What are the conditions that veterinarians must fulfill when issuing a veterinary feed directive? As set forth in the Dec 8, 2000 Federal Register notice on the final rule implementing the VFD, they are as follows:
1) You must be appropriately licensed.
2) You must issue a VFD only within the confines of a valid veterinarian-client-patient relationship.
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:
a) You and your client's name, address, and telephone number, and, if the VFD is faxed, facsimile number
b) 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
c) Date of treatment and, if different, date of prescribing the VFD drug d) Approved indications for use
e) Name of the animal drug
f) Level of animal drug in the feed, and the amount of feed required to treat the animals
g) Feeding instructions, with the withdrawal time
h) Any special instructions and cautionary statements necessary for use of the drug in conformance with the approval
i) Expiration date of the VFD
j) Number of refills (reorders) if necessary and permitted by the approval
k) Your license number and the name of the state issuing the license
l) The statement: "Extralabel use (ie, use of this VFD feed in a manner other than as provided for in the VFD drug approval) is strictly prohibited."
m)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.
The rule goes on to delineate what veterinarians must do with the VFD:
- You must give the original VFD to the feed distributor (directly or through the client).
- You must keep one copy of the VFD.
- You must give the client a copy of the VFD.
- 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 five working days of receipt of the facsimile or other electronic order. You may not transmit a VFD by telephone.
The VFD record-keeping requirements are as follows:
- The veterinarian, client, and VFD feed distributor must keep the VFD original for two years from the date of issuance.
- All involved parties must make the VFD available for inspection and copying by the FDA.
- All involved parties must keep each VFD transmitted by facsimile or other electronic means for two years from the date of issuance.
- All involved parties must have a copy of the VFD before distribution of a VFD feed to the ultimate user.
In addition, 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."