FDA publishes more insight on VFD

Revised guidance includes insight on pioneer and generic drug authorization and how veterinarians can authorize VFD drugs.

The U.S. Food and Drug Administration (FDA) has issued revised Guidance for Industry (GFI) #120, “Veterinary Feed Directive Regulation Questions and Answers.” The FDA has also posted to its website a list of states that have veterinarian-client-patient-relationship (VCPR) requirements for Veterinary Feed Directives (VFDs) and include the key elements of the Federally-defined VCPR, as well as those states that do not. This list was developed by FDA working together with state regulatory authorities. Veterinarians in states that do not require a VFD to be issued within the context of a VCPR that includes federally-defined key elements will be required to follow the federal VCPR requirements. The list may change over time as states update their veterinary practice requirements.

Revised GFI #120 reflects minor changes from the draft version of the revised guidance that was published for comment in June 2015 , including an additional question and answer about VFD authorization for pioneer and generic drugs, and clarification on how a veterinarian can authorize or limit the use of a VFD drug when used in combination with over-the-counter drugs.

In June 2015, FDA published a final rule that revised the VFD regulations. The revised guidance document released Sept. 29 includes revisions that are consistent with the requirements in the June 2015 VFD final rule and answers questions related to the final rule.

 The VFD final rule becomes effective October 1, 2015, and initially affects only those drugs that currently are approved as VFD drugs (avilamycin, florfenicol, and tilmicosin). Other feed-use animal drugs, specifically medically important antimicrobial products currently available Over-the-Counter (OTC), will be subject to these requirements when they are changed to VFD status as part of the Agency’s judicious use initiative (see Guidance for Industry #213 for additional details). While some products may change sooner, FDA expects most changes to be implemented in a coordinated manner by January 1, 2017.

Although this guidance has been finalized, you can submit comments at any time. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2010-N-0155 in the search box. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2010-N-0155 on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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