The new Food and Drug Administration antibiotic rules are here. The tried-and-true medicated feed additives containing “medically important” antibiotics are not available over the counter. The days of grabbing a bag of crumbles at the feed stores are over. In the first few months, the veterinary feed directive paper chase may just seem like utter chaos. “The transition was going very smoothly until we started actually getting VFDs,” jokes Dennis Meirick, Farmers Mill co-owner.

The Iowa feed mill has been preparing for the revised rules that expand the list of medicated feeds that require VFDs written by a veterinarian before any feed ration can be mixed, sold to a customer or fed to an animal. Meirick’s team has prepared for the regulation change since the finalization of the rule in June 2015 by taking proactive steps in handling transition labels, outlining VFD protocol clearly and defining designated space in the feed warehouse. Yet, it was hard to predict how the actual implementation of the regulations would go down, leaving veterinarians, feed distributors and livestock producers wading through a sea of government red tape.

It’s all about the words

The VFD process starts with a veterinarian who works closely with a herd, making a series of decisions, and is the ring leader of the paperwork chain. As required by the regulation, the VFD must include accurate information including (but not limited to) the drug level, duration, the approximate number of animals being fed and expiration date.

Basically, you now have veterinarians involved in calculating your feed rations that contain VFD-listed drugs. While nutrition and animal health go hand in hand, feed formulation is not a normal conversation with the veterinarian. Normally, animal health discussion is focused on pigs backing off feed. So, now the feed salesperson or nutritionist is stuck in the middle of an exasperating circle, explaining feed formulations to all parties involved. As a result, the feed distributor is left being the interpreter. In these first few months under the revised VFD rules, Meirick spent a lot of time passing feed labels to veterinarians.

A majority of the confusion comes down to the terminology. For the producers, the feed product’s branded name is the norm, while the veterinarian is speaking in terms of an antimicrobial agent. While the FDA and numerous educational opportunities listed the information required to appear on a VFD, Meirick says it is hard to tell how specific it needs to be. For instance, veterinarians write the drug name or generic drug name, but the branded product is not listed.

Another issue is the measurement conversion. The veterinarian is working in milligrams per body weight whereas the feed mill and the livestock producers work in tons. So, now the feed mill is instructed to mix a topdress feed ingredient in terms of grams per tons of feed. Meirick says it is not uncommon to have two entirely different directions for one medicated feed item; the dosage and directions do not match. When asking for clarification, the feed mill is just instructed to keep good records. “If we get that stuff ironed out, then VFD will not be a big deal,” he adds.

After all, hog diet formulation was not on the veterinarian list of duties during those long years of medical school. “Veterinarians are not nutritionists. They are doing the best job they can on what they know,” notes Meirick.

Still, diet formulation is an essential factor in optimizing peak pig performance, especially during stressful times. Delivering the antimicrobial to the animal at the right time at the right dosage level can either prevent the pig from getting sick or put it on a faster wellness track.

Since a feed batch containing a VFD drug cannot be fed past the expiration date, mixing the right amount of feed for the group of animals is also crucial. As a large component of the input cost, the feed is too expensive to waste on guessing games or having some left over in bins.

Even though the process has been confusing and frustrating at times, the VFDs are being generated, and no feed order has been delayed, at least for Farmers Mill. “There has been a little inconsistency on direction on dosage and duration on VFD; however, the feed has gone out,” Meirick confirms.

All parties involved will have to pull their resources together to get a more practical, streamlined process moving forward, concludes Meirick.

Working with the veterinarian

Regardless how much of a paper chase the VFD process becomes, all parties have responsibilities and an active role, but the livestock producer must follow the chain of command to ensure a valid VFD. Chris Rademacher, Iowa State University swine Extension veterinarian, told the Iowa Pork Congress at its recent meeting that the hog farmer’s responsibility comes down to three things.

■ Valid VCPR: Although any licensed veterinarian can write a VFD, the regulation clearly states a livestock producer must secure a veterinarian-client-patient relationship. The livestock producer must establish a VCPR with a veterinarian who works closely with the operation. The VFD can only be written by a veterinarian with a valid VCPR, not the clinic.

Also, the regulations state the veterinarian must conduct a timely visit to the premises. While the “timely visit” is not clearly defined, Rademacher said that was 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 explained it will be a state-to-state decision, as well.

■ Valid VFD: The producer must ensure it is a valid VFD by starting the chain by contacting the veterinarian. The veterinarian provides oversight of treatment, compliance and outcome, and the producer agrees to follow the instructions provided by the veterinarian.

■ Documentation: All parties must keep records for two years. The livestock producer must receive a copy of the VFD from the veterinarian. Rademacher advised the producers to fully document all actions related to the VFD, including confirmation that the VFD feed is fed in accordance with the veterinarian’s instructions — duration, dosage and number of feeds.

Every VFD includes one veterinarian, one feed distributor and one hog producer. Complying with the revised VFD provides a good opportunity to review feed budgets by pig flow, and medication program, explained Paul Thomas, DVM at AMVC Management Services. 

