Earlier this month, the FDA published draft “Guidance for Industry 120: Veterinary Feed Directive Regulation Questions and Answers.” The document outlines requirements under the new VFD rule released on June 3, offers recommendations and answers questions regarding the responsibilities of the veterinarian, client and distributor of medicated feed.
Under the new rule, responsibilities of the veterinarian include:
- Must be licensed to practice veterinary medicine.
- Must be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements.
- Must write VFD orders in the context of a veterinarian-client-patient relationship (VCPR).
- Must only issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug.
- Must prepare a written (nonverbal) VFD that includes the veterinarian’s electronic or written signature.
- Must ensure the VFD includes all required information specified in the VFD regulation.
- May enter additional discretionary information to more specifically identify the animals to be treated/fed the VFD feed.
- Must include certain drug-specific information for each VFD drug when the veterinarian is authorizing the use of a drug combination that includes more than one VFD drug.
- For VFD drugs approved for use alone or in combination with one or more OTC drugs, must include on the VFD order an affirmation of intent either to restrict authorized use only to the VFD drug cited on the VFD or to allow the use of the cited VFD drug in an approved combination with one or more OTC drug(s)
- Must provide the distributor with a copy of the VFD order.
- Must provide the client with a copy of the VFD order.
- Must retain the original VFD for 2 years.
- Must provide VFD orders for inspection and copying by FDA upon request.
The guidance notes that veterinarians can file VFD forms either in paper or electronic formats. In many cases, drug companies will make VFD forms specific to their products available, but veterinarians can prepare their own VFD forms and the guidance lists the information that must be included.
An important point included in the guidance and the VFD rule is that extra-label use of VFD drugs in feed is not permitted. Examples of extra-label use of a VFD feed could include feeding animals a VFD feed for a duration of time that is different from that specified on the label, feeding VFD feed formulated with a drug level that is different from what is specified on the label or feeding VFD feed to an animal species different than what is specified on the label. According to FDA, the VFD must include the statement "Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extra-label use) is not permitted."
View the draft Guidance 120 document on the FDA Center for Veterinary Medicine website.