In preparation for the VFD final rule, which outlines the revised process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed and that require the supervision of a licensed veterinarian), FDA released it’s final version of its industry guidance #233 titled “Veterinary Feed Directive-Common Format Questions and Answers.”
While rejecting a suggestion that FDA require a uniform veterinary feed directive form, FDA has provided a “common VFD format [that] would help veterinarians, their clients (i.e., animal producers), and distributors (including feed mills) quickly identify relevant information on the VFD.”
In addition to providing a list of information that is required, FDA has provided a blank VFD form and several examples of completed forms, several of which are reproduced below.
The information that must be included pursuant to § 558.6(b)(3) on any form utilized includes:
• the veterinarian’s name, address, and telephone number;
• the client’s name, business or home address, and telephone number;
• the premises at which the animals specified in the VFD are located;
• the date of VFD issuance;
• the expiration date of the VFD;
• the name of the VFD drug(s);
• the species and production class of animals to be fed the VFD feed;
• the approximate number of animals to be fed the VFD feed by the expiration date of the
• the indication for which the VFD is issued;
• the level of VFD drug in the feed and duration of use;
• the withdrawal time, special instructions, and cautionary statements necessary for use of
the drug in conformance with the approval;
• the number of reorders (refills) authorized, if permitted by the drug approval, conditional
approval, or index listing;
• the statement: “Use of feed containing this veterinary feed directive (VFD) drug in a
manner other than as directed on the labeling (extralabel use), is not permitted.”;
• an affirmation of intent for combination VFD drugs as described in § 558.6(b)(6); and
• the veterinarian’s electronic or written signature.
It would be surprising if veterinarians did not use the forms suggested by FDA to insure they were providing all the information required.
Not everyone is satisfied by the increased restrictions set forth by FDA regarding antibiotics for food animals provided in feed and/or water.
A number of nonprofits filed a citizen petition under section 512(e) of the Food, Drug, and Cosmetic Act, 21 U.S.C. Section 360b(e), “to request that the Commissioner of Food and Drugs withdraw approval of the use of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes.”
These nonprofits want to prohibit the use of critically important antibiotics that prevent disease in food animals. Such use is imperative to continue to protect food animals from preventable illness.