Medically important antibiotics to move from OTC to Rx

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Woman holding bottle of pills

By June 2023, all medically important antibiotics will require veterinary oversight to be used in animals, even if the animals are not intended for food production.

Last June, the U.S. Food and Drug Administration finalized guidance for industry #263 (GFI 263) to outline the process for animal drug sponsors to change the approved marketing status of certain antimicrobial drugs from over-the-counter (OTC) to prescription (Rx).

Examples of affected products include injectable penicillin and oxytetracycline. Though the guidance provides for a two-year implementation period, some products may change to Rx in 2022.

Once this change is made, these important drugs can only be used in animals under the supervision of a licensed veterinarian, even if the animals are not intended for food production. From pet dogs and cats to backyard poultry, and from pet rabbits and pigs to large livestock farms, the same restrictions will apply. 

This means that small animal veterinarians should be prepared for an increase in calls and visits from owners of small ruminants, pet pigs, backyard chickens, and other animals, who previously may have purchased these drugs over the counter at their local farm store. Some small animal veterinary clinics might even want to seek out these clients and potential clients actively.

Antibiotics must be used responsibly

The FDA is implementing GFI 263 as part of its broader effort to combat antimicrobial resistance, a serious threat to animal and public health. Because any antibiotic use can contribute to antibiotic resistance, it’s important to avoid unnecessary or inappropriate use of these drugs.

GFI 263 puts responsibility for the use of medically important antimicrobials into the hands of veterinarians, who are trained to understand not only when these medications are needed, but also what is the appropriate drug, dose, duration, and administration method to resolve infection and protect animal health and our food supply. The expertise of the veterinarian is critical to ensuring the responsible use of antibiotics in animals.

GFI 263 protects the effectiveness of antimicrobials in people and animals while still ensuring these drugs are available when needed. Learn more about antimicrobial use and resistance at



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