New Antibiotic Rules Start in June

The U.S. Food and Drug Administration (FDA) has issued a new Guidance for Industry (GFI) regarding the marketing status of antimicrobial drugs for food animal medicine, effective June 11, 2023.

GFI #263 specifies that all “medically important” antimicrobial drugs – antibiotics that are approved for use in both human and animal medicine – shall be brought under veterinary oversight.

Products that traditionally could be purchased by anyone over-the-counter (OTC) now will be available by prescription (Rx) only by a licensed veterinarian. That means antibiotics like penicillin and oxytetracycline no longer will be available in most feed and farm stores nationwide.

In addition to injectable products, the new rules apply to other dairy medications like calf boluses and lactating and dry-cow mastitis tubes.

However, the Rx status does not require that these products be purchased directly from a veterinarian. The FDA notes that, while certain state requirements also may apply, you may be able to buy prescription animal drug products from various suppliers or distributors.

Those transactions will require a valid prescription provided by a licensed veterinarian, with whom you have a veterinarian-client-patient relationship (VCPR).

For more on antibiotics, read:

• What Antibiotics Will No Longer be Available Over-the-Counter?
• Over-the-Counter Antibiotics Are Going Away: 5 Tips to Prepare Your Farm