FDA to issue new guidance for animal drug compounding in 2018

Published on November 08, 2017

Protecting access to critical drugsIn May 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance for animal drug compounding. This week, the agency announced it is withdrawing this draft guidance and will issue new draft guidance in early 2018 for public comment. The AVMA looks forward to working with the FDA to ensure the new guidance preserves veterinary access to compounded preparations and serves the needs of veterinary patients.

Following the FDA’s issuance of draft guidance in 2015, the AVMA and our members provided significant feedback to help improve and shape the guidance. We’re grateful to our members and volunteers who provided this important feedback. As the FDA works on new draft guidance for 2018, the agency will be able to draw from our input to develop provisions that address veterinary concerns.

Following the release of the FDA’s new guidance in 2018, the AVMA will carefully review the new language and work closely with the FDA to ensure that it addresses the needs of veterinary patients. The AVMA is committed to preserving the FDA’s drug approval process while ensuring access to compounded preparations for the veterinary profession, including compounding from bulk drug substances. Because of the multitude of species and conditions that veterinarians treat, compounding will always be a vital tool for veterinarians.

The decision to withdraw its 2015 draft guidance will not have any impact on FDA’s current regulation of animal drug compounding. We will continue to provide updates on developments around this issue. To learn more about compounding, including the AVMA’s compounding policies and efforts, visit the compounding page of AVMA.org.