End of OTC sale of medically important antibiotics for use in livestock

Beginning this week, livestock owners will need a prescription from a veterinarian before they can buy medically important antibiotics for use on their animals, announced the Food and Drug Administration on Monday. The new restriction is part of a multiyear campaign to preserve the efficacy of the antimicrobials in treating disease in humans.

The FDA said drug companies either voluntarily changed the marketing status of the affected medicines to prescription-only or withdrew them from over-the-counter sale during a two-year transition period. “As a result, all products affected by GFI (Guidance for Industry) No. 263 that enter the marketplace will now have prescription labels,” said the FDA.

GFI No. 263, issued in June 2021, affected 4 percent of sales of medically important antibiotics for use in food-bearing animals and companion animals. It was preceded by GFI No 213, which took effect in 2017 and ended the use of medically important antibiotics to help cattle, hogs and poultry gain weight. The drugs remain available for disease prevention and treatment of livestock under veterinary supervision. The FDA said 96 percent of medically important antibiotics sold for use in animals are covered by GFI No. 213.

“Farmers and ranchers would still have access to appropriate antimicrobials to address animal health issues by consulting with a licensed veterinarian with whom they have established a valid veterinarian-client-patient relationship,” said the FDA.

An FDA “frequently asked questions” about GFI No. 263 is available here.

The FDA list of antibiotics affected by GFI No. 263 is available here.