September 12, 2022

WE DID IT! FDA grants our request for an enforcement delay on GFI 256

In July, APC led several pharmacy organizations in sending a joint letter asking FDA Center for Veterinary Medicine’s Dr. Steven Solomon for additional clarity regarding the agency’s animal compounding GFI. Citing the inability of pharmacies and veterinarians to comply by the stated October 1, 2022, enforcement start date, the letter also requested an extension on the enforcement delay of GFI 256 until at least FY2024.

On Friday, September 9, APC received the agency’s response, which acknowledged the joint request for clarification and—most importantly—granted us a six-month extension (April 2023) on the enforcement delay. 

ACP CEO Scott Brunner commented, “We’re grateful to CVM for its responsiveness to our request for an enforcement delay. We believe the delay is as essential to CVM as it is to compounding pharmacies and veterinarians as we all try to figure exactly what compliance with the new GFI looks like.”

Brunner added that APC will continue to work with CVM to get the sort of clarity that can allow our members to create SOPs and bring their practices into compliance by the new April 2023 deadline.

There’s no end to what we can accomplish when we mobilize the voices and opinions of our members and our sister pharmacy associations, and channel them towards achieving our goals and furthering our collective missions.

NOTE: APC recently hosted a virtual briefing on GFI 265. For those who couldn’t attend, you can watch the recording here.