FDA Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Draft

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Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Draft[附网盘链接]是Food&Drug Administration于当前发布的FDA标准，适用于United States。

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Draft — Not for Implementation 1 Enhanced Drug Distribution Security at the Package Level Under 2 the Drug Supply Chain Security Act 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 15 I. INTRODUCTION 16 2

17 This guidance is intended to assist supply chain stakeholders, particularly trading partners, with 3

18 requirements for enhanced drug distribution security at the package level under section 582 of 19 the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the 20 Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54). Requirements for 4

21 enhanced drug distribution security, commonly referred to as the “enhanced system” go into 22 effect on November 27, 2023. 23 24 This guidance clarifies the enhanced system requirements listed in section 582(g)(1) of the 25 FD&C Act. In addition, as described in section 582(h)(3) of the FD&C Act, this guidance 26 outlines and provides recommendations on the system attributes necessary for enabling the 5

27 secure tracing of product at the package level, including allowing for the use of verification, 6

28 inference, and aggregation, as necessary. FDA views these recommendations as an important 29 tool to assist in implementing the robust enhanced system envisioned under the DSCSA. 30 31 The contents of this document do not have the force and effect of law and are not meant to bind the 32 public in any way, unless specifically incorporated into a contract. This document is intended only to 33 provide clarity to the public regarding existing requirements under the law. FDA guidance 34 documents, including this guidance, should be viewed only as recommendations, unless specific 35 regulatory or statutory requirements are cited. The use of the word should in Agency guidances 36 means that something is suggested or recommended, but not required. 37 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 Food and Drug Administration. 2

Trading partner is defined in section 581(23) of the FD&C Act. 3

Package is defined in section 581(11) of the FD&C Act. 4

For the purpose of this guidance, “enhanced system” refers to the interoperable, electronic, package-level product tracing systems and processes required by section 582(g) of the FD&C Act. 5

Product is defined in section 581(13) of the FD&C Act. 6

See section 582(h)(3) of the FD&C Act.

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