June 10, 2021
Today, the U.S. Food and Drug Administration 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.
Veterinarians have specialized scientific and clinical training and practical experience that can help guide the judicious use of antimicrobials. FDA believes good antimicrobial stewardship practices in animals helps slow the development of antimicrobial resistance and preserve the effectiveness of these drugs in both humans and animals.
The agency is committed to working with affected stakeholders to facilitate the transition process and to minimize impacts on animal health. 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.
- Guidance for Industry #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
- Federal Register, Notice of Availability: 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; Guidance for Industry
- GFI #263: Frequently Asked Questions for Farmers and Ranchers
- List of Approved New Animal Drug Applications Affected by GFI #263
- Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023
- Antimicrobial Resistance Information from CVM
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.