February 17, 2023

CVM responds to GFI 256 questions

FDA’s Center for Veterinary Medicine responded this week to a July 26, 2022, letter from APC and NCPA requesting answers to more than 30 technical questions about GFI 256 compliance. 

“There’s a good amount of helpful information in CVM’s response,” said APC Board Chair Anthony Grzib. “It appears the agency took seriously our concerns about clarity in the GFI and has made a good-faith effort to describe its view of compliance. We’re grateful to Dr. Bill Flynn and his CVM team for that.”

Among the highlights of CVM’s answers to the associations’ questions:

  • FDA does not intend to conduct inspections at 503B outsourcing facilities until it provides clarification on how GFI 256 applies to those facilities.
  • FDA does not expect compounding pharmacies to confirm a valid VCPR exists.
  • FDA will not question pharmacists’ professional judgment as to the documented reason a bulk ingredient was used instead of an FDA-approved drug. 
  • FDA does not expect compounders to retroactively obtain medical rationale for prescriptions written prior to April 1, 2023.
  • CVM does not have a program to share with state licensing boards individual adverse events reports the agency receives. 
  • FDA generally intends to refrain from taking enforcement action for bulk drug substances that are currently under review so that veterinary access to those compounded products is not restricted during the review process.

“APC’s next steps will be to share CVM’s responses with stakeholders, including state boards of pharmacy,” said Grzib. “We want to cement among regulators an understanding of what compliance looks like that is consistent with CVM’s. That can help assure more consistent enforcement across the country.”