FDA issues draft guidance on compounding

Gloved hands grind powder with a mortar and pestle

Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) issued new draft guidance for animal drug compounding. AVMA is analyzing this guidance to understand how it would affect veterinary medicine, and we’ll work closely with FDA CVM to make any necessary improvements.

In May 2015, FDA CVM introduced draft guidance for animal drug compounding that did not meet the needs of veterinarians. Following significant feedback from the AVMA and the veterinary community, the agency formally withdrew that guidance in November 2017. Today’s guidance draws from this extensive veterinary feedback.

AVMA is undertaking a careful review of the new draft guidance with broad input from AVMA members as well as numerous species-focused, practice-focused, and state veterinary medical associations. The AVMA Council on Biologic and Therapeutic Agents and its Clinical Practitioners Advisory Committee will oversee this process.

Once this review is complete, AVMA will issue formal comments to the FDA CVM and work with the agency to ensure the new guidance serves the needs of veterinarians and our patients. AVMA is committed to preserving veterinary access to compounded preparations while also preserving the FDA’s drug approval process.

AVMA members who wish to provide feedback on the proposed guidance can email AVMA directly: compoundingatavma [dot] org.