July 22, 2022
Associations request GFI 256 enforcement delay
In a joint letter to FDA Center for Veterinary Medicine Director Steven Solomon, five national pharmacy associations that represent veterinary compounding pharmacists requested that CVM delay enforcement of GFI 256 until fiscal year 2024, which begins in October 2023. GFI 256 asserts that FDA has regulatory oversight over animal compounding.
The associations include APC, the American College of Veterinary Pharmacists, the American Pharmacists Association, the National Community Pharmacists Association, and the Society of Veterinary Hospital Pharmacists.
“The ability of many of those pharmacists to serve animal patients will be affected by this GFI,” the associations stated in the letter, “And we believe there remain too many unanswered questions for pharmacy compounders to have clarity about what constitutes compliance – much less achieve that compliance – in such a short time.”
Read the letter here.