We’re now counting the days until the FDA’s new veterinary feed directive (VFD) rules take full effect on January 1. Many producers, and even veterinarians, remain unclear on the details and procedures they will need to follow to continue using medicated feeds for prevention, control and treatment of disease in their herds.
During the recent Academy of Veterinary Consultants (AVC) winter conference, a panel of veterinarians close to the issue discussed common questions and practical planning for compliance with the new VFD rules. The panel included Mike Apley, DVM, PhD, Kansas State University, Marilyn Corbin, DVM, PhD, Zoetis and Guy Hufstedler, PhD, Elanco Animal Health.
The expanded VFD rule ends over-the-counter (OTC) purchases of medically important feed-grade antibiotics, placing their purchase and use under the direct oversight of veterinarians.
Medically important antibiotics currently used in cattle feeds for therapeutic purposes that will require new labels under the VFD rule include chlortetracycline, chlortetracycline plus sulfamethazine, neomycin plus oxytetracycline, oxytetracycline, tylosin and virginiamycin.
Off-label use of medicated feeds is illegal, so the VFD order, which specifies the animals to be treated, the VFD drug(s) to be used, dosage, duration of use and reasons for use, must conform with product labels. Producers, working with their veterinarians, must ensure their on-farm use of VFD drugs conforms to the VFD order and the product label.
During the discussion, several action items became clear. These include:
· A valid veterinarian-client-patient relationship (VCPR) is required by law for a veterinarian to provide a VFD order. The specific definition of a VCPR can vary between states, but the veterinarian must have first-hand familiarity with the client and the cattle involved. If you have clients or know producers with whom you do not have a relationship that meets the definition of a VCPR, make contact and explain the requirements. .
· Help your clients take an inventory of medicated feeds they have on hand. They can still use VFD products with older labels after January 1, but they need to work with you to secure a VFD order to use those products purchased prior to implementation of the new rules.
· Help clients plan their future inventory management. If they purchase a VFD feed and do not use it all during the period allowed under the VFD order (six months maximum), they can still use the remaining product. They do, however, need to obtain a new VFD order to legally use that left-over VFD feed.
· Determine and implement a filing system for documentation and storage of VFD orders and related records, either electronically or in paper files, and help your clients do the same. Producers, veterinarians and feed distributors need to retain VFD records for two years.
· Develop a set of standard operating procedures (SOPs) to follow in case of an FDA inspection of your VFD records, or your client’s records. Collaborate with your clients to help them understand their rights and responsibilities for providing VFD documentation. Veterinarians discussing this issue at the AVC conference agreed that an FDA inspection should be simple and painless if the veterinarian or producer can quickly supply the requested documents.
Enforcement: Operate in good faith
FDA officials have indicated their enforcement activities will focus on education during the initial months as the new rules are implemented. The panel members, all of whom have worked closely with the FDA on the issue, agreed that, while mistakes will be made, producers who operate in good faith and do what they can to comply with the law likely will see warnings and guidance. If, however, producers intentionally circumvent the law, the FDA and society overall will see a need for more stringent enforcement.
Apley specifically warned against two ways producers might try to “game the system,” both of which are illegal and likely to bring enforcement and possible penalties. These are:
· Acquiring VFD orders for products labeled as “hand-fed” feeds, then using those feeds in a “free-choice” manner. The hand-fed label specifies that a fixed amount must be fed every day. You may feed a free-choice feed in a hand-fed manner (daily), but feeding a hand-fed feed in a free-choice manner is an off-label use and is illegal.
· Using Type A medicated articles used to circumvent the VFD process. Type A medicated articles are the most concentrated form of feed-grade antibiotics, which are mixed with other ingredients to create Type B or C medicated feeds. A person may purchase, possess, and sell a Category 1 Type A medicated article without registering as a VFD distributor, having a feed mill license, or having a VFD. However, feeding that to animals will require a VFD. As for Category 2 Type A medicated articles, only a licensed feed mill can purchase them.
The bottom line: If your clients see a need to use a medicated feed, work with them to determine the best products, dosage and duration of use to address the specific health problem. And after January 1, obtain and file a VFD order.
For more information on the VFD rule and related regulations, visit the FDA’s Veterinary Feed Directive website.
For more information on AVC, and access to recordings of entire presentations at AVC conferences, visit AVC-beef.org.
Next up this week: Filling out the VFD form.