“Just sit down and think through it. Instead of saying this is what feed medication programs are, write VFD to cover it and send them in,” said Thomas. “It is a good time to look at feed medication programs. Do they make sense? Are you meeting the legal requirements for time and indication?”

He further advised to step back and ask yourself if your operation is meeting “the spirt of the law.” It is a suitable time to trim out unnecessary feed medication uses.

In certain circumstances, an extra step in documentation may need to be added to the standard management practices. In his experience, Thomas said, most recordkeeping was not adequate. At the farms AMVC manages, extra items that needed to be recorded were added to the sheets at the barn.

One area of improvement was recording feed deliveries. Since FDA wants to know when a drug started and finished, Thomas suggested taking an extra step in documenting feed deliveries to the barn. At the farms his company manages, they record every feed delivery and ticket numbers that came to the farm. The tickets are kept at the barn, and the bin number is noted.

The start and finish time of feeding the medicated feed is also recorded. The bottom line is to make it easy in the future to calculate the days the medicated feed has been fed, especially if asked by an FDA inspector.

Along with retaining a copy of the VFD, the producer needs to document that feed medications are being used appropriately according to the instructions on the VFD. It is important to keep the VFD on the farm for two years along with related documentation.

Another challenging area is pulse feeding, using the same antibiotic on the same group of animals at two different times during the animals’ time period to control a certain pathogen. While some look at that as a refill, technically it is not. Refills are only allowed if labeled appropriately. There is no animal feed containing a VFD-listed antimicrobial labeled for a refill, clarified Rademacher.

It is important to follow the drug label and VFD instruction, stressed Thomas. From the FDA’s perspective, administrating an antibiotic for the second time on the same animals is considered a treatment fail. So, producers and veterinarians need to carefully evaluate the situation and use current diagnostics to determine if pulse feeding is necessary.

The current recommendation is to write two separate VFDs. Rademacher gave the following example: If a hog farmer wants to give antimicrobial in the finishing barn for the first two weeks and six weeks later give the same antimicrobial again for respiratory disease, then a veterinarian needs to write two different VFDs.

The veterinarian will need to do a good job in documenting why a second VFD is written. Therefore, the reason for the second treatment needs to be specifically documented, explained Thomas.

In conclusion, an outstanding working relationship with your veterinarian is essential for a smooth VFD process. Thomas gave the following guidance:

■ Be proactive in communicating with your veterinarian to get VFDs in place.

■ Be aware that it is going take time to obtain a VFD.

■ Depending on the VCPR, the veterinarian may need to visit the farm more frequently.

■ Additional documentation is unavoidable.

With the expanded list of drugs requiring a VFD, more on-farm inspection will occur. Although the FDA indicates a probation time for compliance, for now, Thomas suggested producers step up their game, especially the level of documentation.

Your tough questions about VFD compliance answered

The new FDA antibiotic rules have now been effect for a few months. 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 the veterinary feed directive has dominated the educational 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, answered the tough questions about VFD compliance. Here are the top questions.

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,” said Verzal.

He further explained 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.

FDA’s current list of VFD-listed drugs is at www.fda.gov/AnimalVeterinaryDevelopmentApprovalProcess/ucm482107.htm.

What are the top two things producers, veterinarians and feed distributors can do to stay in compliance with FDA?

1. Documentation. “Documentation is the key,” said Rademacher. You cannot document enough. Any conversation, including a simple phone call about an antibiotic 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, said Verzal.  While not required, special instructions included on the VFD for the feed manufacturers and pig caretaker 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: “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 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 reminded hog producers that a VFD is written by one veterinarian, not the clinic.

What does “timely visit to premises” mean?

Rademacher said that was probably intentionally left vague by the FDA. There is no precise definition. It will be judged on a case-by-case basis. He further explained it will be a state-to-state decision. In some states, government officials have stated that “timely” means a visit annually.

As an inspector, Verzal said it does not take long during an inspection on the farm or at the veterinarian clinic to determine if a veterinarian routinely visits the farm and has a solid VCPR. It becomes clear through the discussion with the producer and veterinarian.

Thomas explained that each farm is unique. There are some farms that communicate with a veterinarian on regular basis, and the veterinarian has a steady stream of diagnostics available at his or her fingertips. “I have complete snapshot and visit every month” is not necessary.

So as a veterinarian, “it really comes down 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, Thomas said.

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 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 it electronically, she or he needs to store it electronically. If a VFD with all required information is written on 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 said if a 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 must do. 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 animals’ time period to control a certain pathogen, explained Rademacher. Some look at that as a refill, but that is incorrect. 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 to write two separate VFDs. Rademacher gave 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 again for 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’s 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 a designated inspector to conduct on-farm inspections. Rademacher listed 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 give feed containing a VFD-listed drug to sick pigs?

The veterinarian will issue an expiration date on the VFD. The maximum amount of time a VFD can be issued and the duration of feeding is defined by an 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 reminded 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.