GFI 263: FDA Limits Antibiotics in Livestock

GFI 263

Over-the-counter sales of specific medically important livestock antibiotics in the United States will end June 11, 2023. These medications will still be available, but they’ll require veterinarian prescriptions going forward. Owners have remarked that it’s already difficult, or impossible, to source antibiotics used to treat their livestock. While it’s supply chain issues for some, for many, it’s a result of drug manufacturers following the Guidance for Industry (GFI) No. 263, which was issued by the Food and Drug Administration (FDA) on June 11, 2021.

Battling Antimicrobial Resistance

The FDA’s intent is to combat antimicrobial resistance (AMR) to drugs also used in humans. It isn’t just limited to animals that’ll enter the food chain, but is also applicable to all livestock and companion animals. GFI No. 263 recommends that manufacturers of affected veterinary drugs voluntarily change their labels to reflect a new prescription-only status and obtain FDA approval prior to the 2023 effective date. Drugs that’ve been submitted for relabeling are listed on the FDA’s website, with status updates as they move through the process. According to Anne Norris, an FDA health communications specialist, the FDA intends to allow unlabeled inventory remaining in distribution channels to be depleted rather than recalled.

Concern about antimicrobial resistance has been growing and has resulted in changed practices, not only in the livestock sector, but also in horticulture and human medicine. The European Union banned the use of antibiotics in livestock as a preventative measure, beginning in January 2022. California implemented the veterinary prescription requirement of medically important antimicrobials in 2018. Veterinarians have the resources to recommend the most appropriate antimicrobials. The FDA maintains that “providing animals with the most appropriate antimicrobial is more likely to effectively resolve the infection and reduce the need for repeated or extended courses of antimicrobial therapy. This will not only help to reduce AMR risks, but will help to ensure better health outcomes for animals, and can also save time and money.”

Establishing a VCPR

To access medically important antibiotics going forward, animal owners will be required to establish a veterinarian-client-patient relationship (VCPR). The definition of VCPR varies from state to state, and it can be obtained by contacting the state’s veterinary medical board. Some states require, at a minimum, an annual on-site visit.

It’s strongly recommended that animal owners establish VCPRs during the transition period, so a veterinarian can become familiar with their animals, risks, and management. Plans can be developed for a variety of scenarios, such as when the veterinarian is unable, or doesn’t deem it necessary, to visit. This is critical for owners in areas lacking veterinarians, or veterinarians with the desired species specialty.

Katie Daniel, a large-animal veterinarian in Ohio, welcomes the change. “I can’t tell you how many times I get called out to a pen of half-dead animals after the producer treated them for weeks with sub-therapeutic doses. A valid VCPR means having antibiotic, dosages, and protocols on hand so a vet on the weekend is not necessary for an animal that needs treatment. Trust me, I don’t want my clients calling me on a Saturday night to treat a cough. They pay for my education and oversight, not to put out fires. It breaks my heart when I get called for too little, too late, when appropriate drug use early on would have saved a life and a lot of suffering.”

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Barriers to Access

Not everyone has a Dr. Katie. Animal owners are reasonably concerned about their ability to access treatment as a result of the change. The number of veterinarians who’ll see large animals is dwindling. Currently, according to the American Veterinary Medical Association, only 5.2% of vets practice large-animal and livestock care. When considered with a recent Mars Veterinary Health report, which indicates that the U.S. will need nearly 41,000 additional veterinarians just to meet the needs of companion animals by 2030, the prognosis for livestock looks grim.

Many owners have also voiced concern about the potential for increased costs, not only for professional services, but also for retail markup, making prescription drugs more expensive. FDA guidance doesn’t require the prescription to be purchased from a veterinarian. Prescriptions can be filled by online pharmacies; however, Amber McCoig, senior veterinary medical officer, science policy, for the office of the director at the FDA Center for Veterinary Medicine, advises caution when making unapproved drug purchases online. When asked if it was legal to “smuggle” drugs in one’s suitcase or to knowingly buy drugs that aren’t approved in the U.S., McCoig says, “Even if a type of drug is approved in the United States, if it’s purchased in or from another country and brought into the U.S., it’s considered an unapproved drug, because that specific drug hasn’t been approved by the U.S. FDA.”

Selling animals or animal-derived products adulterated with a violative drug residue in interstate commerce is illegal under the Federal Food, Drug, and Cosmetic Act. The FDA may follow up on violative drug residues detected in food derived from animals.

The FDA won’t speculate about the conditions under which it would prioritize investigating or prosecuting specific acts related to introducing injectable antibiotics into the U.S. from another country or for ordering injectable antibiotics from another country for use in a food animal. Both of these acts are against the law, so violators could potentially face legal penalties.

