In 1996, Congress passed the Animal Drug Availability Act (ADAA). The ADAA established a new regulatory category for distributing certain new animal drugs for use in or on animal feed, the Veterinary Feed Directive (VFD). The law allows VFD drugs to be administered in animal feed under a veterinarian's order and professional supervision. Now producers can obtain and use critically needed drugs while the Food and Drug Administration (FDA) ensures the protection of public health. Examples of new animal drugs approved so far as VFD drugs include Aquaflor® (florifenicol), for use in catfish and freshwater-raised salmonid fish, and Pulmotil® 90 (tilmicosin), for use in pigs.
What are VFD Drugs?
- are drugs that FDA approved for use in animal feeds, and
- are used under veterinarian supervision and issued under written veterinary feed directive orders.
Extra-label use (i.e., use of VFD feed for unapproved indications or at unapproved doses), is strictly prohibited.
How Can I Get a VFD Order for a VFD drug?
- Contact your veterinarian.
- Your veterinarian will determine if your animals need treatment with a VFD drug.
- If a VFD drug is needed, your veterinarian will provide the VFD order to you or directly to the feed mill or feed distributor.
In situations where you believe further treatment is needed and the VFD order specifies no refills, or, when you need to refill your VFD drug through another feed mill or feed distributor, you must ask your veterinarian to issue a new VFD order.
Telephone orders are not allowed.
Basic Producer Responsibilities
As a producer, your VFD drug responsibilities include:
- contacting your veterinarian to diagnose and treat your animals,
- following your veterinarian's recommendations,
- administering the VFD medicated feed to your animals according to the directions on the VFD order,
- keeping copies of your VFD orders for at least two years, and
- providing your VFD order copies for FDA inspectors to copy and review, when requested.
Under Title 21, Part 558.6(a)(3), of the Code of Federal Regulations, a veterinarian "must complete the VFD in writing and sign it." Incomplete or unsigned VFD orders are invalid, and the feed mill or another distributor will not fill them. They may refuse to issue the feed and may or may not contact your veterinarian to get a corrected order. Your veterinarian is responsible for providing an accurate and complete VFD order to the feed mill or to another distributor.
This summary highlights the main concepts regarding VFD drugs. More in-depth information can be found in Guidance for Industry #120: Veterinary Feed Directive Regulation Questions and Answers.
For additional information, contact the FDA Center for Veterinary Medicine's (CVM) Communications Staff by phone at 240-276-9300 or through the CVM Home Page at http://www.fda.gov/AnimalVeterinary.
FDA thanks the following American Veterinary Medical Association groups for their assistance in reviewing this summary: Aquatic Veterinary Medicine Committee, Council on Biologic and Therapeutic Agents, Clinical Practitioners Advisory Committee, and Council on Public Health and Regulatory Veterinary Medicine.