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FDA Draft Guidance Brings Remaining OTC Medically Important Antimicrobials for Animals Under Veterinary Oversight

The Food and Drug Administration released a draft guidance for industry outlining the process for changing the approved marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobials that are medically important for humans and used in animals. Guidance #263 will build upon GFI #213. 

The Food and Drug Administration released a draft guidance for industry outlining the process for changing the approved marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobials that are medically important for humans and used in animals.

 

The 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,” explains the recommended process for voluntarily bringing the few remaining approved animal drugs containing antimicrobials of human medical importance, such as injectables, under the oversight of licensed veterinarians.

 

This guidance is part of the FDA's Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings and builds upon GFI #213, which outlined the process for animal drug sponsors to work collaboratively with the FDA to voluntarily change OTC medically important antimicrobials used in the feed or drinking water of food-producing animals to Veterinary Feed Directive (VFD)/Rx marketing status and eliminated the use of these products for production purposes (e.g., growth promotion). These changes took effect in January 2017.

 

The FDA is proposing a two-year implementation period for the marketing status changes outlined in GFI #263. The agency intends to reach out to affected stakeholders and state partners to answer questions about the recommended process for voluntarily making these marketing status changes.

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