This article was written by Paige Nelson and originally published in the Spring 2016 issue of Beef Vet magazine. It has been reproduced here with the explicit permission of the magazine.
Veterinarians Navigate the Nuts and Bolts of the Veterinary Feed Directive
Editor’s Note: The Food and Drug Administration Guidance #213 takes full implementation on January 1, 2017. Once implemented, producers are to obtain authorization from a licensed veterinarian to use antibiotics for production purposes. In Part 1, Paige Nelson introduces the Veterinary Feed Directive, guidelines, and implementation suggestions. Parts 2 and 3 will follow in
future issues of Beef Vet.
Order up! One veterinary feed directive (VFD) please! Hold the client complaints, add extra
paperwork (not extra label use), judiciously top it with plenty of producer meetings, and throw on a side of accountability. Oh yeah, have it ready by January 1,2017.
One of the largest orders to come down the regulatory pipeline affecting beef producers, veterinarians, and feed suppliers at the same time, VFD may not be exactly what the veterinarian prescribed, but most agree that it is doable.
The veterinary feed directive is the new law of the land that will go into effect January 1,2017. “Any (medically important) antibiotic that is put in a feed (or water) substance for cattle is going to need a VFD from a veterinarian,” defines Rick Sibbel, DVM, head of technical services for Merck Animal Health. The goal of VFD is to encourage judicious use of antibiotics in the animal agriculture industry. Ken Blue, DVM, a technical-services veterinarian for Elanco, adds, “There will be no production uses for those feed-grade antibiotics that fall under the VFD rule. Sponsors are in the process of removing all production uses for these VFD feed-grade antibiotics. All VFD feed antibiotics will only have indications for treatment and control of disease.
“There is no extra label use allowed for feed grade antimicrobials,” Dr. Blue continues. “If
you want to use a VFD product to treat a disease that is not on the label, at a level that is not within label indications, or for a time that is not indicated on the label, you cannot write a legal VFD for that product to be used…. If the label says for treatment of respiratory disease, that what it has to be used for, and it has to be used at the level and duration that is on the label.”
According to the U.S. Food and Drug Administration (FDA), a VFD is not the same as a
prescription, but it is similar. The FDA oversees both prescription drugs and VFD drugs, but while prescription drugs fall under state pharmacy laws, VFDs do not, and that is the distinction. Dr. Sibbel explains the VFD system as a triplicate form, in which the veterinarian retains the original document. One copy is sent to the feed supplier, and the
cattle producer keeps another copy. All VFDs must be on file for at least two years. The VFD only affects feed grade antibiotics. No injectable antíbiotics fall under VFD regulation. FDA is recommending that a VFD be valid for six months.
Medically important antimicrobials are those antibiotics that are used in both human and animal medicine, and those that are used in feed are deemed by the FDA as medically important and fall under the direction of VFD:
Non-medically important antimicrobials are antibiotics used exclusively in animals:
“If an antibiotic does not have the label that is for therapy or prevention; then that antibiotic cán’t be transferred into the VFD category. There aren’t going to be many,” Dr. Sibbel reports.
In order for a veterinarian to write a VFD, he or she must have a working veterinary-
client-patient relationship (VCPR) with the producer and must be licensed in the state the
Dr. Sibbel defines a VCPR as a situation in which the veterinarian visits the producer’s operation on a regular basis, basically giving the veterinarian the full medical picture as to how the operator produces animals, the type of animals that he or she produces, and the health condition of those animals.
In cases where a combination of a medically important drug and non-medically important drug/hormone are fed simultaneously, a VFD is required, i.e., tetracycline and melengestrol acetate (MGA).
“Because only one of those two drugs falls under VFD, you’ve got to have a VFD on file for tetracycline at the feed store,” Dr. Sibbel details. “Because it’s in combination with a drug not on VFD, the veterinarian has to put on the VFD that he’s scripting tetracycline in combination with MGA, as long as MGA is fed at the recommended dosage and the dosage of tetracycline follows the VFD.
“The veterinarian has to identify that it’s a combination VFD, and he has to identify the drug that’s being used simultaneously,” says Dr. Sibbel.
