According to the United States Food and Drug Administration (FDA) when a new animal drug application is submitted, the drug is evaluated for safety and effectiveness. As part of the review process, they determine whether the drug will be an over-the-counter (OTC) drug, a prescription (Rx) drug, or a Veterinary Feed Directive (VFD) drug that is limited to use in or on animal feed. The VFD was created in 1996; it is essentially a license for a producer to use a medication (VFD drug) in the feed of food producing animals.
The VFD was established in an effort to follow the judicious use of antibiotics fed to food animals. Specifically, the FDA is decreasing the amount of antibiotics used in food animal production that have importance in human medicine: medically important antibiotics. The goal is to decrease antibiotic resistance. To fulfill the FDA’s judicious use of antibiotics, the scope of antibiotic use in animal feed has been narrowed for use in treatment or imminent prevention of disease. The FDA will no longer support using medicated feed to either improve the rate of gain or for feed efficiency. As of January 1, 2017, these products have either been pulled from the market or relabeled solely for their therapeutic or preventative uses. All of the remaining OTC medicated feeds have now moved to require a VFD.
The VFD is similar to a prescription, yet carries a bit more of a relationship and consultation period with a veterinarian to acquire. The FDA avoided the rules and regulations associated with “pharmaceutical dispensing of prescriptions” when reviewing the status change from OTC to VFD. Why not a prescription? Prescriptions would require a veterinarian or a pharmacist to physically dispense each medication as prescribed at the feed mill sites, similar to a human pharmacy. This would prove to be inconvenient and costly. Changing from OTC to VFD will maintain delivery consistencies by allowing registered feed mills to continue to store, handle and distribute medicated feeds.
The veterinarian issuing the VFD order must have extensive knowledge of the feeding operation and a valid veterinarian-client-patient relationship (VCPR). This relationship is meant to involve all parties in a dialogue to improve the consulting process and to limit antibiotics in livestock feed to therapeutic use for animal health. The FDA indicates that the VCPR must address the concepts that the veterinarian (1) engage with the client to assume responsibility for making clinical judgments about patient health, (2) have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where patient is managed, and (3) provide for any necessary follow-up evaluation or care. Although, the VCPR definition will vary a little from state to state.
Producers need to have a conversation with their veterinarians to discuss antibiotic use on or in feed or water at each production facility. Producers are the most familiar with the typical diseases common to the different groups of animals as they move through their production system. Many current protocols will remain unchanged and simply need a VFD to continue to use approved products. New treatment and prevention protocols can also be established. Other management tools can be discussed as well to limit antibiotic use in animals. A strategic plan can prepare the producer to combat historical disease incidence in the herd. Having VFD orders in place for the therapeutic and preventative needs of the animals will accelerate initiation of treatment and improve clinical outcomes. Waiting to contact your veterinarian for a VFD once a typical disease outbreak occurs on your production site can delay necessary medical treatment and prevention. Discuss probable disease outbreaks with your herd veterinarian and arrange for quick mobilization of your VFD orders.
The feed directive process simply starts with establishing a VCPR; the need for medical treatment or prevention is determined; the veterinarian produces a VFD order that is sent to the distributor (feed mill, or dealer); the feed distributor issues the feed to the producer; the producer feeds the product according to the labeled directions. Another important feature of the VFD rule is documentation by the producer. Records must be kept of where and how each batch of medicated feed was distributed. The producer must also keep the VFD order for two years. The statements above do not constitute any legal advice on the new VFD rule and should be considered informal communication.
For more information, the following links are related to this article:
FDA's Frequently Asked VFD Questions
FDA Video VFD Rule and Feed Use
FDA Video: VFD for the Food Animal Producer
About the Author
Dr. Colleen Lewis is a 1996 graduate of Kansas State University, College of Veterinary Medicine. Her career has taken her to many places as a practice owner, consultant, embryologist, and mentor. She enjoys mixed animal practice, teaching, traveling, farming and high school sports with her husband, Andrew and their three boys.
