VFD rules now in effect
Changes were made in how the U.S. Food & Drug Administration (FDA) regulates most of the feed grade and water-soluble antibiotics you use. On Jan. 1, 2017, many antibiotics used in U.S. animals shifted from over-the-counter status to being available only under veterinary oversight.
Now is the time to ensure you are complying with the new rules as part of your cattle-health program.
“We are now several months into the new VFD rules,” says Kerry Keffaber, D.V.M. and Chief Veterinarian, Scientific Affairs and Policy for Elanco. “Fortunately, many resources are available and the industry is working together to ensure these rules are properly implemented.”
Here are the top 10 questions to ensure you are meeting the new VFD rules:
1. What products have been affected?
FDA is requiring the maker of any feed grade or water-soluble antibiotic it considers important to human medicine to change its table to ensure products are used under veterinary oversight, through a VFD or prescription, respectively. Because that change affects 19 chemical entities and more than 280 uses, it’s simpler to talk about what products are not affected: In cattle, Ionophores have not changed — as long as they’re not in combination with another antibiotic. Also, non-antibiotics like dewormers, coccidiostats, implants and beta-agonists have not been affected. Over-the-counter injectable drugs, boluses and topicals are still available.
2. So I have to have a veterinarian?
Yes. Any order for the labeled antibiotics, whether under a VFD in the case of feed or under a prescription for solubles, have to be signed by a veterinarian licensed to practice in the state where the animals are located. In addition, by signing the order, the vet is pledging, under penalty of discipline by the state’s licensing board, that he or she has done so only under a “valid veterinarian-client-patient relationship” (VCPR). In most cases, a VCPR means the vet:
- Is licensed
- Has become familiar enough with your operation and animals to assume responsibility for medical judgments
- Can demonstrate “Sufficient knowledge” of the animals to make at least a general medical diagnosis
- Will make themselves available for follow-up, including advice on using the antibiotic
3. What if I can’t find a veterinarian?
Despite some reported concern in other food-animal species markets that a shortage of knowledgeable veterinarians will make it difficult to get antibiotics under the new requirements, the American Association of Bovine Practitioners (AABP), the professional organization for America’s cattle vets, believes the supply of food-animal veterinarians is sufficient to cover any increase in demand. In fact, a 2013 study by the American Veterinary Medical Association showed that despite some problems with distribution, the nation actually has about 15 percent more food-animal vets than needed.
“We think every producer, with a few rare exceptions, will be able to locate a veterinarian to establish a VCPR and provide the necessary oversight so those cow/calf ranchers and feeder operators will be able to have access to the animal-health products they need,” says Ohio veterinarian Fred Gingrich, incoming executive vice president of AABP.
Gingrich advises any producer currently using these products to find a veterinarian. Once a veterinarian has been located, establish a VCPR, review the products you’re currently using or would like to use, then contact your feed distributor to ensure you can successfully implement the VFD.
4. Do I need a VFD before ordering?
VFDs provide direction to mix and to feed specific antibiotics to specific groups of animals. So a new VFD will be required for each use of a drug, and it expires after the amount of time specified on the order. At this point, you will not be permitted to store antibiotic premixes on the farm without a valid VFD for the premix. A VFD is not needed if the documentation requirements of a distributor have been met or you are using a Type A medicated article.
5. What forms do I have to fill out?
The VFD order is a form completed and signed by your veterinarian. If you were legally permitted to mix your own medicated feed prior to Jan 1, 2017, you are still allowed to do so. Consult your feed distributor for any additional paperwork requirements.
6. What information is required?
The VFD form requires specific information to ensure the product can be used correctly:
- Veterinarian’s and client’s name, address and telephone
- Specific site where the feed is to be used
- Date the VFD was issued and date it expires
- Name of the drug or drugs
- The species, production class (calf, cow, etc.) and approximate number of animals that will be treated with the medicine during the duration of the valid VFD
- Dosage, duration of treatment, withdrawal time and any special instruction
- Whether the drug can be used in a combination feed and which combinations
- What specific disease is being targeted? This must match the allowed diseases stated on the product’s label. There is no extra-label use of antibiotics in the feed for food animals. It must be for the indication at the dose and duration on the label.
7. Who has to keep the paperwork?
The veterinarian who signed the VFD keeps the original and the producer and the feed distributor receive copies. Electronic creation and storage is allowed if done on a compliant electronic system. Copies must be kept for two years and be available for FDA inspection.
8. Can we still use antibiotics preventively?
The new regulations still allow use of shared-class antibiotics (those used in both humans and animals) for therapy with veterinarian oversight. FDA defines therapy as treatment, control and prevention, and thus such prevention is considered a “judicious use” of antibiotics. If the drug was labeled for prevention before VFD, that label and use will still be approved.
9. Am I going to get inspected?
FDA has pledged to a policy of education during the transition to VFD. But it has also announced a pilot program that will involve inspection of not only feed mills but also veterinarians and producers. If inspected, a veterinarian will be expected to produce records documenting the VCPR with the client. For producers, the inspector will expect to find a copy of the VFD, and will check whether the medication went to the right number and type of animals for the right length of time, whether feeding continued past the VFD expiration, whether withdrawals were followed, whether it was used only in combinations with other antibiotics specified on the VFD, and that all the information matches feed labels.
10. Is this all really necessary?
Although some skepticism has been expressed about whether the new VFD process will impact public health by reducing antibiotic-resistance emergence, the beef industry’s cooperation and veterinarians’ compliance with the new regulations are important to instill consumer confidence and to maintain availability of antibiotics as they are needed, Elanco’s Keffaber says.
“Nobody likes more paperwork. No one likes to have more oversight and someone looking over their shoulder, especially if you’re convinced you’re doing everything right already. But we have to remember we’ve evolved into food producers, not simply animal producers. Part of the responsibility that comes with that is to explain to the consumer what we’re doing. And with responsibility comes reward, which is to maintain access to the tools we need to sustainably ensure animal health and welfare and protect human health.”
To access resources to aid you in the VFD process, visit VFD Central at feedstuffs.com/vfd-central and talk to your veterinarian.
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