FDA guidance to bring antibiotics under vet oversight


By Julie Tomascik

Each year brings new changes and new regulations. And next year’s changes could include more veterinary oversight for medically-important antibiotic use in food animals.

The U.S. Food and Drug Administration (FDA) is continuing to phase in a law that requires a prescription for any antibiotic used in animals raised for human consumption, as well as for all companion animals.

A prescription is already required for most antibiotics administered to livestock through the Veterinary Feed Directive (VFD), which was implemented in January 2017.

The VFD requires a valid veterinarian-client-patient-relationship for farmers and ranchers to get prescriptions for the use of feed-grade and water-soluble antibiotics.

A limited number of other dosage forms of medically-important antimicrobials, such as injectables, are currently marketed as over-the- counter products for both food-producing and companion animals.

These new guidelines will further extend the need for veterinarian oversight, noted Tracy Tomascik, Texas Farm Bureau associate director of Commodity and Regulatory Activities.

The remaining three categories of injectable antibiotics that are available over-the-counter would be added to the list of medically-important antimicrobials that require a veterinarian’s prescription.

“Tylosin, penicillin and tetracyclines are among the more popular antibiotics still available over-the- counter as injectables, but that will change,” Tomascik said. “A relationship with your veterinarian will be even more important moving forward with these expected changes.”

The concern, Tomascik noted, is that antibiotic-resistant bacteria could develop more quickly from the widespread use of antibiotics that are medically important to humans.

“That would negatively impact both humans and animals,” Tomascik said. “But it’s important to note that antibiotics are not going away. Farmers and ranchers will have access to the same products, but their veterinarian will need to be involved to help make the appropriate decision. Ranchers won’t be able to go into the feed store and buy the products they need over-the-counter. It will take a little more planning and communication with their veterinarian.”

The increased oversight also applies to companion animals.

FDA’s Center for Veterinary Medicine’s goal is reduce the need for antibiotics, and a cooperative effort between veterinarians and farmers can help make that a reality in many cases.

In fact, FDA studies show antibiotic use in animal agriculture has declined in recent years.

“Judicious use of antibiotics in agriculture is important,” Tomascik said. “Working together, farmers, ranchers, veterinarians and consumers can all feel confident that both animal health and human health will keep in good standing.”

This is part of the FDA’s five-year plan for Supporting Antimicrobial Stewardship in Veterinary Settings.

When the rule is fully implemented, all dosage forms of all approved medically-important antimicrobials for all animal species can only be administered under the supervision of a licensed veterinarian and only when necessary for the treatment, control or prevention of specific diseases.

FDA is proposing a two-year implementation period that would begin after the agency considers comments on the draft guidance and issues the final guidance, but compliance is expected to begin as soon as 2020.

Comments on the draft guidance will be accepted through Dec. 24.

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