The Food and Drug Administration (FDA) has finalized guidance for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over the counter (OTC) to prescription.
Once the change is made, the drugs may only be used in animals under the supervision of a vet. This change is an extension of the rule for OTC medically important antimicrobials used in feed or drinking water to be changed to veterinary feed directive (VFD) status. This eliminated the use of the products for production purposes, such as growth promotion.
Now, about 96 percent of medically important antimicrobials are under veterinary oversight. Under the new guidance, the remaining 4 percent of medically important antimicrobials marketed as OTC products can only be administered by a vet and only when necessary.
“Although animal owners would still have access to medically important antimicrobials to address animal health issues, they would need to consult their veterinarian to obtain a prescription,” FDA said. There will be a two-year implementation process for the new guidance.
