Information on FDA Guidance Ending Over-the-Counter Antibiotics

Over-the-Counter Antibiotics will require Veterinary Oversight (Rx) beginning in June 2023 – Start Planning Now!

In June of 2021, the U.S. Food and Drug Administration (FDA) has announced that all medically important antimicrobials will move from over-the-counter (OTC) to prescription (Rx) only as of June 2023. The Center for Veterinary Medicine guidance for industry #263 (GFI 263) outlines the process.

This means that the injectable, oral, intramammary, and topical forms of antibiotics will require a prescription from a licensed veterinarian.

What species are included?

This applies to all companion and farm animal species.

When do these new changes become effective?

Beginning in June of 2023, or sooner, depending on when the manufacturer changes their labeling.

What do this mean to you and your livestock operation?

By June of 2023, all medically important antibiotics currently available at most feed or farm supply stores will now require veterinary oversight (written Rx) to be used in animals, even if the animals are not intended for food production.

Examples of affected antibiotics include injectable penicillin and oxytetracycline.

In addition, some retail suppliers who were able to sell these drugs/products in the past may no longer sell them after June of 2023.

This means in order to continue using medically important antimicrobials, you will need to establish a veterinary-client-patient relationship (VCPR). Consult your veterinarian for more information.

What is a veterinarian-client-patient-relationship?

veterinarian-client-patient-relationship (VCPR) is defined by the American Veterinary Medical Association as the basis for interaction among veterinarians, their clients, and their patients and is critical to the health of your animal(s). The practical explanation is that it is a formal relationship that you have with a veterinarian who serves as your primary contact for all veterinary services and is familiar with you, your livestock/animals, and your farm operation. This veterinarian is referred to as your Veterinarian of Record (VoR), and both the VoR and the client should sign a form to document this relationship.

AASRP Establishing and Maintaining the VCPR in a Small Ruminant Practice

Antibiotic Stewardship

Responsible stewardship practices include actions that preserve the effectiveness of antibiotics while maintaining animal health. This includes:

  • Only using antibiotics when necessary to manage illness in animals.
  • Establishing best management practices, like use of vaccines, and disease prevention plans to reduce the overall need for antibiotics.
  • Livestock owners and veterinarians working together to make decisions that improve animal health and welfare long-term.