Over-The-Counter Access to Antibiotics is Going Away

Access to antibiotics continues to change for U.S. livestock producers. Soon, antibiotics likely will not be available over-the-counter (OTC) through traditional retail channels at all.

When the Veterinary Feed Directive (VFD) took effect in 2017, the use of “medically important” antibiotics – those products that were used in both human and animal medicine – was placed under greater veterinary oversight.

Medically important antibiotics in feed and water were removed from OTC channels. But the regulations did into address OTC antibiotics delivered via other methods like injectables, boluses, and intramammary mastitis tubes.

Since then, the U.S. Food and Drug Administration (FDA) has issued a new directive to bring all OTC drugs under veterinary oversight. “Guidance for the Industry #263” recommends that sponsors of medically important antimicrobial drugs voluntarily transfer them to prescription marketing status. This would include label language stating, “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

In a University of Nebraska bulletin on the regulatory shift, authors Becky Funk, DVM, and Jesse Fulton pointed out, “while this change does not require the purchase of products from a veterinarian, going forward, producers will be legally required to obtain a prescription from a licensed veterinarian with whom the producer has a valid veterinary-client-patient relationship.”

The Nebraska advisors said many feed and farm stores do not have the framework in place to meet the legal burden of acting as “pharmacy,” which requires the ability to review veterinary authorized prescriptions and track refills of prescription products. If they do continue to stock those products, customers will have to show a prescription prior to purchasing them.

“It is important to remember that these critical products are not being removed from the marketplace, but instead being brought under veterinary oversight,” they said.

They advised producers not to “stock up” on these products, because they can expire and lose their effectiveness before being used.

Products unaffected by the change include ionophores; antiparaciticides; injectable and oral nutritional supplements; oral pro/prebiotics; and topical non-antibiotic treatments. These products will continue to remain available through standard OTC marketing channels.

Guidance #263 is slated for final implementation on June 11, 2023. Between now and then, many once-familiar products likely will start disappearing from store shelves. Producers should work with their veterinarians to develop a plan to adjust the way they access their animal health products.