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U.S. Department of Health and Human Services

Animal & Veterinary

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Recent Changes to Veterinary Feed Directive Guidance Highlighted

by Walt D. Osborne, M.S., J.D., Assistant Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No III

On June 26, 2007, the Food and Drug Administration’s Center for Veterinary Medicine replaced “Guidance for Industry #120 – Veterinary Feed Directive Regulation” with an updated version to reflect some recent clarifications and changes.

The new version of the guidance can be found on FDA’s Web site.

Readers are reminded that, by regulation (21 CFR 558.3(b)(7)), a veterinary feed directive (VFD) is a written statement issued by a licensed veterinarian that orders the use of a VFD drug in or on an animal feed. The VFD authorizes the animal owner or caretaker to obtain and use the VFD drug in the animal feed in accordance with FDA’s approved directions for use.

A VFD drug refers to a new and specific category of drugs, and a licensed veterinarian may write a VFD order only for drugs approved by CVM in that category. To date, two drugs have been approved under this category:

  1. tilmicosin for use in the control of swine respiratory diseases; and
  2. florfenicol for use in the control of swine respiratory diseases and for control of certain bacterial diseases in aquaculture.

The revised guidance also explains the term “appropriately licensed veterinarian” as it pertains to the VFD regulation. Specifically, the term refers to a veterinarian who has a valid license to practice veterinary medicine in the State in which the animals are located and that he/she is treating within the parameters of a valid veterinarian-client-patient relationship.

Also covered in the revised guidance document is CVM’s position on VFD orders that are distributed by means of the Internet. The Center considers the Internet an acceptable electronic means of transmitting VFD orders, provided that the system is shown to be in compliance with FDA’s regulations governing electronic records and signatures (21 CFR Part 11). The other requirement is that a feed distributor receive an original, signed VFD order within 5 working days of receipt of the VFD order by means of the Internet.

Lastly, the contact information has been updated in the revised guidance, and readers are encouraged to visit the Web site above to obtain that information. All other provisions of Guidance #120, dated March 1, 2001, remain in effect and are unchanged.