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U.S. Department of Health and Human Services

Animal & Veterinary

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by Ron Scherzberg
FDA Veterinarian Newsletter September/October 1999 Volume XIV, No V

A new category of drugs, veterinary feed directive (VFD) drugs, has been created to allow drugs to be administered in animal feed, but only under the order of a licensed veterinarian. Proposed regulations covering the ordering of use and the distribution of VFD feeds (medicated feeds containing VFD drugs) were published in the Federal Register of July 2, 1999. The Animal Drug Availability Act of 1996 (ADAA) amended the FD&C Act to establish the VFD drug category. Thus far, one VFD drug, tilmicosin, has been approved for use in treating swine respiratory disease.

In the past, drugs used in animal feeds were approved as OTC drugs. While the FD&C Act did not prohibit approval of prescription drugs for use in animal feeds, such approvals were impractical because some states' pharmacy laws required a licensed pharmacist on the premises to dispense the drugs, while other states prohibited feed manufacturers from possessing and dispensing prescription drugs. The VFD solves this problem by eliminating the pharmacist involvement and allowing the veterinarian to order the use of VFD drugs in feed. This participation by the veterinarian satisfies FDA’s concerns that the drugs be used only in appropriate circumstances and under greater control than OTC drugs.

The VFD process is straightforward in practice. A veterinarian, operating within the confines of a veterinarian-client-patient relationship, examines and diagnoses animal conditions and determines whether a condition warrants use of a VFD drug. If it does, the veterinarian will issue a signed VFD containing information specified by the drug’s approval regulation. The veterinarian keeps a copy of the form and provides the completed and signed original and a copy to the client. The client keeps the copy and gives the original to the feed manufacturer which authorizes the VFD feed to be shipped to his animal feeding operation. While not specifically required, we believe the drug manufacturer will provide preprinted "fill in the blank" triplicate VFD forms to the veterinary profession for the sake of efficiency and accuracy. This has been done with tilmicosin, the one approved VFD drug.

The ADAA has a statutory requirement that anyone intending to distribute VFD feeds notify CVM prior to beginning. A distributor means the VFD feed manufacturer or anyone in the distribution chain who ultimately supplies VFD feed to the animal producer. This could include the veterinarian if he is the source of VFD feed. A VFD feed may not be distributed to a client without a signed VFD. However, VFD feed may be sent down the distribution chain if the consignee provides the distributor with a signed "acknowledgment letter affirming that it will only ship the VFD feed to a VFD holder or to another distributor who supplies a similar acknowledgment letter. Feed manufacturers or any distributor may stockpile VFD feeds in anticipation of orders.

We recognize that there are instances when direct contact among the veterinarian, client and feed distributor is not practical. To counter this problem and facilitate rapid movement of VFD feeds, we are proposing to allow facsimile transmission of the VFD. While not proposed, we are also noting that telephone and

e-mail are other avenues to consider for transmission of the VFD. We have concerns about the clarity, completeness and security of these latter two forms of VFD distribution. For this reason, we are inviting comments on the use of e-mail and phone transmission to our final rule, and on how to ensure such orders will be clear, complete and secure.

Another area of concern is the length of time a VFD may be valid (expiration date) and the number of refills or reorders that may be allowed. For example, if a hog operation historically has a disease outbreak in the post-weaning stage, does the veterinarian need to write a VFD each time a group of pigs is weaned? We think not, however, CVM would not allow an open-ended VFD. Limits must be placed on length of time a VFD is valid and/or amount of animals that can be treated. Again, the proposed rule invites comments on this issue by September 30, 1999, to assist CVM in developing the final rule.

Extra-label use of VFD drugs or VFD feeds is prohibited, that is, the VFD drug may be used only as specified in the drug’s published regulation.