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OTC Antimicrobials Changing to Prescription Only In June 2023

March 6, 2023

OTC Antimicrobials Changing to Prescription Only In June 2023

As of June 11, 2023, all medically important antibiotics approved for use in animals—both companion and food animal—will no longer be available over-the-counter (OTC). The drugs will also display the following statement on the label “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

Products available OTC are typically sold at farm and feed stores and by online suppliers. To obtain these drugs, producers will need a valid veterinarian-client-patient relationship (VCPR) with a licensed veterinarian. For producers, the VCPR does not mean that they must purchase the drugs from their veterinarian, but it does mean that the distribution of antibiotics will require a prescription from the veterinarian with whom they have a valid VCPR to purchase the drugs.

On June 10, 2021, the U.S. Food and Drug Administration (FDA) finalized guidance for industry #263 (GFI 263), which outlined a two-year process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from OTC to prescription (Rx). The FDA has developed a list of medically important antimicrobial drugs whose labels will change from OTC to Rx by June 2023. Examples of affected products include injectable penicillin and oxytetracycline.

Antibiotics must be used responsibly

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 used of antibiotics. GFA 263 puts responsibility for the use of medical 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 may be challenging, the end result will be more responsible antibiotic use benefitting both human and animal health.