The final regulation implementing the veterinary feed directive went into effect Jan 8, following the FDA's publication of the rule in the Dec 8, 2000 Federal Register.
A veterinary feed directive is a written statement authorizing a client to obtain and use animal feed containing a VFD drug to treat their animals, in accordance with FDA-approved directions. VFD drugs are those the FDA has approved for use in animal feeds under the supervision of a licensed veterinarian.
A veterinarian may issue a VFD only if a valid veterinarian-client-patient relationship exists. Extralabel use of a VFD drug is not permitted.
The new regulation specifies the requirements for distribution and use of VFD drugs and animal feed containing them.
The implementing regulations are tailored to the unique circumstances relating to the distribution of animal feeds containing VFD drugs. The rule helps protect the public health while enabling animal producers to obtain and use needed drugs as efficiently and cost-effectively as possible. Statutory controls on the distribution and use of VFD drugs are, however, similar to those for prescription animal drugs.
Prior to 1996 two options were available for regulating the distribution of animal drugs—over-the-counter and prescription. All medicated feeds were available OTC. The FDA determined, however, that certain new animal drugs vital to animal health should be approved for use in animal feed, under a veterinarian's order and professional supervision.
Regulation of animal drugs for use in medicated feeds under traditional prescription systems would be unworkable, because the prescription legend invokes the application of state pharmacy laws, burdening pharmacy boards and imposing unrealistic costs on feed manufacturers.
In 1996, Congress enacted legislation amending the Federal Food, Drug, and Cosmetic Act to facilitate the approval and marketing of new animal drugs and medicated feed. This law, the Animal Drug Availability Act of 1996, established a new class of restricted feed-use drugs that may be distributed without invoking state pharmacy laws.
The legislation was enacted after considerable deliberation between Congress and the Coalition on Animal Health, and support from the coalition and state regulatory agencies. The AVMA is a member of the coalition, which represents major sectors of animal agriculture.
To date the FDA has approved only one VFD drug—tilmicosin, an antimicrobial administered via animal feed to control swine respiratory diseases.
View the final regulation at www.fda.gov/cvm/index/updates/vfdfinal.htm, or obtain a copy by sending a self-addressed, stamped envelope to the Communications Staff, FDA-CVM, HFV-12, 7500 Standish Pl, Rockville, MD 20855; phone, (301) 594-1755. More information about the final rule is available from George Graber, FDA-CVM, HFV-220, 7500 Standish Pl, Rockville, MD 20855; phone, (301) 827-6651; firstname.lastname@example.org.
See the side bar on page 328 for specific conditions that veterinarians must meet when issuing a VFD.