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SMALL ENTITY COMPLIANCE GUIDE

CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers March 2019

Download the Draft Small Entity Compliance Guide Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2010-N-0155
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Before 1996, there were only two options for dispensing new animal drugs: (1) over-the-counter (OTC), and (2) prescription. In 1996 Congress enacted the Animal Drug Availability Act (ADAA) to facilitate the approval and marketing of new animal drugs and medicated feeds. As part of the ADAA, Congress recognized that certain new animal drugs intended for use in animal feed should only be administered under a veterinarian's order and professional supervision. For example, veterinarians are needed to control the use of certain antimicrobials. Control is critical to reducing unnecessary use of such drugs in animals and to slowing or preventing any potential for the development of bacterial resistance to antimicrobial drugs. Safety concerns relating to difficulty of diagnosis of disease conditions, high toxicity, or other reasons may also dictate that the use of a medicated feed be limited to use by order and under the supervision of a licensed veterinarian. Therefore, the ADAA created a new category of products called veterinary feed directive drugs (or VFD drugs).

This guidance document is intended to provide guidance to industry on the requirements of the veterinary feed regulations.  This document also serves as a Small Entity Compliance Guide to provide guidance to small businesses on the requirements of the final rule published in June 2015 that revised the VFD regulations.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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All written comments should be identified with this document's docket number: FDA-2010-N-0155.

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