APC to FDA: Let’s rethink GFI #256

APC has formally submitted a comment to the FDA about GFI #256’s requirements for collecting information. We took the opportunity to remind the agency that GFI #256 should simply not be implemented in its current form at all, but more specifically we responded to questions about GFI #256’s information-collection requirements. We explained a few of our points of view, including...

• The agency doesn’t have the authority under current law to effectively [impose] a regulatory framework on veterinary compounding from bulk substances.
• The estimated burden of GFI #256’s requirements are higher than the agency thinks, as it relies on outdated data, and “The veterinary compounding landscape has evolved significantly in recent years due to factors such as increased pet ownership, consolidation of veterinary practices, greater reliance on compounded medications, and evolving regulatory requirements under USP chapters 795, 797, and 800.”
• The current bulk-drug nomination process needs to be streamlined — “Nearly 93% of nominations have been rejected to date, many without sufficient explanation.”
• “If FDA insists on retaining the current framework of GFI #256, it should accept a veterinarian’s prescription itself as sufficient documentation of medical need.”

In short, we continue to pressure the FDA to remove, reexamine, and recreate GFI #256 — this time with more input from veterinarians and compounders. APC likes to be ahead of the curve. We recommended this exact thing in our Blueprint, and we think this is the best way to protect animal patients.