Teres Lambert

If you’re a bit – or even a lot – confused about the new Veterinary Feed Directive (VFD) rule that took effect Oct. 1, 2015, and the new feed and water antibiotic labels that will be phased in by December 2016, you are not alone. That said, the confusion can be lessened.

Per Creighton Abrams: “When eating an elephant, take one bite at a time.”

The “elephant” in this case is the new VFD.

THE ‘ELEPHANT’

Pre-VFD, the U.S. Food and Drug Administration recognized two categories of animal drugs: over-the-counter and prescription. Because medicated feeds fell into the over-thecounter category, producers could purchase medicated feed at a feed store and give it to their animals.

In 1996, the FDA added a third category of animal drugs: VFD drugs. Drugs that fall into the VFD drug category are drugs intended for use in or on animal feed that is limited to use under the professional supervision of a licensed veterinarian.

With the government’s Second VFD Rule, published in June 2015, the swine industry and drug sponsors are required to rethink and change their way of conducting business.

Due to the Second VFD Rule, medicated feed additives designated as medically important are now classified as VFD drugs and are subject to several new rules, including but not limited to:

• Medicated feed additives that include VFD drugs, and other VFD drugs, can no longer be sold over-the-counter.
• Medicated feed additives that include VFD drugs, and other VFD drugs, can only be used for therapeutic purposes – and not for production purposes such as growth promotion and feed efficiency.
• Medicated feed additives that include VFD drugs, and other VFD drugs, require a producer to obtain a VFD, a written – nonverbal – statement, from the producer’s veterinarian that authorizes the use of a VFD drug or combination VFD drug in or on an animal feed.

A producer cannot just go out and purchase VFD drugs, including medicated feeds containing VFD drugs. The Second VFD Rule mandates that a producer consult his/ her veterinarian with whom he/she has a veterinary-clientpatient relationship. The veterinarian must have worked with the producer (the client), can make clinical judgments about patient (animal/s) health, has sufficient knowledge of the patient by examining the animal or facilities and can provide follow-up care. Plus, the veterinarian must be licensed in the producer’s state where the producer’s farm is located.

While the VFD statement that the producer must obtain from his/her veterinarian does not have a specific format, it must include 16 key pieces of information:

1. The specific medication to be obtained
2. Name and contact information for the veterinarian
3. Name and contact information for the producer
4. Location of the animals
5. Species of animals to receive the feed
6. Approximate number of animals to receive the feed
7. Indication for use of the drug
8. VFD issuance date
9. Expiration date of the VFD approval
10. Name of the allowed drug
11. Level of drug permitted in the feed
12. Duration of use
13. Number of refills
14. Withdrawal time
15. Special instructions and cautionary statements
16. The veterinarian’s electronic or written signature

After a producer has obtained a VFD order from his/her veterinarian, the written document must be sent – physically or electronically – to a feed manufacturer or supplier to get the VFD feed. Producers who manufacture their own feed must have a VFD from which the medicated VFD feed is manufacture.

A producer and the producer’s veterinarian must maintain all VFD records for two years. The same two-year requirement applies to feed distributors.

MORE BITE-SIZED PIECES

A veterinarian may not write a VFD for an extra-label use, and a distributor cannot dispense the drug for extra-label use.

The ruling affects only feed-grade antimicrobials, those that are medically important and administered in feed or water. A list of affected drugs is available online at the FDA website: http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials

Antibiotics used exclusively in animals to treat illness and promote growth will not be affected by the VFD label. These drugs include Ionophores, Polypeptides, Carbadox, Bambermycin and Pleuromutilin.

Per the Second VFD Rule, drug sponsors must modify labeling for certain products, removing any wording related to production such as increased rate of weight gain. Labeling can only address therapeutic uses.

While the procedure for transitioning from the old to the new labels is still being worked out, producers will need to have a VFD from a licensed veterinarian in place for feeding VFD antibiotics come Jan. 1, 2017.

Veterinarians and producers can use an electronic system to standardize and store VFD documents, helping avoid inaccuracies and minimize the time required to write and use a VFD.

Dr. Gerald Stokka, associate professor of animal stewardship, North Dakota State University, says going the electronic route with VFDs is a “great way of tackling the FDA’s requirements.” “Electronic copies are very handy, functional and efficient,” Stokka states. “When I have the option of electronic or hard copy, I opt for electronic. While there is a learning curve at the beginning, people can be easily trained. Electronic copies are just so darn time efficient.

“I see the day when every veterinarian, producer and feed mill goes the electronic route. While a change right now may take some out of their comfort zone, once they make the change and see how simple business continuity can be, they’ll be glad they went electronic to meet the FDA’s VFD requirements.”

NEXT STEPS

A key step to prepare for Jan. 1, 2017 when compliance will be a must include contacting a veterinarian, having him/her visit your operation and forming a VCPR (veterinarian-clientpatient relationship) far in advance of Jan. 1.

A second step is to investigate a digital solution that will allow you to seamlessly communicate with your veterinarian and other entities as well as digitally store all related documents for two years as mandated by the FDA’s new ruling.

Veterinarians and producers using the FeedLINK® electronic VFD System are quick to point out that the proven electronic system not only streamlines communication and animal treatment, but it also gives them a clear view of all labeled and approved drugs. The paperless route also means VFDs cannot go missing; eVFDs can be located quickly and more efficiently than hard copies and times of treatment communicated in real time.

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- Teres Lambert
Teres Lambert has over 40 years of experience in the animal agriculture industry. Now retired, she continues to write about livestock and issues relevant to animal ag. Lambert received her bachelor’s and master’s degrees from Kansas State University, and now resides in Windsor, Colorado.

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