News & Resources

FDA Releases Draft Guidance on Changing OTC Antimicrobial Status

November 13, 2019

The FDA released on September 23 draft Guidance for Industry #263 (GFI #263) “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter.”

FDA’s intent with GFI #263 is for animal drug pharmaceutical manufacturers to voluntarily change the marketing status of the remaining approved animal drugs containing antimicrobials of human medical importance from over-the-counter (OTC) to prescription (Rx) under the oversight of licensed veterinarians. This draft guidance comes as part of the FDA’s five-year plan for supporting antimicrobial stewardship in veterinary settings as part of a strategy to address antimicrobial resistance associated with the use of antimicrobial drugs in animal agriculture.

GFI #213 was the FDA’s first step to increase oversight of antimicrobial use through voluntary industry action to change marketing status of medically important antimicrobials used in feed or drinking water for food-producing animals from OTC to VFD/Rx. This also resulted in the elimination of the use of these antimicrobials for production practices. While GFI #263 will be voluntary, NMPF anticipates that pharmaceutical manufacturers will change the marketing status of the limited number of dosage forms of medically important antimicrobials that are still available from OTC to Rx for both food-producing and companion animals.

NMPF has recognized that OTC availability of antimicrobials was going away and has made the Veterinarian Client Patient Relationship, a cornerstone of the National Dairy FARM Animal Care Program. NMPF supports the prudent and responsible use of antibiotics and will be examining the potential impact on small or geographically isolated dairy farmers who may have a lack of large animal veterinary services where they are located.

NMPF will submit comments to the docket.