January 24, 2022

The latest on animal compounding and GFI #256

Wedgewood Pharmacy and a coalition of groups including APC and PCCA helped shepherd a letter to FDA Acting Commissioner Janet Woodcock from eight members of Congress. They expressed their concerns with GFI #256, “Compounding Animal Drugs from Bulk Drug Substances,” pointing out that there have not been significant stakeholder meetings in the year since GFI #256’s comment period ended.

“GFI #256 presents too significant of a barrier in access to medications for pets, companions, and exotic animals for the agency to move forward with final guidance at this time,” they wrote. “Therefore, it is necessary for the FDA to issue another round of draft guidance to ensure there is fair evaluation of any new proposal or changes.”