; and lists of bulk drug substances as well as the nomination process to add drugs to the lists.
CVMA will continue to work with AVMA on this important guidance.
