Implementation of GFI 263 will mean all medically important antimicrobials can only be administered by a veterinarian
The U.S. Food and Drug Administration (FDA) has finalized guidance for industry (GFI) 263, which outlines 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.
GFI 263 is an extension of GFI 213, under which 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 prescription marketing status and eliminate the use of these products for production purposes such as growth promotion.
With the implementation of GFI 213, approximately 96% of medically important antimicrobials used in animals are now under veterinary oversight. The remaining 4% of medically important antimicrobials 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.
During the two-year timeframe for implementation recommended in GFI 263, FDA plans to work with affected stakeholders and state partners to answer questions about the voluntary transition process and provide assistance where possible.