August 2, 2022
APC, NCPA ask CVM for GFI 256 clarity
A joint APC-NCPA letter submitted last week to the FDA Center for Veterinary Medicine’s Dr. Bill Flynn includes more than two dozen questions on which the associations seek great clarity regarding the agency’s animal compounding GFI.
“We believe your answers can provide much-needed clarity on how the agency views the processes enumerated in the guidance document and can help compounding pharmacists, veterinarians, and state boards of pharmacy better understand how the agency will view compliance with the GFI,” the letter states. “We also believe that the questions contained in this letter demonstrate the range and depth of what is as yet unknown about the effect and enforcement of the GFI, and therefore support the recent joint letter submitted by several pharmacy trade associations requesting an enforcement delay on the GFI until at least FY2024.”
APC intends to communicate Flynn’s responses to our members and other stakeholders so that they can build processes and SOPs to attain compliance with GFI 256.