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Guidance Issuing OfficeCenter for Veterinary Medicine
FDA regulations at 21 CFR 514.1(b)(9) require that an animal drug sponsor who is seeking approval of a drug for use in or on feed as a VFD drug must submit copies of a VFD for review by FDA’s Center for Veterinary Medicine (CVM) “in a form that accounts for the information described under §§ 558.6(b)(3) and 558.6(b)(4)” as part of the application process.
This guidance addresses the requirement for sponsor submission of a VFD found in § 514.1(b)(9) and recommends a common format for the information to be included on the VFD. Once the sponsor’s drug is approved, the VFD form provided by the sponsor will be made available for use by veterinarians when authorizing their client to obtain and use medicated feed containing the VFD drug. (Please note that a veterinarian is not required to use the sponsor’s form and may instead create his or her own VFD form.) This document also provides guidance concerning the elements that must be included on the VFD as required by § 558.6(b)(3) and the elements that may be included on the VFD as described in § 558.6(b)(4). Finally, this guidance provides examples that illustrate how a common VFD format might appear and how some information may be pre-populated on the VFD by the sponsor and subsequently completed with all of the remaining relevant information filled out by the issuing veterinarian.
This guidance only covers the contents and format of the VFD. Guidance for Industry #120, “Veterinary Feed Directive Regulation Questions and Answers,” contains more comprehensive information about the VFD process, including information about the requirements for authorizing, manufacturing, distributing, and using VFD drugs in animal feed.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-N-0155.