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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS > SUBPART A—General Provisions (§558.3 to §558.15) > 558.6—Veterinary feed directive drugs.

CFR

558.6—Veterinary feed directive drugs.

(a) What conditions must I meet if I am a veterinarian issuing a veterinary feed directive (VFD)?
(1) You must be appropriately licensed.
(2) You must issue a VFD only within the confines of a valid veterinarian-client-patient relationship (see definition at § 530.3(i) of this chapter ).
(3) You must complete the VFD in writing and sign it or it will be invalid.
(4) You must include all of the following information in the VFD or it will be invalid:
(i) You and your client's name, address and telephone and, if the VFD is faxed, facsimile number.
(ii) Identification and number of animals to be treated/fed the medicated feed, including identification of the species of animals, and the location of the animals.
(iii) Date of treatment, and, if different, date of prescribing the VFD drug.
(iv) Approved or index listed indications for use.
(v) Name of the animal drug.
(vi) Level of animal drug in the feed, and the amount of feed required to treat the animals in paragraph (a)(4)(ii) of this section.
(vii) Feeding instructions with the withdrawal time.
(viii) Any special instructions and cautionary statements necessary for use of the drug in conformance with the approval.
(ix) Expiration date of the VFD.
(x) Number of refills (reorders) if necessary and permitted by the approval.
(xi) Your license number and the name of the State issuing the license.
(xii) The statement: “Extra-label use, (i.e., use of this VFD feed in a manner other than as provided for in the VFD drug approval) is strictly prohibited.”
(xiii) Any other information required by the VFD drug approval regulation.
(5) You must produce the VFD in triplicate.
(6) You must issue a VFD only for the approved or indexed conditions and indications for use of the VFD drug.
(b) What must I do with the VFD if I am a veterinarian?
(1) You must give the original VFD to the feed distributor (directly or through the client).
(2) You must keep one copy of the VFD.
(3) You must give the client a copy of the VFD.
(4) You may send a VFD to the client or distributor by facsimile or other electronic means provided you assure that the distributor receives the original signed VFD within 5 working days of receipt of the facsimile or other electronic order.
(5) You may not transmit a VFD by telephone.
(c) What are the VFD recordkeeping requirements?
(1) The VFD feed distributor must keep the VFD original for 2 years from the date of issuance. The veterinarian and the client must keep their copies for the same period of time.
(2) All involved parties must make the VFD available for inspection and copying by FDA.
(3) All involved parties (the VFD feed distributor, the veterinarian, and the client) must keep VFD's transmitted by facsimile or other electronic means for a period of 2 years from date of issuance.
(4) All involved parties must have a copy of the VFD before distribution of a VFD feed to the ultimate user.
(d) What are the notification requirements if I am a distributor of animal feed containing a VFD drug?
(1) You must notify FDA only once, by letter, that you intend to distribute animal feed containing a VFD drug.
(i) The notification letter must include the complete name and address of each business site from which distribution will occur.
(ii) A responsible person from your firm must sign and date the notification letter.
(iii) You must submit the notification letter to the Center for Veterinary Medicine, Division of Animal Feeds (HFV-220), 7500 Standish Pl., Rockville, MD 20855, prior to beginning your first distribution.
(iv) You must notify the Center for Veterinary Medicine at the above address within 30 days of any change in name or business address.
(2) If you are a distributor who ships an animal feed containing a VFD drug to another consignee-distributor in the absence of a valid VFD, you must obtain an “acknowledgment letter,” as defined in § 558.3(b)(11), from the consignee-distributor. The letter must include a statement affirming that the consignee-distributor has complied with “distributor notification” requirements of paragraph (d)(1) of this section.
(e) What are the additional recordkeeping requirements if I am a distributor?
(1) You must keep records of receipt and distribution of all medicated animal feed containing a VFD drug.
(2) You must keep these records for 2 years from date of receipt and distribution.
(3) You must make records available for inspection and copying by FDA.
(f) What cautionary statements are required for VFD drugs and animal feeds containing VFD drugs? All labeling and advertising must prominently and conspicuously display the following cautionary statement: “Caution: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice.”

Code of Federal Regulations

[65 FR 76929, Dec. 8, 2000, as amended at 72 FR 69131, Dec. 6, 2007]
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