Questions about the New VFD Rule? Read this…

June 17, 2015 — 

The FDA has published draft " Guidance for Industry 120: Veterinary Feed Directive Regulation Questions and Answers." The document provides general information about the new VFD rule released on June 3 and answers specific questions about the rule.

In order for a VFD to be lawful, the veterinarian issuing the VFD:

• Must be licensed to practice veterinary medicine (21 CFR 558.6(b)(1)(i));
• must be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements (21 CFR 558.6(b)(1)(ii));
• must write VFD orders in the context of a VCPR (21 CFR 558.6(b)(1)(ii));
• 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 (21 CFR 558.6(b)(2));
• must prepare a written (nonverbal) VFD (21 CFR 558.6(b)(7)) that includes the veterinarian’s electronic or written signature (21 CFR 558.6(b)(3)(xv));
• must ensure the VFD includes all required information specified in the VFD regulation (21 CFR 558.6(b)(3));
• may enter additional discretionary information to more specifically identify the animals to be treated/fed the VFD feed (21 CFR 558.6(b)(4));
• 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 (21 CFR 558.6(b)(5));
• 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) (21 CFR 558.6(b)(6));
• must provide the distributor with a copy of the VFD order (21 CFR 558.6(b)(8));
• must provide the client with a copy of the VFD order (21 CFR 558.6(b)(9));
• must retain the original VFD for 2 years (21 CFR 558.6(a)(4)); and
• must provide VFD orders for inspection and copying by FDA upon request (21 CFR 558.6(a)(5))

In addition, the extra-label use of VFD drugs in feed remains illegal. 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."