GFI #256: The Ever-Changing Guidance Town Hall – May 18, 2023
On Thursday, May 18, 2023, ACVP presented a virtual Town Hall meeting on GFI #256, who it affects, and how to comply.
After a short PowerPoint presentation by Brenda Jensen, CPhT, CNMT, MBA, Gigi Davidson, BSPharm, DICVP, FACVP, FSVHP, moderated a panel discussion on the topic.
Panelists:
- Brian Bowers, PharmD, FACVP
- Natalie Young, PharmD, BCSCP, FACVP
- Rob Hunter, MS, PhD, CEO of One Medicine Consulting
- Matt Martin, PharmD, BCSCP
- Brenda Jensen, CPhT, CNMT, MBA
Recordings:
- To watch the video recording: Click here to view
- To listen to the audio recording: Click here to listen
Important Links and Resources:
- GFI 256: https://www.fda.gov/media/132567/download
- Animal drug shortages can be reported to: AnimalDrugShortages@fda.hhs.gov
- List of APIs for office stock for NON food producing animals: https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-office-stock-drugs-use-nonfood-producing-animals
- List of APIs under review: https://www.fda.gov/animal-veterinary/animal-drug-compounding/bulk-drug-substances-currently-under-review
“While these evaluations are being completed, the agency generally intends to refrain from taking enforcement action when these bulk drug substances are used to compound a finished drug in a state-licensed pharmacy or federal facility or by a state-licensed veterinarian as described in the initial nomination.” - Veterinary Adverse Drug Reaction Online Reporting Form (1932a)
- GFI 256 Town Hall Presentation Slides
