Beginning in June of 2023, livestock owners will need a prescription from a licensed veterinarian to purchase all medically important antimicrobial drugs, says Dr. Gerald Stokka, North Dakota State University Extension veterinarian and livestock stewardship specialist. Currently, there are several antibiotics sold over-the-counter (OTC) that do not require a veterinary prescription to purchase. 

The changes being implemented in 2023 are the latest in a plan put into place in 2012 by the Food and Drug Administration. At that time, the FDA recommended limiting the use of antimicrobial drugs that are considered necessary for assuring animal health to include veterinary oversight or consultation.

Following this guidance, in 2013, recommendations regarding the transition of medically important antimicrobials administered through feed and water required either a veterinary feed directive (VFD) or a prescription status. This guidance resulted in the use of these products now being authorized by a veterinarian within a veterinary client patient relationship (VCPR). The new labels implementing this policy went into effect in January 2017.

The most recent guidance document pertains to transitioning the sale and use of the remaining medically important, OTC antimicrobials to prescription status. Once the recommendations have been fully implemented, all dosage forms of medically important antimicrobials approved for use in animals can only be administered under a prescription from a licensed veterinarian with a VCPR and only when necessary for the treatment, control or prevention of specific diseases.

The most common products in this category include penicillin (both procaine and procaine/benzathine formulations), all oxytetracycline products including 100, 200 and 300 mg/ml injectable formulations, and the sulfa class of antimicrobials. A list of all products changing to prescription status can be found at https://www.fda.gov/animal-veterinary/antimicrobial-resistance/list-approved-new-animal-drug-applications-affected-gfi-263.

“Antimicrobials for use in livestock can be purchased from a veterinary clinic or from a registered animal health retail facility,” says Dr. Stokka. “The veterinarian with which your operation has a VCPR will need to provide a prescription to the retail operation to allow for the purchase.

“This VCPR implies a relationship with the operation, knowledge of the operation and knowledge of the animals’ need for antimicrobial treatment,” adds Dr. Stokka.

The retailer, if not already registered with the state of North Dakota as an animal health retail facility, will need to apply through the North Dakota Board of Pharmacy. In addition, one person associated with the facility must be registered as a veterinary dispensing technician to assure documentation and proper product labeling.

After June 11, all new product entering distribution channels that was formerly purchased OTC, must be labeled as prescription products. However, the FDA intends to allow existing inventory of OTC-labeled product that may already be in distribution channels to deplete.

New inventory with changes that reflect the change from OTC status will be labeled with new labels indicating prescription status. The wording is as follows, “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”  This statement must appear on the container label.

Animal owners still have access to medically important antimicrobials to address animal health issues in consultation with their veterinarian to obtain a prescription. Drug sponsors, which means drug manufacturers, have two years to voluntarily comply with the guidance. This voluntary compliance began in June of 2021.

“The livestock industry continues to respond to changes regarding the use of antimicrobials,” says Dr. Stokka. “We have adopted the concept of judicious use as part of our commitment to antimicrobial stewardship, and the careful and responsible management of antimicrobial resources. The principles are simple: use only when necessary, and use under the direction of a veterinarian with a valid VCPR.”

NDSU Agriculture Communication – March 7, 2023

Source: Gerald Stokka, 701-231-5082, Gerald.stokka@ndsu.edu

Editor: Kelli Anderson, 701-231-6136, kelli.c.anderson@ndsu.edu