Deadline for comments 12/24/2019:
The FDA has issued a draft guidance for industry (GFI) #263 entitled
“Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals..."
This draft guidance document, when finalized, will provide information to sponsors of medically important antimicrobial new animal drug products who are
interested in changing the approved marketing status of these products from over-the-counter (OTC) to by veterinary prescription (Rx) consistent with FDA's
recommendation that the use of such drugs in animals be limited to uses that include veterinary oversight to mitigate development of antimicrobial resistance.
It also will recommend timeframes for stakeholders wishing to comply voluntarily with this guidance.