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FDA finalizes guidance on over-the-counter antimicrobials for veterinary use

Ultimately, the US Food and Drug Administration’s (FDA) finalized guidance for industry GFI #263 is all about antimicrobial stewardship.

Released on June 10, GFI #263 from the FDA Center for Veterinary Medicine (CVM) outlines a two-year implementation period for animal drug manufacturers to voluntarily change the marketing status of some over-the-counter (OTC) antimicrobial drugs. The voluntary labeling changes mean that the relatively small number of medically important antimicrobial drugs that are currently available OTC would require a veterinarian’s prescription.  

Although most of the drugs affected by the new guidance are used in food-production settings, the FDA said that the guidance could impact companion-animal practitioners. The full list of affected drugs includes tablets, boluses, and oral solutions, but the majority are injectable products.

The FDA believes that veterinary oversight of these drugs will help lead to more judicious use of antimicrobials and slow the development of antimicrobial resistance (AMR). On their website, the FDA writes, “Antimicrobial drugs may not be necessary for proper treatment or a different antimicrobial may be a better tool. . . . Providing animals with the most appropriate antimicrobial is more likely to effectively resolve the infection and reduce the need for repeated or extended courses of antimicrobial therapy.”

Of the 94 affected drugs currently available OTC without a prescription, 76 are marketed for food-producing animals, FDA spokesperson Anne Norris told NEWStat: “[Only] 2 are all-dosage forms for companion animals, and 16 are all-dosage forms for both food-producing and companion animals.”

Ultimately, Norris said, the change in marketing status from OTC to prescription will require veterinarians “to be more involved when authorizing the use of medically important antimicrobials in animals.”

NEWStat asked J. Scott Weese, DVM, DVSc, DACVIM, how the new FDA guidance will affect companion-animal veterinarians. A contributing reviewer of the 2018 AAHA Infection Control, Prevention, and Biosecurity Guidelines, Weese has written about AMR on his Worms & Germs blog.

Weese said he doubted the new FDA guidance will have much of an impact. “In the past, companion-animal [AMR] issues largely related to pet-store purchases,” he said. In particular, purchases of antibiotics that were primarily marketed for fish, but which could also be used in treating dogs and cats. Essentially, it was mostly cases of pet owners trying to treat pets without a veterinarian’s help. “If there’s any impact, it would be a very marginal impact on owner-driven treatments, so that’s a good thing.”  

Weese also said companion-animal veterinarians shouldn’t have to worry about GFI #263: “There should be no impact on veterinarians in [companion-animal] practice since they would use, pretty much exclusively, prescription formulations.”

Weese’s final take on the new guidance: “[CVM GFI #263 is] closing the last remnants of what I’d consider low-hanging fruit from a regulatory standpoint. In developed countries, there’s no need for OTC drugs. They’re often misused and overused, and I’m not the only one who’s seen bad outcomes from people using OTC antibiotics in lieu of proper—and ultimately cheaper—veterinary care.”

“The bigger issue with OTC meds comes into play in low- and middle-income countries, where there may be poor access to veterinary—or human—healthcare.” In those cases, Weese said, “OTC sources become an important but still undesirable stopgap.”

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