IndustryNews

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.”

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