FDA Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers Questions and Answers

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Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers Questions and Answers[附网盘链接]是于之前发布的FDA标准，适用于United States。

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Draft — Not for Implementation 1 Annual Reporting by Prescription Drug Wholesale 2 Distributors and Third-Party Logistics Providers: 3 Questions and Answers 1

4 Guidance for Industry 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic.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 and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 15 I. INTRODUCTION 16 17 This guidance addresses questions and clarifies FDA’s expectations for annual reporting to FDA 18 by prescription drug wholesale distributors (wholesale distributors) and third-party logistics 19 providers (3PLs) as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as 2

20 amended by the Drug Supply Chain Security Act of 2013 (DSCSA). 21 22 FDA previously published a draft guidance for industry entitled DSCSA Implementation: Annual 23 Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers 3

24 (Annual Reporting draft guidance). This question-and-answer guidance supplements the 25 information in the Annual Reporting draft guidance by addressing questions and comments that 4

26 FDA received about annual reporting since publication of the Annual Reporting draft guidance. 27 28 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 29 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 30 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 1

This guidance has been prepared by the Office of Compliance in 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

Title II of Public Law 113-54. In particular, see sections 503(e)(2) and 584 of the FD&C Act (21 U.S.C. 353(e)(2) and 360eee-3). 3

In December 2014, FDA issued the draft guidance entitled DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers. When final, that guidance will represent FDA’s current thinking on this topic. For the most recent version of a guidance, check the FDA Drugs guidance Web page at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 4

More information about reporting is on the Wholesale Distributor and Third-Party logistics Providers Reporting Web page (http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm4

23749.htm).

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