The new Food and Drug Administration antibiotic rules have now been effect for four weeks. All “medically important” antibiotics used in mass medication in feed or water will not be available over-the-counter. For some time now, education on Veterinary Feed Directives has dominated the education seminars and publications for America’s pig farmers and frankly, all animal agriculture. Many resources exist.
It is now time to comply and new questions arise. At the Iowa Pork Congress, Chris Rademacher, DVM and Iowa State University Swine Extension Veterinarian; Jeff Verzal, Iowa Department of Agriculture compliance investigator and Paul Thomas, DVM at AMVC management services, answer the tough questions about VFD compliance. Here are your top questions answered.
So are VFD drugs considered prescription drugs?
Although similar in concept, VFD listed drugs are not prescription drugs. “Specifically, what we are referring to today is feed additive medication," says Verzal.
He further explains these feed additive medications cannot be used in an extra-label use manner. It was never allowed, and the revised VFD did not change this regulation.
The current list of VFD listed drugs can be found at fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm482107.htm
What are the top two thing producers, veterinarians and feed distributors can do to stay in compliance with FDA?
1. Documentation: “Documentation is the key,” says Rademacher. You cannot document enough. Any conversation including a simple phone call about antibiotics on the VFD list needs to be recorded. Although it seems like paperwork overload, it is essential to demonstrate compliance.
2. Communication: All parties involved in the VFD process from pig caretaker to veterinarian to feed mill must fully understand the instructions. Clear communication is just as important as documentation, says Verzal. While not required, special instructions included on the VFD for the feed manufacturers and pig caretakers will only diminish confusion.
Can any licensed veterinarian write a VFD?
The short answer is “no.” The federal government defines the veterinarian-client-patient relationship as a “Practicing vet is readily available for follow-up in case of adverse reactions or failure of regimen of therapy. Such a relationship can exist only when the vet has recently seen and is personally acquainted with the keeping and care of animal(s) by virtue of examination of an animal(s), and/or by medically appropriate and timely visits to premises where animal(s) are kept.”
Basically, a valid VCPR is with a veterinarian who you as producer work with on a regular basis, who has seen your animals, visits the farm regularly and can provide follow-up treatment if necessary. Rademacher reminds hog producers that a VFD is written by one veterinarian NOT the clinic.
What does timely visit to premises mean?
Rademacher says that is probably intended to be left vague by the FDA. There is no precise definition. It will be judged on a case-by-case basis. He further explains it will be a state-to-state decision. In some states, government officials have stated that “timely” means an annual visit.
As inspector, Verzal says it does not take long during an inspection on the farm or at the veterinarian clinic to determine if the veterinarian routinely visits the farm and has a solid VCPR. It becomes clear through the discussion with the producer and veterinarian.
Thomas explains that each farm is unique. There are some farms that communicate with a veterinarian on a regular basis and the veterinarian has a steady stream of diagnostics available at his or her fingertips. If a complete snapshot is available then a visit every month may not be necessary. So as a veterinarian, “It really comes down to feeling comfortable in understanding what the health of those animals are and what the practices are on that farm” before writing a VFD for a particular site, states Thomas.
Does a veterinarian license number need to be on the VFD?
No, the veterinarian license number does not need to be on the VFD. However, the veterinarian needs to be licensed in the state the VFD is written.
What format can I use to store my VFD?
The VFD must be a written statement, not verbal. It can be a hard copy or electronic. The veterinarian, hog farmer and feed store must store the VFD for two years. The veterinarian is the originator of the VFD. Once your veterinarian writes the VFD, it needs to be stored in its original format. If the veterinarian generates electronically, she or he needs to store it electronically. If a VFD with all required information is written on a napkin, then that napkin needs to be kept. The hog farmer and feed distributor can store their copy of the VFD in any format.
I manufacture the feed for my animals on the farm. Are we exempt from VFD rules?
No, on-farm feed mills are not exempt from VFD rules. Even though the farm is only producing feed for animals on the farm, the operation is still required to follow VFD requirements for feed distributors. Furthermore, Verzal says if the farm is manufacturing medicated feed on the farm, then it is required to keep records of the receipt and distribution of all medicated animal feed containing a VFD drug for two years just as all commercial feed manufacturers. These records must be available at the on-farm feed mill inspection.
What about pulse dosing?
It is defined as using the same antibiotic on the same group of animals at two different times during the animal’s time period to control a certain pathogen, Rademacher explains. Technically, some look at that as a refill, but that is to the contrary. Refills are only allowed if labeled appropriately. There is no animal feed containing a VFD listed antimicrobial labeled for a refill.
The current recommendation is writing two separate VFDs. Rademacher gives the following example: If a hog farmer wants to give an antimicrobial in the finishing barn for the first two weeks and six weeks later give the same antimicrobial for a respiratory disease, then a veterinarian needs to write two different VFDs.
Also, the veterinarian will need to do a good job in documenting why a second VFD is written. From the FDA perspective, administrating an antibiotic for the second time on the same animals is considered a treatment fail. Therefore the reason for the second treatment needs to be specifically documented.
What questions will an inspector ask during a visit?
Each state will have designated inspectors to conduct on-farm inspections. Rademacher lists the top questions likely to come up during an inspection.
- Does the client keep copies of VFD orders for at least two years?
- Did the client feed the VFD feed to the authorized number of animals on the VFD order?
- Did the client feed the VFD feed for the identified duration on the VFD order?
- Did the client stop feeding the VFD feed before the expiration date on the VFD order?
- Did the client follow the withdrawal period for the VFD feed, if any?
How long can I feed the sick pigs containing a VFD drug?
The veterinarian will issue an expiration date on the VFD. The maximum amount of time a VFD can be issue and the duration of feeding is defined by expiration date on the label with a maximum of six months.
It will take intense coordination between the veterinarian, producer and feed distributor to calculate the amount of feed needed for the sick pigs during the VFD time period. However, it is realistic to have leftover feed because often sick pigs do not eat as well as healthy ones. No one wants feed to go wasted and it is important for sick pigs to get the right dose for the right duration.
If for some reason feed containing a VFD drug is leftover in a bin, Rademacher reminds producers that it can be used in the future for prevention or treatment if determined by a veterinarian that it is necessary to feed the same dosage and ration but a new VFD needs to be written.