February 10, 2023

Phased-in GFI enforcement? Put it in writing, associations tell CVM

In a meeting last week with APC and NCPA reps, FDA Center for Veterinary Medicine’s Dr. Bill Flynn indicated that the agency’s stated April 1 date for commencing GFI 256 enforcement was not ironclad. 

Flynn indicated that the agency will begin phasing-in inspection activities on that date—on parts of the GFI for which compliance is reasonably clear—and that the agency anticipates a limited number of inspections for the remainder of FY2023. He added that those inspections that do occur will be “informational” in nature, with emphasis on the agency advising the inspected pharmacy/facility on observed areas of non-compliance.

APC and NCPA responded this week to that new info with a letter to Flynn urging that CVM publicly state its enforcement plans, and that it do so by February 28. Without such a statement, the associations indicated they intend to advocate for an additional formal delay of enforcement by the agency.

“We’re not opposed to phased enforcement, provided we know what that means and compounding pharmacies have time to come into compliance with areas in which compliance is not yet clear,” said APC Board Chair Anthony Grzib. “So we’re asking CVM to identify specific policies within the GFI that they feel are pretty clear and will likely begin enforcing on April 1, versus which policies they know they still have to figure out and can’t and won’t begin to enforce April 1. A public statement by CVM to that effect will also help state boards of pharmacy align their interpretation and enforcement roll-out with FDA’s.”