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REMINDER TO GET PRESCRIPTIONS FOR USUAL OVER-THE-COUNTER CATTLE HEALTH PRODUCTS
June 11, 2023 is a date livestock producers have been made aware of for quite some time. This date is the designated time which antimicrobial drugs that were previously available to many livestock producers over the counter will no longer be available without a current veterinary prescription.
The U.S. Food and Drug Administration (FDA) issued this new Guidance for Industry (GFI) regarding the marketing status of antimicrobial drugs for food animal medicine in June 2021, giving veterinarians and livestock producers two years to make plans for the change. That time is now upon us.
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 livestock medications like calf boluses and lactating and dry-cow mastitis tubes.
However, the prescription 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).
A prescription has already been required for many livestock antibiotics. In 2013, FDA introduced a Guidance for Industry document, called GFI 213. Over three years, it phased in veterinary oversight in prescribing medically important antimicrobial drugs used in the feed or drinking water of foodproducing animals. The drugs had previously been available over the counter.
For questions or concerns about this next phase of prescription regulation impacting livestock owners, it is advised to develop a plan with you veterinarian before June 11.