FDA Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act
标准简介
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act[附网盘链接]由FDA于过去发布，适用于US。标准截图
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标准文档类型为Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft — Not for Implementation 1 Definitions of Suspect Product and Illegitimate Product for 2 Verification Obligations Under the Drug Supply Chain Security Act 1
3 Guidance for Industry 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person 9 and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 10 requirements of the applicable statutes and regulations. To discuss an alternative approach, 11 contact the FDA staff responsible for this guidance as listed on the title page. 12 13 14 15 16 I. INTRODUCTION 17 18 The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) amended the 19 Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish requirements for product 20 tracing, verification, and product identification for certain drug products that are distributed in 21 the United States. Many of the terms used in these requirements are defined in section 581 of the 22 FD&C Act (21 U.S.C. 360eee). 23 24 FDA is issuing this guidance to interpret the terms used in the definition of suspect product set 25 forth in section 581(21) of the FD&C Act, and the definition of illegitimate product set forth in 26 section 581(8) of the FD&C Act, to assist trading partners in meeting verification obligations 27 (including notification) under section 582(b)(4), (c)(4), (d)(4), and (e)(4), respectively. 28 29 This guidance revises the draft guidance for industry Definitions of Suspect Product and 30 Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act 31 issued in March 2018. This revision clarifies certain points of the March 2018 draft guidance, 32 and also adds FDA’s current understanding of the term stolen. 33 34 The contents of this document do not have the force and effect of law and are not meant to bind the 35 public in any way, unless specifically incorporated into a contract. This document is intended only to 36 provide clarity to the public regarding existing requirements under the law. FDA guidance 37 documents, including this guidance, should be viewed only as recommendations, unless specific 38 regulatory or statutory requirements are cited. The use of the word should in Agency guidances 39 means that something is suggested or recommended, but not required. 40 41 II. BACKGROUND 42 1
This guidance has been prepared by the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research and the Office of Regulatory Affairs at the FDA. 1
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