- Establish a working VCPR with clients. “The veterinarian is going to need to be on site because that’s going to be the interpretation of a more valid veterinary-client-
patient-relationship. Maybe not every month and maybe as infrequently as every six months, but, nevertheless, there has to be evidence that the veterinarian is
on-site,” explains Dr. Sibbel.
- Have a business relationship with the nearby feed stores. Get up-to-date on the feed products available. “In the cattle world we have big pieces of geography where there are far more feed stores than there are veterinarians. But I would tell you, it’s likely to be a very steep learning curve,” he predicts.
- Know and work with the area’s nutritionists. “Nutritionists know a lot about
antibiotics, so they’re going to want to use products that they’ve used in the past and had success with. If those products include antibiotics in the feed, they are going to have to have a relationship with the veterinarian. They are going to have to collaborate on creating the VFD so it is available for the nutritionist to use,” advises Dr. Sibbel.
- Writing a VFD. The process is simple, even if the implementation is not. Dr. Sibbel says a client (cow-call stocker or feedlot) will call their veterinarian and request a VFD antibiotic. The veterinarian, assuming there’s a valid VCPR, then writes the VFD identifying the specific antibiotic, the dosage for the prevention, control or treatment of the disease identified as the problem, and the expiration date.
“The government won’t provide the actual paperwork, but they will provide the template
that everybody pulls the paperwork from,” Dr. Sibbel says. “There are online electronic companies that are developing these templates, so that the veterinarian can literally go on his iPad and take care of this.”
The veterinarian retains the original VFD form and sends one copy to the client’s feed distributor and another copy to the client.
Per a recent announcement by the FDA, feed store and client copies may be hand- delivered, emailed, faxed, or mailed.
According to Dr. Sibbel, feed purchased under a VFD can only be fed while the VFD is active. For instance, a producer has a six month VFD for feed containing chlortetracycline. If the producer has feed left over after the VFD has expired, the feed is no longer valid and cannot be fed for that purpose.
“Feed inventory management by the producer hasn’t been a big issue because if you bought feed and they delivered feed, you had the latitude to use that feed whenever you wanted to. There is going to be at least some level of new management concern for feed inventory for producers,” says Dr. Sibbel. If one VFD antibiotic proves ineffective, the veterinarian may cancel it and write a new VFD for a different antibiotic, he adds.
The diversity of each cattle operation lends itself to unique situations for all. But a working VCPR, says Dr. Sibbel, decreases complications on all levels. He gives the following example.
A rancher raises 100 calves each year and backgrounds them. He purchases another 200 calves through the sale barn to feed with his own. These are generally high risk cattle and he needs to feed antibiotics. However, due to price and supply of calves through the ring, cattle purchases may be sporadic, and it may take a month or more to collect all 200. Because VFD feed is good only for the life of the VFD, the rancher may want to purchase his feed relative to his cattle numbers.
Dr. Sibbel emphasizes the possibility of having a VFD on file at the feed store, indicating that this rancher buys cattle for a period of time and will be buying feed-grade antibiotics for a period of time, too.
Veterinarians from around the country expect a few bumpy months following VFD’s effective date of January 1,2017. Nevertheless, the FDA has promised that there will be monitoring and audits to ensure rules are followed and rule breakers are found. But, are those promises empty handed?
Dan Stafford, DVM, of the Shiner Animal Hospital in Shiner, Texas, fears not the monitoring piece of VFD but the lack thereof. He says that there is no funding yet for FDA
or USDA to do any surveillance. “Are people going to figure out, “Okay, it’s a ghost program?'” he wonders. “There needs to be some teeth behind it. I don’t want anybody
to get in trouble, but a lot of times we’ve got to have a risk/reward situation where people
don’t start down that path because they aren’t going to get in trouble. I think they need to
nail down that monitoring and surveillance part a little bit better in the coming year.”
Dr. Sibbel says, as it is currently set up, the FDA and assigned personnel will handle monitoring of feed mills, while individual states are responsible for veterinarians
With less than a year before VFD takes hold, now is the time, says Sibbel, to begin training staff on extra paperwork and figuring out the best way to fit VFD into the veterinary profession.
These links were not part of the Beef Vet article, but we thought you might find them useful for added clarification on the topic.