Feeder full of hog feed National Pork Board

Using a VFD-listed drug? FDA inspection is inescapable

Ignoring the new FDA antibiotic rule is not an option if a hog farmer plans to administer “medically important” antibiotics in the feed or water.

“If it is not written down, then it did not happen” may be an adage, but not complying with the new Food and Drug Administration antibiotic rules can sooner or later catch up with you, warns Jeff Verzal, Iowa Department of Agriculture compliance investigator.

Ignoring the new FDA antibiotic rule is not an option if a hog farmer plans to administer “medically important” antibiotics in the feed or water. Effective Jan. 1, an expanded list of antimicrobials requires a due process, starting with veterinarian oversight before feeding to pigs. For those “medically important” antibiotics used in the feed, a veterinary feed directive is required or a prescription for water medications.

Technically, VFDs are not new for hog producers. Before the change, avilamycin, florfenicol and tilmicosin were already on the VFD list, requiring documentation and veterinarian oversight. Now, the VFD list is expanded, and rules are revised.

VFD compliance means all parties involved — hog producer, veterinarian and feed mill — are equally responsible and subject to on-site inspection at any time. For the moment, FDA is exercising an educational probation for compliance. However, no time frame has been set for when that probation is over and strict enforcement of the rule begins.

“Ignorance is not an excuse for not complying,” Chris Rademacher, Iowa State University swine Extension veterinarian, told the Iowa Pork Congress.

Be inspection-ready

Inspection is inevitable. So, take proactive steps now. Do an excellent job of communicating and documenting from the beginning, Rademacher recommended.

Verzal echoed his advice. If a livestock producer is actively complying from the start and actually keeps the necessary paperwork, then it makes the inspection process smoother, explained Verzal.

He reminded hog farmers at the Iowa Pork Congress that “we are all in this together.” As an inspector, “I do not enjoy showing up in a situation that people are not prepared because it does not make my job any easier either,” said Verzal.

Verzal said it does not take long during an inspection to determine if the farm, feed distributor or veterinarian is cooperating with the regulation.

Veterinarian involvement and judicious use of antibiotics go hand in hand. A valid veterinarian client-patient relationship serves as a foundation of VFD rules. In Verzal’s opinion, the VCPR is the most important component because it provides the compliance investigator with an understanding of what is going on at the farm in real time.

In accordance with the regulation, a VCPR does not mean contact by phone or electronic communication solely. It requires timely visits to the farm and animal examinations. Verzal further explained that it becomes apparent through the discussion with the producer and veterinarian if the veterinarian routinely visits the farm and a solid VCPR is established.

Moreover, the writing is on the wall when the inspector reviews the records. Missing information and breaks in timelines will come to the forefront. “I always say the paperwork does not lie. There is going to be a gap, and the paperwork will show it,” he stressed.

The one thing that is running through the minds of producers, veterinarians and feed distributors is when an inspector comes to the premises, what are they going to look at and how will the inspection be handled?

Fundamentally, the feed containing VFD-listed medication can only be fed to animals in accordance with the veterinarian’s instructions, including conforming to the expiration date. As an inspector, it is Verzal’s job to make sure those instructions were followed on the farm by reviewing the documentation. While the FDA specifies the information required on the VFD, the additional special instruction can eliminate confusion and assist all parties in compliance.

“I cannot stress how important those special instructions are in that VFD. Although technically special instructions are not required, the lines of communications between the veterinarian and the producer and feed distributor are so vital,” explained Verzal. “We have to have an understanding of what is going on. If it is not written on that VFD, then the distributors are not necessarily going to know how to manufacture it, and producers do not understand how it is supposed to be fed. More importantly, does the veterinarian know how it is supposed to be fed and follow the label-use directions?”

While each state handles the inspections differently, Rademacher offered this basic list of questions pig farmers should expect to be asked during an inspection:

■ Did 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?

Regardless if the FDA inspector is stepping on your farm for education or inspection purposes, the VFD rule is in effect, and every livestock farm is subject to the regulation. If an inspector shows up and you, as a producer, have absolutely nothing documented, then the “nice” gloves may come off fast. “Knowing regulations and compliance, you should be on board. Don’t put yourself in a situation to be an example for everyone to follow,” said Rademacher.

Since the VFD process involves veterinarian, feed distributor and hog farmer, it is important to understand an inspection at the veterinarian office or the feed store could lead to inspection on your farm. Now is the time to double- and triple-check that your farm is inspection-ready at all times.

Once FDA is on the farm, everything falling under the FDA jurisdiction is fair game. At first, the on-farm inspection is only educational, according to the FDA. However, Paul Thomas, DVM at AMVC Management Services, said at some point producers are expected to be in full compliance and subject to FDA inspection. With the expansion of drugs requiring a VFD, the FDA will be conducting more on-farm audits. “We need to step up our game in other areas as well, not just with feed medications,” stressed Thomas.

Beyond the VFD realm, Thomas suggested taking a look at all medications used on the farm. As a veterinarian, he often sees areas of deficiency when it comes to medications. Thomas offered the following items to consider:

■ Are medications stored properly?

■ Do you have expired medications sitting on the shelf?

■ Are drugs being used only on the label?

■ Are all medication records complete including noting animals treated, drug used, amount used, route, initials and withdrawal times?

■ Are water medications also documented properly and mixed appropriately. Do your records reflect that prescription directions were followed?

■ Did you keep the records for the proper amount of time? For injectable medications, the records must be kept for one year and VFD documentation for two years.

On the whole, the two most essential things in surviving an inspection are communication and documentation. If the lines of communication are clear and each step is recorded, then any doubt the farm is not abiding by the regulations is diminished.

Information required on VFDs

                1. Veterinarian’s and client’s name, address and phone number

                2. Premises at which the animals specified in the VFD are located

                3. Date of VFD issuance

                4. VFD expiration date

                5. Name of the VFD drugs

                6. Species and production class of the animals to be fed the VFD feed

                7. Approximate number of animals to be fed by the expiration date of the VFD

                8. Indication for which the VFD is issued

                9. Drug level and duration of use

                10. Withdrawal time, any special instructions or cautions

                11. Number of reorders (refills) authorized — if permitted by the drug approval

                12. The statement: “Use of feed containing this veterinary feed directive drug in a manner other than as directed on the labeling (extra-label use) is                       not permitted”

                13. Affirmation of intent for combination VFD drugs

                14. Veterinarian’s electronic or written signature

 Information optional on VFDs

                1. More specific description of the location of treated animals (e.g., pen)

                2. Approximate age and weight range of the animals

                3. Other information the veterinarian deems appropriate to identify the animals specified in the VFD

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