FDA CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers

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Draft – Not for Implementation Veterinary Feed Directive Regulation Questions and Answers (Revised) Guidance for Industry Small Entity Compliance G uide This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance using the contact information on the title page. I. INTRODUCTION 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 (VFD) drugs. In June 2015, FDA published a final rule that revised the VFD regulations in 21 CFR 558.6 and introduced clarifying changes to the definitions in 21 CFR 558.3 (80 FR 31708, June 3, 2015). This guidance provides information to assist veterinarians, VFD feed distributors (e.g., feed mills), and clients (i.e., owners or other caretakers of the animals) in complying with the requirements in the 2015 VFD final rule. This guidance also serves as a Small Entity Compliance Guide (SECG), to aid industry in complying with the requirements of the VFD final rule. FDA has prepared this SECG in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This document is intended to provide guidance to small businesses on the requirements of the final rule. Generally, FDA guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

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