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FDA CPG Sec 615.115 Extralabel Use of Medicated Feeds for Minor Species

蒋千琴 1/10/2022 浏览 234 FDA U.S

标准简介

CPG Sec 615.115 Extralabel Use of Medicated Feeds for Minor Species[附网盘链接]由Food&Drug Administration于不久之前发布，适用于U.S。

标准截图

CPG Sec 615.115 Extralabel Use of Medicated Feeds for Minor Species[附网盘链接]
CPG Sec 615.115 Extralabel Use of Medicated Feeds for Minor Species[附网盘链接](截图)

 

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标准部分原文

Sec. 615.115 Extralabel Use of Medicated Feeds for Minor Species Compliance Policy Guide Guidance for FDA Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) 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 office responsible for this guidance as listed on the title page. I. Introduction This revised Compliance Policy Guide (CPG) is an update to the Compliance Policy Guide published in April 2001. The revised CPG represents the Agency’s current thinking on extralabel use of new animal drugs approved for use in or on animal feed (medicated feeds) (as defined in 21 CFR Sec. 558.3(b)(8)) for minor species (as defined in 21 CFR 516.3(b). Minor species are defined by exclusion as animals other than cattle, horses, swine, chickens, turkeys, dogs and cats. The CPG is intended to provide guidance to the field concerning the Agency’s exercise of enforcement discretion with regard to the extralabel use of over-the-counter (OTC) and veterinary feed directive (VFD) medicated feeds in minor species. It does not confer any rights for or on any person and does not operate to bind FDA or the public. In general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the agency's current thinking on various topics and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidances means that something is suggested or recommended, but not required. II. Background Prior to 1994, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) did not permit the extralabel use of animal drugs, but the Agency exercised enforcement discretion regarding extralabel use of animal drugs provided certain criteria were met. These criteria were published in Compliance Policy Guide 7125.06 and were largely incorporated into the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA). AMDUCA amended the FD&C Act to permit extralabel uses under certain conditions. The regulations promulgated pursuant to AMDUCA are codified at 21 CFR part 530. AMDUCA does not permit extralabel use of medicated feeds. However, there are some minor species that cannot be practically medicated in any way other than through the use of medicated feeds. Furthermore, minor species such as fish and game birds have very few drugs approved for

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