May 6, 2022

APC, CVM leaders meet, discuss GFI #256

On Wednesday, APC leaders met with officials from FDA’s Center for Veterinary Medicine to enunciate concerns about what APC sees as ambiguity and uncertainty in CVM’s final GFI #256, regarding animal compounding.

The hour-long virtual Q&A session was the result of an invitation from CVM’s Deputy Director of Science Policy Dr. Bill Flynn, who participated along with CVM’s Drs. Cindy Burnsteel and Amber McCoig.

Leaving aside any questions of FDA’s statutory authority for the regulatory framework GFI #256 imposes, APC Board Chair Michael Blair noted that the GFI goes well farther than restrictions placed on human compounding in DQSA.

Flynn replied that “the law does not lay out a clear pathway for compounding on the animal side” and that the agency has sought “to develop a framework that enables compounding for animal use, including from API.”

Much of the discussion in the meeting focused on the GFI’s restrictions on compounding for from bulk API. In addition, Also raised was the issue of how CVM’s “trust us” approach to enforcement discretion might not be shared by state boards of pharmacy, who may likely seek more restrictive enforcement in their state regulations and inspection regime.

Flynn indicated that the agency is aware of the concern and plans to “coordinate with state boards,” understanding there may be variations in enforcement.

“That response was not a particularly reassuring one,” said APC’s CEO Scott Brunner after the call.

The allocated hour was insufficient for covering APC’s extensive list of questions; the group agreed to schedule a follow-up meeting for later this month to take up, among other issues, concerns about adverse event reporting in the GFI. After that second meeting, APC will share publicly the document containing all our questions of CVM. APC will also be formally commenting on GFI #256 shortly.