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Food and Drug Administration released draft guidance for industry (GFI) #263 to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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