Livestock Management RANCHING Veterinary Feed Directive Rules:
Extra-Label Use Is Prohibited By Kristin Lewis Hawkins
A
CCORDING 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 spe- cifi cally 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 promo- tion and feed effi ciency, and bringing their remain- ing therapeutic uses in feed under the supervision of licensed veterinarians. The Veterinary Feed Directive (VFD) fi nal 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 profes- sional supervision of a licensed veterinarian. In this process, a veterinarian, operating within the confi nes 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 specifi ed by regulation. Extra-label use of a VFD drug (or any drug) in or on
animal feed is strictly prohibited. FDA regulations defi ne 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 condi- tion other than specifi ed 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 cau- tionary statements necessary for use of the drug in conformance with the approval;
• number of reorders (refills) authorized, if permit- ted 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 affi rmation 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.
52 The Cattleman June 2016
thecattlemanmagazine.com
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