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The U.S. Food and Drug Administration released draft guidance for industry (GFI) #263 to explain the recommended process for voluntarily bringing the remaining approved, medically important antimicrobial drugs under the oversight of licensed veterinarians by changing the approved marketing status from over-the-counter (OTC) to prescription (Rx).
This is part of the FDA’s Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings and builds upon the successful implementation of GFI #213 under which OTC medically important antimicrobials used in animal feed or drinking water were brought to veterinary feed directive/Rx marketing status. Additionally, GFI #213 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The FDA is proposing a two-year implementation period that would begin after the agency considers comments on the draft guidance and issues the final guidance. The FDA plans to engage with affected stakeholders and state partners at public events to hear feedback and answer questions about the changes proposed in the draft guidance document.
September 23, 2019 / FDA/ United States
https://www.fda.gov/
