Guide on Moving Animal Antimicrobials to Rx-only

FDA has posted a draft Guidance for Industry (GFI) #263, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under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,” to help explain the recommended process for voluntarily changing the approved marketing status of approved animal-use antimicrobials from over-the-counter to prescription-only. The document is part of FDA's Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings and is intended to build on the momentum generated by the successful implementation of GFI #213. The agency is proposing a two-year implementation period, and it intends to reach out to affected stakeholders and state partners to answer questions about the recommended process for voluntarily making these marketing status changes.