558.6—Veterinary feed directive drugs.
(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 ).
(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.
(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.
(viii)
Any special instructions and cautionary statements necessary for use of the drug in conformance with the approval.
(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.”
(6)
You must issue a VFD only for the approved or indexed conditions and indications for use of the VFD drug.
(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.
(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.
(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.
(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.
(1)
You must keep records of receipt and distribution of all medicated animal feed containing a VFD drug.
(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.”