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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter March/April 1998 Volume XIII, No II

The category of Veterinary Feed Directive (VFD) drugs was authorized under the Animal Drug Availability Act of 1996. VFD drugs offer an alternative to prescription status, allowing veterinarian supervision of these types of drugs while enabling the feed industry to maintain current channels of commercial feed distribution. The determination of whether a product for use in feed will be approved as a VFD drug or as an over-the-counter (OTC) drug is made by the FDA's Center for Veterinary Medicine (CVM). CVM policy is that all new antimicrobials for therapeutic use in feed will be approved only as VFD drugs.

Before a VFD drug may be used, the veterinarian, working in conformance with the veterinarian-client-patient relationship, examines and diagnoses disease conditions and determines whether the condition warrants administration of a VFD drug. If so, the veterinarian issues a signed Veterinary Feed Directive. These are available on a preprinted multi-part form. The veterinarian then provides the form to the producer who orders the VFD feed from a feed supplier. A lawful VFD form is required to distribute VFD feeds to a producer. The veterinarian who issues a VFD, the producer, and the person or company supplying the VFD feed must retain copies of the signed VFD form.

Feed manufacturers and distributors that ship a VFD feed to a retailer or distributor for inventory must receive and retain a copy of a written acknowledgment, stating that the VFD feed will be further distributed only in accordance with FDA requirements. In addition,VFD drugs and any article or feed manufactured from them must include the following cautionary statements: "Caution: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian=s professional practice."

It is important to keep in mind that VFDs are only for approved animal drugs. In addition, the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), prohibits the extralabel use of approved animal drugs in feed. This prohibition applies to VFD drugs as well as OTC drugs.