Industry Guidance: New antibiotic regulations require licensed veterinarian prescriptions

On June 11, 2021, U.S. Food and Drug Administration (FDA) published Guidance for the Industry (GFI) #263 removing any medically important antimicrobials – previously left untouched by the GFI #213 – from over-the-counter (OTC) markets.

GFI #213, published in 2017, required veterinarian oversight of medically important antimicrobials administered via feed and/or water, but left the antimicrobials being administered other ways untouched. GFI #263 is requiring certain products be removed from OTC availability to prescription by June 11, 2023.

This means producers will only be able to use these products under the supervision of a licensed veterinarian. Common products expecting to see label changes include: oxytetracycline, penicillins and tylosin.

FDA says the new regulations are “part of a broader effort by FDA to combat antimicrobial resistance (AMR). Using antimicrobials judiciously, in all settings, can help slow the rate at which AMR develops.”

Veterinarian oversight 

Although this new regulation may seem to be a hassle for producers, there are benefits to having a veterinarian’s oversight when administering antibiotics.

Dr. Dean Smylie, with Advanced Animal Care in Douglas says, “When you are targeting a specific disease with a specific medication, you are always better off to have as clearly defined diagnosis as possible. Correct antibiotics for specific diseases are often utilized better when there’s a veterinarian involved.”

He mentions misuse of antibiotics is not commonly seen by livestock producers in Wyoming. 

“Misuse is not near as common as it used to be,” he adds. “When I started practice 30 years ago, I think it was very common to see antibiotics misused.”

Smylie doesn’t feel the new regulations are necessary for animal health and assumes the regulations will be met with resistance from producers.

“The amount of misuse is not nearly as bad as a lot of perception makes it seem, and these regulations won’t really have a big impact on animal health,” he says.

Veterinary-client-patient relationship

Producers will not be required to purchase these products from a veterinarian under the new regulations, but they will be required to acquire a prescription from a licensed veterinarian they have an established Veterinary-Client-Patient Relationship (VCPR) with.

“When a VCPR is in place, the veterinarian assumes responsibility for making clinical judgements about the animal – the veterinarian has enough knowledge of the producer’s facilities and overall management practices allowing the veterinarian to make reasonable recommendations to the producer,” Smylie says. “The veterinarian also needs to be readily available for emergencies when there’s a VCPR established.”

Sale of antibiotics

With previously OTC products now requiring a veterinarian’s prescription, feedstores may not want to keep the drugs on their shelves anymore. There will be more paperwork for store employees to keep track of with these products requiring legal prescriptions.

“Veterinarians have always assumed liability of drugs they sell on a prescription basis, feedstores could sell the same drugs and have no liability,” Smylie says. “These new regulations require all specified drugs must have a veterinarian under liability to prescribe the vaccination – feedstores can sell antibiotics, they just need a prescription for it.”

Kaitlyn Root is an editor for the Wyoming Livestock Roundup. Send comments on this article to roundup@wylr.net.