Beginning June 11, 2023, medically important antibiotics that are currently available over the counter (OTC) will require a veterinarian’s prescription. This guidance is part of a broader effort to reduce antimicrobial resistance (AMR) and follows the Veterinary Feed Directive that took effect in 2017. Following this change, the affected antibiotics will no longer be available OTC. This change impacts antibiotics used for both companion and food-producing animals. The FDA has issued this guidance to promote judicious use of antimicrobials and ensure the proper treatment is administered to prevent unnecessary or ineffective treatments and reduce the risk of AMR. To issue a prescription, the farm must have a valid Veterinary-Client-Patient Relationship (VCPR) in place. In New Hampshire, this requires:
- The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the patient and the client has agreed to follow the veterinarians' instructions.
- The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s), or by medically appropriate and timely visits to the premises where the animal(s) are kept.
- The veterinarian is readily available for follow-up evaluation or has arranged for the following: veterinary emergency coverage, and continuing care and treatment.
Although the affected antibiotics must transition to prescription status by June 11, there is an expected transition period. Any OTC labeled products already in distribution may remain and be purchased over the counter until the supply is depleted. However, no new OTC antibiotics may enter the supply chain. For producers, this means the supply on the shelf will dwindle and not be restocked. Additionally, antibiotics that have already switched to a prescription label cannot be sold over the counter and will require a veterinarian’s prescription. This guidance will impact injectable penicillin, tetracyclines, and mastitis and dry off intramammary treatments. Producers do not need to purchase the affected antibiotics through their veterinarian. If the producer has a valid prescription issued by a licensed veterinarian, they will be able to purchase through other suppliers. See the resources below for a more complete list of affected drugs.
Resources
CVM Guidance for Industry #263
GFI #263: Frequently Asked Questions for Farmers and Ranchers
List of Approved New Animal Drug Applications Affected by GFI #263
