Over-the-counter antimicrobials changing to prescription-only

Woman holding bottle of pills

Understanding GFI 263

The basics of GFI 263

On June 10, 2021, the U.S. Food and Drug Administration (FDA) finalized guidance for industry #263 (GFI 263), which outlines the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over-the-counter (OTC) to prescription (Rx).

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 apply. All these medically important antibiotics will require a prescription from a veterinarian to be used.

The guidance provides a two-year implementation period. All OTC antimicrobial drugs will be prescription-only as of June 2023, and some products may change to Rx during the course of 2022. The FDA has developed a list of medically important antimicrobial drugs whose labels will change from OTC to Rx-only by June 2023. Examples of affected products include injectable penicillin and oxytetracycline.

Antibiotics must be used responsibly

The process outlined in GFI 263 is part of the FDA's broader effort to combat antimicrobial resistance, a serious threat to animal and public health. The increasing threat of antibiotic resistance (antimicrobial resistance) to both human and animal health compelled the FDA to take action. Antimicrobial use in humans, animals, and horticulture can contribute to the development of antimicrobial resistance.

Any antibiotic use can contribute to antibiotic resistance, so it's important to avoid unnecessary or inappropriate uses of antibiotics. 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 veterinarian's expertise is critical to ensuring the responsible use of antibiotics in animals.

Rx status protects animals and people

The FDA and drug manufacturers agreed to change the marketing status for antibiotics that are medically important from OTC to Rx, requiring veterinary oversight for their use. Under the direction of a veterinarian, the responsible and appropriate administration of antibiotics reduces the opportunity for resistance to develop and helps preserve our supply of effective antibiotics for situations when they are truly needed to protect animal and human health.

While the change maybe challenging, the end result will be more responsible antibiotic use benefiting both human and animal health.

Antibiotics will still be available

Veterinarians are committed to ensuring that animal health and welfare needs are met, and that needed medications are administered in a timely manner for treating, controlling, or preventing animal disease. Animals will still receive antibiotics when there is a clear indication that they are needed. Animal owners can work with veterinarians to ensure that animals have the care and medication they need, when they need it.