FDA DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs How to Exchange Product Tracing Information

标准简介

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs How to Exchange Product Tracing Information[附网盘链接]是于当前发布的FDA标准，适用于U.S。

标准截图

 

标准文档说明

标准文档类型为DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs How to Exchange Product Tracing Information[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 1

1 Guidance for Industry 2 DSCSA Standards for the Interoperable Exchange of Information for Tracing of 3 Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing 4 Information 5 6 7 This draft guidance, when finalized, will represent Food and Drug Administration’s (FDA’s or 8 Agency’s) current thinking on this topic. It does not create or confer any rights for or on any 9 person and does not operate to bind FDA or the public. You can use an alternative approach if 10 the approach satisfies the requirements of the applicable statutes and regulations. If you want to 11 discuss an alternative approach, contact the FDA staff responsible for implementing this 12 guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on 13 the title page of this guidance. 14 15 16 17 I. INTRODUCTION 18 19 This guidance addresses the pharmaceutical security provisions in section 582 of the Federal 20 Food, Drug, and Cosmetic Act (FD&C Act). Section 582 was added by the Drug Supply Chain 21 Security Act (DSCSA) (Title II of Public Law 113-54) and facilitates the tracing of products 2

22 through the pharmaceutical distribution supply chain by requiring certain trading partners 23 (manufacturers, repackagers, wholesale distributors, and dispensers) to exchange transaction 24 information, transaction history, and a transaction statement (product tracing information) when 3

25 engaging in transactions involving certain prescription drugs. This requirement goes into effect 26 on January 1, 2015, for manufacturers, repackagers, and wholesale distributors, and on July 1, 27 2015, for dispensers. FDA, in consultation with other appropriate Federal officials and 28 pharmaceutical distribution supply chain stakeholders, is required, under section 582(a)(2)(A) of 29 the FD&C Act, to establish initial standards for the interoperable exchange of the product tracing 30 information related to each transaction of certain human, finished, prescription drugs covered by 31 the statute. 32 33 This document establishes initial standards for the interoperable exchange of product tracing 34 information, in paper or electronic format, for compliance with sections 582(a), (b), (c), (d), and 35 (e) of the FD&C Act. These standards will help trading partners provide product tracing 36 information to subsequent trading partners through the extension and/or use of current systems 1

This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs (ORA) at the Food and Drug Administration. 2

“Trading partner” is defined under FD&C Act § 581(23)(A). Although third-party logistics providers are also considered trading partners under FD&C Act § 581(23)(B), the requirements of sections 582(a)-(e) are not applicable to them. 3

“Transaction information,” “transaction history,” and “transaction statement” are defined under FD&C Act §§ 581(26), (25), and (27).

网盘链接

百度网盘：https://pan.baidu.com/s/15KGlCUruA7j_sp7ZcHtirQ
提取码：e9ni