Veterinary Feed Directive Rules | Extra-Label Use Is Prohibited

According to the Food and Drug Administration (FDA), anyone who adds medication to the feed for food-producing animals is subject to the Federal Food, Drug and Cosmetic Act. Just as each label claim for a new medicine must be approved, a medicine must be specifically approved for administration in animal feed. When this application is approved, a notice is published in the Federal Register. The medicated feed must be labeled in accordance with the approved labeling.

Over the past several years, the FDA has taken important steps toward fundamental change in how medically important antibiotics can be legally used in feed or water for food-producing animals. Now, the agency is moving to eliminate the use of such drugs for production purposes such as for growth promotion and feed efficiency, and bringing their remaining therapeutic uses in feed under the supervision of licensed veterinarians. The Veterinary Feed Directive (VFD) final rule is an important part of the agency’s overall strategy to ensure the judicious use of medically important antimicrobials in food-producing animals.

A drug approved for use in or on animal feed as a VFD drug is limited to use only under the professional supervision of a licensed veterinarian. In this process, a veterinarian, operating within the confines of a valid veterinarian-client-patient relationship (VCPR), examines and diagnoses animal conditions and determines whether a condition warrants the use of a VFD drug. If it does, the veterinarian will issue a signed VFD order containing information specified by regulation.

Extra-label use of a VFD drug (or any drug) in or on animal feed is strictly prohibited. FDA regulations define extra-label use as actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, such as feeding animals VFD feed for longer than the time specified on the label; feeding VFD feed formulated with a drug level that is different than what is specified on the label; feeding VFD feed to an animal species other than what is specified on the label; or feeding an animal VFD feed for a condition other than specified on the label.

Information on a lawful VFD order will include:

• name of premises where the animals specified in the VFD are located;
• date of VFD issuance;
• expiration date of the VFD;
• 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 by the expiration date of the VFD;
• indication for which the VFD is issued;
• 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;
• statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extra-label use), is not permitted”;
• an affirmation of intent for combination VFD drugs as described in 21 CFR 558.6(b)(6).

Talk to your veterinarian about any situations that may arise, such as adding new individuals to a group already being medicated or withdrawal times. Clear communication with your veterinarian will go a long way to preventing time delays, anxiety and headaches when it comes time to treat animals.

“Veterinary Feed Directive Rules | Extra-Label Use Is Prohibited” is from the June 2016 issue of The Cattleman magazine.