FDA
has released draft guidance for industry (GFI) #263 to explain the recommended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).
These
changes took effect in January 2017. A limited number of other dosage forms of
medically important antimicrobials, such as injectables, are currently marketed
as OTC products for both food-producing and companion animals. When Draft GFI
#263 has been finalized and fully implemented, all dosage forms of all approved
medically important antimicrobials for all animal species can only be
administered under the supervision of a licensed veterinarian and only when
necessary for the treatment, control or prevention of specific diseases.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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