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NMPF Files Comments to FDA Over-the-Counter Antimicrobials Docket

January 7, 2020

NMPF filed comments to FDA’s draft guidance, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All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” on December 24, emphasizing the dairy industry’s commitment to prudent and responsible antibiotic use and general support for the guidance.

NMPF has recognized that the availability of over-the-counter (OTC) antimicrobials has decreased over the years and has made the Veterinarian Client Patient Relationship a cornerstone of the FARM Animal Care Program.

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 OTC to prescription (Rx) under the oversight of licensed veterinarians. This draft guidance comes as part of FDA’s five-year plan for supporting antimicrobial stewardship in veterinary settings as part of a strategy to address antimicrobial resistance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 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 still available from OTC to Rx for both food-producing and companion animals.

NMPF recognizes that there may be geographic and farm size challenges for some dairy farmers to have access to large-animal veterinarians. These concerns were outlined in our comments.