[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.6]

[Page 362-364]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec.  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 Sec.  
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 indications for use.
    (v) Name of the animal drug.
    (vi) Level of animal drug in the feed, and the amount of feed 
required to

[[Page 363]]

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 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 Sec.  
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

[[Page 364]]

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.''

[65 FR 76929, Dec. 8, 2000]