The Food and Drug Administration, Center for Veterinary Medicine released draft guidance for industry #263 that outlines the process for voluntarily bringing the remaining approved medically-important antimicrobial drugs for human medicine that are being used in animals under the oversight of licensed veterinarians by changing the approved marketing status from over-the-counter to prescription only. This action is part of the agency’s Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings and is consistent with judicious use practices outlined in the National Action Plan to Combat Antibiotic Resistant Bacteria.
In addition, FDA is accepting public comments on draft GFI #263 until December 24, 2019. To submit comments, visit www.regulations.gov and search for Docket Number FDA-2019-D-3614. The complete draft GFI #263 can be found at https://www.fda.gov/media/130610/download.