The practice of sharing supplies will also be impacted. When drugs were available over the counter, they could be shared without legal consequence if used as labeled. This isn’t the case with prescriptions.

“The FDA strongly advises against sharing prescription drugs of any kind,” says McCoig. “It may seem like a gesture of kindness to supply a friend with a prescription drug, but if it is the wrong drug, wrong dosage, or for other reasons, it could be a costly and/or fatal decision that is also against the law.”

Keep in mind that it’s also illegal to share over-the-counter drugs for extra-label use without a veterinarian’s prescription.

While the change is likely to achieve the desired result of reducing the use of medically important antimicrobials, producers caution there’ll be unintended consequences. Animals that would’ve received treatment with low-cost, accessible over-the-counter drugs may go without treatment, because the increased cost outweighs the potential income from that animal. Some fear it’ll be more economical to euthanize than treat, and animals may suffer needlessly from delayed treatment. Producers have also expressed fear that they’ll be charged with animal neglect when they’re unable to access veterinary care.

Looking to Alternatives

While many are opposed to the change, others embrace it and have begun exploring alternatives to antibiotics. There’s some risk in this realm as well, as the efficacy of many anecdotal treatments has been disproven in studies. The FDA prohibits any supplier from making health claims about products that aren’t reviewed and approved by the FDA, a process that requires manufacturers to prove the product is both safe and effective. While preventing companies from marketing unsafe products and those with unsubstantiated claims, this also makes it more difficult to know how and when to use alternative treatments.

Molly’s Herbals is a well-known source of herbal supplements, but even Molly cautions on her website that herbs, while a potentially useful form of complementary medicine for animals and people, can be dangerous. It may not be safe to use a particular herb in certain animals or during certain conditions, such as pregnancy. Consumers are highly encouraged to educate themselves on the herbs before using them on animals or themselves.

Certain drugs may have adverse side effects when combined with herbs that haven’t been thoroughly studied and tested. If owners diagnose their own animals but get the diagnosis wrong, therefore selecting the wrong treatment, it could make matters much worse. When in doubt, consult a veterinarian.

In the long term, these changes could also impact the diversity of animals raised. Some producers are selecting for individual animals, breeds, or species with stronger immune systems. In dairy operations, for example, animals prone to mastitis will become a greater liability with reduced access to treatment, and will be more likely to be culled. When animals are selected for hardiness on an individual basis, this practice can improve a breed. However, domestic breeds or species that are notorious for their fragility may become too costly to maintain; as a result, fewer producers will be willing to keep them, which could result in them being placed in conservation or threatened status.

Preparing for the Future

There’ll be costs and benefits to the implementation of GFI No. 263. And, as with all change, there will be discomfort. Up until now, many have relied on fellow livestock enthusiasts to offer advice on treatment and protocol. GFI No. 263 will limit many of these treatments to veterinary oversight. However, there are many benefits to working with a vet — professionals with extensive training, who keep in mind the animal’s needs plus the potential risks of antimicrobial resistance. Establishing best management practices, such as vaccinations and disease prevention plans, will reduce the overall need for antibiotics.

For the animals in our care, we must do our best to ensure their quality of life. If you haven’t yet identified a veterinarian who will partner with you to care for your herd, now is the time.

Resources to Help Navigate GFI No. 263

Antibiotic Stewardship for Sheep and Goats:

• English
• Spanish

Find Veterinarian Board websites by state.

Information on violative drug residues in animal products.

To tell whether a drug has been approved by the FDA, look for an FDA NADA number on the label or search FDA-approved animal drugs online.

Affected Drugs

A quick reference of drugs moved under GFI No. 263 guidelines*:

• Cephapirin
• Cephapirin Benzathine
• Chlortetracycline
• Dihydrostreptomycin
• Erythromycin
• Gentamicin
• Lincomycin
• Novobiocin
• Oxytetracycline
• Penicillin G Benzathine
• Penicillin G Procaine
• Polymyxin B
• Spectinomycin
• Sulfabromomethazine
• Sulfachlorpyridazine
• Sulfadimethoxine
• Sulfamethazine
• Sulfomyxin
• Sulfisoxazole
• Tylosin

*Visit the FDA online to see the full list of approved new animal drug applications affected by GFI No. 263.

Karen Kopf and her husband, Dale, own Kopf Canyon Ranch in Troy, Idaho. They enjoy “goating” together and helping others goat. You can learn more about them at Kopf Canyon Ranch on Facebook or at Kiko Goats.