April 13, 2022

FDA releases final animal compounding GFI

FDA today released the final version of its Guidance for Industry #256 on animal drug compounding. APC is reviewing the document; you can read the 22-page PDF here.

Our preliminary take is that the Center for Veterinary Medicine appears to have accepted at least some of the changes we recommended during our meetings with it over the past year.

“We appreciate that the CVM took the time to hear our concerns and to address some of them in the final GFI,” said APC President Dave Miller, managing owner of Keystone Pharmacy, Grand Rapids, MI. “We understand the need to balance animal health and safety with the availability of essential compounded meds to veterinarians. However, from our initial reading of today’s release, we believe some of our most substantive concerns remain unaddressed in the GFI, and we look forward to discussing those with CVM.”

In terms of enforcement, we’ve been told that the agency intends to inject some “breathing room” of at least a few months between the GFI’s release today and commencing enforcement. FDA says it will be engaging stakeholders during that time both to detail how it expects the policy to work and to receive feedback. The agency has already invited APC leaders to sit down with the CVM team soon.

APC will provide more information on GFI #256 after we’ve had time to analyze it. Keep an eye on your inbox and APC’s Compounding Connections e-newsletter