August 12, 2022
Carter, Harshbarger request GFI 256 enforcement delay
In a letter last week to FDA Center for Veterinary Medicine Director Dr. Steven Solomon, Congressman Buddy Carter (GA) and Congresswoman Diana Harshbarger (TN) respectfully requested that CVM and FDA delay enforcement of GFI #256 until at least FY2024, and continue to work with pharmacy and veterinarian stakeholders, including state regulatory agencies, to provide clarification as to how the guidance will be implemented and enforced.
The authors explained that the ability of many veterinarians and pharmacists to serve animal patients will be affected by this GFI, and there remain too many unanswered questions for pharmacy compounders and veterinarians to achieve compliance in such a short time.
Click here to read the full letter.