May 20, 2022

Medically Important Antibiotics for Switching from OTC to Rx

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

Last June, the US Food and Drug Administration finalized tips for industry #263 (GFI 263) to describe 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 penicillin injection and oxytetracycline. Although the guidelines provide for a two-year implementation period, some products may transition 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 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 could purchase these drugs on sale. free at their local farm shop. Some small animal veterinary clinics might even want to actively seek out these clients and potential customers.

Antibiotics should 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 use of antibiotics can contribute to antibiotic resistanceit is important to avoid unnecessary or inappropriate use of these drugs.

GFI 263 places the responsibility for the use of medically important antimicrobials in the hands of veterinarians, who are trained to understand not only when these drugs are needed, but also what the drug is, the dose, for how long, and the method of administration. appropriate administration to resolve the infection and protect animal health and our food supply. Veterinary expertise is essential to ensure the responsible use of antibiotics in animals.

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