December 12, 2000
FDA PUBLISHES FINAL VETERINARY FEED DIRECTIVE RULE
In the December 8, 2000, Federal Register, the FDA published the final regulation to implement the Veterinary Feed Directive (VFD) drugs section of the Animal Drug Availability Act of 1996 (ADAA). This new regulation states the requirements for distribution and use of a VFD drug and animal feed containing a VFD drug. A VFD drug is a drug approved by FDA for use in animal feeds which is limited to use under the professional supervision of a licensed veterinarian. No extra-label use of a VFD drug is permitted.
A veterinary feed directive is a written statement that authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed containing a VFD drug to treat their animals only in accordance with the FDA-approved directions for use. A veterinarian may issue a VFD only if a valid veterinarian-client-patient relationship exists, as defined in Title 21, Part 530.3(i) of the Code of Federal Regulations. The information needed on a VFD is stated in the final rule.
Although statutory controls on the distribution and use of VFD drugs are similar to those for prescription animal drugs, the implementing VFD regulations are tailored to the unique circumstances relating to the distribution of animal feeds containing a VFD drug. This rule helps ensure the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and cost-effectively as possible.
A copy of the final regulation published in the Federal Register is available on CVM's Internet Home Page. A copy of this rule may also be obtained by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Please include a self-addressed adhesive label to assist in processing your request.
Additional information on the final rule may be found in the December 8, 2000, Federal Register, and from Zoe Gill, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6667.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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