FDA Announces Transition of Over-the-Counter Medically Important Antimicrobials for Animals to Prescription Status
June 12, 2023
The U.S. Food and Drug Administration is announcing the successful implementation of guidance for industry (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.” GFI #263 was introduced in draft in 2019 and the final guidance published in June 2021 and outlined a two-year timeline for animal drug sponsors to transition products to prescription status.
FDA is pleased to share that all affected animal drug sponsors opted to either voluntarily change the approved marketing status of certain medically important antimicrobial drugs for animals from over-the-counter (OTC) to prescription (Rx) or to voluntarily withdraw approval of their affected OTC animal drug applications. As a result, all products affected by GFI #263 that enter the marketplace will now have prescription labels.
Once remaining inventory of OTC-labeled products depletes, all medically important antimicrobials for animals will require the authorization of a licensed veterinarian. FDA believes that given their specialized training and experience, veterinarians play a critical role in antimicrobial stewardship and can help reduce the risks of antimicrobial resistance.
Animal owners and caretakers will still have access to appropriate antimicrobials to address animal health issues by consulting with a licensed veterinarian. Specific requirements related to prescription animal drugs vary by state, including those related to the establishment of a valid veterinarian-client-patient relationship (VCPR). This highlights the importance of animal owners and caretakers consulting with their veterinarian to create a plan to help ensure they have access to appropriate antimicrobial products to address animal health issues when the need arises.
The successful implementation of GFI #263 is an encouraging demonstration of the commitment of animal drug sponsors and veterinarians to support the judicious use of antimicrobials in animals.
Additional Resources
- Guidance for industry (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
- GFI #263: Frequently Asked Questions for Farmers and Ranchers
- List of Approved New Animal Drug Applications Affected by GFI #263
- Antibiotic Stewardship in Beef and Dairy Cattle - Español
- Antibiotic Stewardship in Poultry - Español
- Antibiotic Stewardship in Sheep and Goats - Español
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.