In a letter to the Alliance for Pharmacy Compounding, the Center for Veterinary Medicine at FDA has agreed to delay the enforcement of animal compounding GFI 256, “Compounding Animal Drugs from Bulk Drug Substances – Guidance for Industry” to April 2023. Enforcement had originally been slated to start on Oct. 1, 2022. NCPA and the APC had sent a joint letter to the CVM FDA regarding our ongoing concerns and additional questions we had with the framework and implementation of the GFI, in addition to a request to delay the GFI. This is in follow up to a previous, shorter letter by NPCA, APC, the American College of Veterinary Pharmacists, the American Pharmacists Association, and the Society of Veterinary Hospital Pharmacists asking FDA to postpone any enforcement of the GFI. APC will continue to work with CVM to get clarity on the GFI that can allow our members to create SOPs and bring their practices into compliance by the new April 2023 deadline.
NCPA
