Amendments to the Veterinary Feed Directive (VFD), a federal regulation from the FDA, will provide a much more complicated process of which producers, veterinarians and feed suppliers need to be aware.
What is the VFD?
Prior to 1996, when the VFD was first enacted, there were two categories of animal drugs recognized by the FDA: over-the-counter and prescription. No prescriptions were required for animal feeds containing antibiotics because it was viewed as impractical. Instead, medicated feeds were considered to be over-the-counter.
In 1996, a third category, VFD drugs, was added to the list. Significant amendments, known as the second VFD rule, were published in June 2015. The VFD concept is an attempt to balance the need for antibiotic use to ensure animal health and the concern about overuse of antibiotics in the livestock industry.
The goal of the revised VFD rules is to ensure antimicrobial drugs will be used for therapeutic, rather than production, purposes and that such use will be supervised by licensed veterinarians.
The amendments essentially made three significant changes. First, drug sponsors are to modify labeling for certain products by withdrawing “production uses” such as increased rate of weight gain and allow only therapeutic uses.
Second, medicated feed additives designated to be “medically important,” previously considered over-the-counter, will now be categorized as VFD drugs, to which these rules apply. Third, the rules require a VFD form to be completed by a veterinarian before any VFD drugs (even those in medicated feeds) may be dispensed to a producer.
What drugs are affected?
The VFD amendments affect only those antimicrobials that are “medically important” and will be administered in feed or water. Let’s look at each of these elements.
An antimicrobial is a substance of a natural, semi-synthetic or synthetic origin that kills or inhibits growth of micro-organisms but causes little or no damage to the host. Not all antibiotics are antimicrobials. Ivermectin, for example, is not an antimicrobial, and these rules do not apply to its use.
The definition of “medically important” includes all drugs considered important for therapeutic use in humans. Thus, in order for the VFD rules to apply, a drug must be both an antimicrobial and “medically important.”
A complete list of affected drugs may be found on the FDA’s website (List of affected applications).
Finally, the rules apply only to drugs administered in feeds. Drugs used by injection, for example, are not affected. For example, if tetracycline is to be used in a feed mixture, the VFD rules would apply, but if the same drug was to be injected, the rules would not be applicable.
What is the process to obtain medicated feed?
First, in order to purchase any VFD drug or feed containing these drugs, a producer will need to consult with a veterinarian with whom a “veterinary-client-patient relationship” exists.
This essentially requires the veterinarian to engage with the client to make clinical judgments about patient health, to have sufficient knowledge of the patient by virtue of examination of the animal or facilities and provide any follow-up care. Additionally, for producers who own cattle in different states, a VFD form must be obtained from a veterinarian licensed in the state where the cattle are located.
Second, that veterinarian will complete a VFD form specifying the medication that may be obtained.
The VFD form is not required to be in any specific format but must include a litany of information including the veterinarian and producer’s contact information, premises where animals are located, an expiration date of the VFD approval (cannot exceed six months), the name of the allowed drugs, the number of animals, indication for use of the drug, the level of drug permitted in the feed and the withdrawal time.
Importantly, producers may not make extra-label drug use, meaning the drug may be used only in accordance with the approved labeling. Remember, drug sponsors will be modifying labels for these drugs by removing production uses.
This means using antibiotics for production uses may no longer be allowed, as doing so would violate the labeling requirement once these changes are made by the sponsors.
A veterinarian may not write a VFD for an extra-label use. For example, a drug labeled for sheep may not be used in cattle and, therefore, a veterinarian may not write a VFD for a sheep drug for a cattle producer.
Similarly, a veterinarian may not write a VFD for production enhancement purpose for a drug that is allowed only for therapeutic uses based on the label.
Third, the producer will take the completed form to the feed supplier to obtain the feed the veterinarian has approved. The producer can then use the product but must do so in accordance with the requirements imposed on the label.
Further, each VFD form will include an expiration date, which constitutes the last day the product may be fed to the animals, regardless of the purchase date. The expiration date will comply with any labeling requirements but, in any case, will not exceed six months.
Finally, copies of all VFD forms must be retained by all parties – the veterinarian, producer and feed supplier – for two years. The veterinarian is to keep the original document.
When does this begin?
For all medication previously categorized as VFD drugs, the new rules became effective as of Oct. 15, 2015. For all formerly categorized as over-the-counter which will now be considered VFD, the target implementation date is Jan. 1, 2017. 
PHOTO: Restrictions under the new VFD only apply to antibiotics delivered in feed and water, and do not apply to antibiotics administered by injection. Photo by Progressive Cattleman staff.
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Tiffany Dowell Lashmet
- Assistant Professor and Extension Specialist
- Agricultural Law
- Texas A&M AgriLife Extension Service
- Email Tiffany Dowell Lashmet
