April 7, 2023

APC sets record straight on “essential copies” in animal compounding

In a letter sent this week to FDA’s Center for Veterinary Medicine, APC corrected misleading input provided to the agency in a February comment letter from the Animal Health Institute and Generic Animal Drug Alliance.

The AHI and GADA asserted that compounding pharmacies are intentionally copying commercially available drugs and that the agency should immediately enforce GFI 256 to counter what they portrayed as illegal compounding of “essential copies.”

In its reply, APC sets the record straight, explaining that manufacturer shortages have long been the driving force behind compounding pharmacies filling demand for veterinary drugs. The letter urged CVM to continue working with compounding industry stakeholders to assure continued patient access in light of those ongoing shortages.