All over for OTC

Remaining nonprescription livestock antibiotics will soon only be available through veterinarians

By next June, producers will no longer find most over-the-counter livestock antibiotics on the shelves or in the animal health cooler at their local MFA or AGChoice location. Instead, a veterinarian’s prescription will be required to purchase these medications.
The change comes as an extension of Veterinary Feed Directive (VFD) regulations, which went into effect in 2017 by the Food and Drug Administration and brought most antibiotic use in the livestock industry under veterinary supervision. However, a small percentage remained available over the counter (OTC) in the form of injectables, intramammary tubes, boluses and topical products.

With the next step in the FDA’s Veterinary Feed Directive rules, which first went into effect in 2017, most remaining over-the-counter livestock antibiotics will only be available by veterinarian prescription. The antibiotic forms affected include injectables, boluses, intramammary tubes and topical products.“We knew shortly after the VFD regulation was implemented that the remaining OTC versions of these same antibiotics would likely be the next group to be regulated,” said Dr. Tony Martin, MFA Incorporated manager of animal health. “Since that was confirmed last year, we’ve been proactively working to make sure our locations and customers are prepared for the changes.”

Current products that will be affected include penicillin, tetracycline, erythromycin, sulfamethazine, sulfadimethoxine and tylosin, among others. Producers will find familiar names such as LA-200, Bio-Mycin, Terramycin and Sustain III on that list.

“For MFA, this means the loss of our ability to carry these products, which include antibiotics commonly used to treat issues such as pinkeye, calf scours, infections, pneumonia and other respiratory diseases,” Martin said. “For producers, it means that instead of being able to make their own judgment call when they need an antibiotic, they will have to go to a veterinarian to get a prescription and either buy that product from their veterinarian or take it somewhere else to fulfill.”

The affected antibiotics are considered “medically important,” which means they are also used in some form to treat human disease, and the FDA says the stepped-up regulations are part of a broader stewardship effort to combat resistance to these drugs. The intent is to only allow veterinarians to prescribe antibiotics when necessary for the treatment, control or prevention of specific diseases in food-producing animals.

By June 11, 2023, the FDA expects all of the “medically important” antibiotics that are currently available over the counter to display the following statement on the label: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” As soon as animal health companies make that label change—even if it’s before the deadline—the product will be prescription only, Martin said.

Legally, prescriptions must be issued through an established veterinarian-client-patient relationship. In Missouri, this means a veterinarian is acquainted with the producer and the animals either by examination or timely visits to the operation.

“The veterinarian should know enough about the producer and the farm to be able to make the medical judgment and be available for follow-up if there are problems,” Martin explained. “And the producer is agreeing to follow the veterinarian’s recommendations. The relationship has to be more than just over the phone.

He encourages farmers to consult with their veterinarian to have a plan in place during this transition period, including how to access appropriate antimicrobial products when a veterinary visit is not feasible or not considered necessary.

“Understand how it’s going to affect you, know what products you’re going to start having more restricted access to and discuss what your veterinarian’s approach is going to be to providing prescriptions for those products,” Martin advised. “Open the line of communication now and talk about what this is going to mean to your operation.”

The new rules could add more stress to rural veterinarians who are already in short supply. The U.S. Census Bureau anticipates a possible national shortage of 15,000 veterinarians by 2025, with the bulk of those needed in rural areas. Only about 10% of final-year veterinary students express an interest in working with livestock after graduation, according to recent survey data from the American Veterinary Medical Association.

“I’m afraid it’s going to bring even more awareness to how unavailable that veterinary resource is in a lot of our trade territory,” Martin said.

Julie Braun, executive director of the Missouri Veterinary Medical Association (MVMA), doesn’t share that concern. Since the VFD guidance was first published in the federal register in 2013, she said the association has been working to make its members aware of the regulatory changes so they are prepared to serve their producer-clients. The topic will also be presented at the MVMA’s annual convention in January to address this latest extension.

“Veterinarians and livestock producers should be exercising this practice with the antibiotics that are already under the federal law, so I don’t think there is going to be a huge change,” Braun said. “They’re already going to have that relationship set, which is good. The whole point is to put antibiotic usage under the jurisdiction of the veterinarian so that it is used properly and thoroughly to prevent antibiotic resistance.”

Braun said she expects veterinarians to handle prescriptions under the new rules differently, depending on the situation with each client. She also said the price difference of prescription-versus-OTC medications is unclear at this time, adding that “veterinarians have no control over that.”

Both Braun and Martin agree that livestock producers who do not currently use a veterinarian on a regular basis are the ones who will be most affected by the changes. They encourage those farmers to establish a valid veterinarian-client-patient relationship before June to ensure continued access to antibiotics when needed.

By June 2023—or before— customers will no longer be able to find livestock antibiotics such as these stocked on the shelves at their local MFA store. As soon as animal health manufacturers label these products as “prescription only,” they cannot be sold over the counter.In Missouri, any entity within the state selling, dispensing or filling orders for animal prescription drugs, with the exception of a veterinarian, is required to have a pharmacy permit—an expensive and complicated process. That’s why Martin said MFA will no longer carry most livestock antibiotics after the June 2023 deadline, with the exception of a few minor products.

However, Martin emphasizes that producers will still be able to purchase feeds with antibiotic additives through MFA with a valid VFD as well as a full line of animal health products that do not require prescriptions. He also stressed that antibiotics aren’t always the answer.

“These restrictions are going to put even more focus on the importance of genetics, nutrition, management and preventive animal health practices that all livestock producers should be doing,” Martin said. “Are you minimizing the stressors? Are you feeding a fully balanced diet? Are you doing a good job with parasite control and vaccinations to minimize disease? Are you using additives like Shield Technology that help support immunity?”

“We can’t totally do away with the need for antibiotics,” he added. “I’ll admit that up front. But we can try to minimize the occurrence of disease and keep animals at a higher level of health so we will need less of them.”
For more details from the FDA on the new rules, visit online at https://www.fda.gov/animal-veterinary/cvm-updates/fda-finalizes-guidance-bring-remaining-approved-over-counter-medically-important-antimicrobial-drugs.

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