In 1996, Congress enacted the Animal Drug Availability Act (ADAA) for the approval and marketing of new animal drugs and medicated feeds. Before that time, drugs used in the animal industry were either over-the-counter or prescription-based. The ADAA created a new category of products called veterinary feed directive drugs (VFD drugs). These drugs were intended for use in or on animal feed (including water) and were obtained by the producer without a prescription. The VFD drug category was created to avoid state pharmacy laws for prescription drugs, which were not applicable to medicated feed. As of October 2015, new VFD regulations will go into effect for animal drugs already labeled as VFD drugs. The new regulations will require the professional supervision of a licensed veterinarian if the VFD drug is deemed medically important. The following provides background information and important points to prepare livestock producers for the upcoming regulation changes.
In 2013, the Food and Drug Administration Center for Veterinary Medicine (CVM) published a guidance document, which called on animal drug companies to voluntarily stop labeling drugs that are medically important as drugs that can be used to promote animal growth. The purpose of this request was to decrease the incidence of antibiotic resistance in both human and animal medicine. The guidance document also requested that animal drug companies change the labeling of their products to require a written VFD order by a veterinarian. The CVM felt that putting these drugs under veterinary control would guarantee that they would be used only when necessary for assuring animal health. All of the animal drug companies contacted committed in writing to participate in the new drug marketing strategy. The VFD final rule was published in the summer of 2015. Animal drug companies have until January 2016 to relabel their VFD drugs.
The most important provision of the VFD final rule is the requirement of veterinarians to issue all VFD orders within the context of a veterinarian-client-patient relationship (VCPR). A valid VCPR is the basis of veterinary supervision and provides a legal agreement between the veterinarian and livestock producer. Only veterinarians actively licensed and in good standing in Arkansas can write VFD orders for production facilities in Arkansas. In order for a veterinarian to issue a VFD order, he/she must do the following:
- The veterinarian takes responsibility for the health of the animals and the client agrees to follow the veterinarians’ instructions.
- The veterinarian knows the animals enough to make a preliminary diagnosis of the medical condition for which they will be treated. This means the veterinarian has either examined the animals or has had timely visits to the operation where the animals are managed (at least one visit per year to be valid in Arkansas).
- The veterinarian is readily available for follow-up evaluation or has arranged continuing care and treatment with another veterinarian or emergency service.
- The veterinarian provides oversight of treatment, compliance and outcome.
- The veterinarian maintains records of treatment (3 years in Arkansas).
Along with a valid VCPR, veterinarians must become familiar with the labeled use of VFD drugs in the feed. The VFD drug can only be used to treat diseases indicated for a specified duration of time on the label. To do otherwise is called “extralabel use”, which is not allowable under the VFD final rule. A VFD order must contain all of the following:
- Veterinarian’s name, address and telephone number
- Client’s name, business or home address and telephone number
- Premises at which the animals specified in the VFD are located
- Date of VFD issuance with an expiration date
- Name of the VFD drug(s)
- Species and production class of animals to be fed the VFD feed
- Approximate number of animals to be fed the VFD feed
- Indication for which the VFD is used
- Level of VFD drug in the feed and duration of use
- Withdrawal time, special instructions and cautionary statements necessary for use of the drug in conformance with the approval
- Number of reorders (refills) authorized, if permitted by the drug approval, conditional approval or index listing
- Addition of the statement “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use), is not permitted”
- An affirmation of intent for combination VFD drugs as described in 21 CFR 558.6(b)(6)
- Veterinarians electronic or written signature
To find a veterinarian in your area, please contact your county extension agent. To find out more information on the VFD along with fact sheets and the list of medically important drugs used in animal medicine, go to: