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The U.S. Food and Drug Administration (FDA) finalized guidance for industry (GFI) #263 to outline the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over-the-counter (OTC) to prescription (Rx). Once this change is made, these important drugs can only be used in animals under the supervision of a licensed veterinarian.
GFI #263 is an extension of the successful implementation of GFI #213. Under GFI #213, animal drug sponsors worked with FDA to voluntarily change OTC medically important antimicrobials used in the feed or drinking water of food-producing animals to veterinary feed directive (VFD) or Rx marketing status and eliminate the use of these products for production purposes (e.g., growth promotion). With the successful implementation of GFI #213, approximately 96 percent of medically important antimicrobials used in animals are now under veterinary oversight.
The remaining four percent of medically important antimicrobials currently marketed as OTC products for food-producing and companion animals include other dosage forms, such as injectables and topicals. Once the recommendations in GFI #263 have been fully implemented, all dosage forms of medically important antimicrobials approved for use in animals could only be administered under the supervision of a licensed veterinarian, and only when necessary for the treatment, control or prevention of specific diseases. Although animal owners would still have access to medically important antimicrobials to address animal health issues, they would need to consult their veterinarian to obtain a prescription.
June 10, 2021/ FDA/ United States.
https://www.fda.gov/
