Tuesday, 10 December 2019

Bringing remaining Over-The-Counter medically important antimicrobial drugs under veterinary oversight

The U.S. Food and Drug Administration released draft guidance for industry (GFI) #263 to explain the recommended process for voluntarily bringing remaining approved animal drugs containing antimicrobials of human medical importance (i.e., medically important) 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 momentum generated by the successful implementation of GFI #213. Under GFI #213, animal drug sponsors worked in collaboration with FDA over a 3-year period to voluntarily change OTC medically important antimicrobials used in the feed or drinking water of food-producing animals to VFD/Rx marketing status and eliminated the use of these products for production purposes (e.g., growth promotion).

See: https://www.fda.gov/animal-veterinary/cvm-updates/fda-releases-draft-guidance-bringing-remaining-approved-over-counter-medically-important

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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