FDA DSCSA Implementation Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

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DSCSA Implementation Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers[附网盘链接]是Food And Drug Administration于不久前发布的FDA标准，适用于United States。

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标准部分原文

Draft — Not for Implementation 1

1 Guidance for Industry 2 Drug Supply Chain Security Act Implementation: 3 Annual Reporting by Prescription Drug Wholesale Distributors and 4 Third-Party Logistics Providers 5 6 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current 7 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to 8 bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of 9 the applicable statutes and regulations. If you want to discuss an alternative approach, contact FDA staff 10 responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the 11 appropriate number listed on the title page of this guidance. 12 13 14 15 I. INTRODUCTION 16 17 This guidance describes FDA’s expectations for prescription drug wholesale distributors 18 (wholesale distributors) and third-party logistics providers (3PLs) for the annual reporting to 19 FDA as required under the Drug Supply Chain Security Act of 2013 (DSCSA). Under section 20 584(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-3(b)), 21 beginning November 27, 2014, 3PLs must report certain information to FDA, including State 22 licensure information for each facility and the name and address for each facility. Under section 23 503(e)(2)(A) (21 U.S.C. 353(e)(2)(A) (as amended by the DSCSA), beginning January 1, 2015, 24 wholesale distributors also must report certain information to FDA, including State licensure 25 information for each facility, contact information for each facility, and any significant 26 disciplinary actions taken by a State or the Federal Government. This guidance outlines the 27 information that should be submitted to FDA, the timing of the submissions, a preferred format 28 for the submissions, and a preferred method for reporting to FDA. 29 30 This guidance does not address all requirements described in the DSCSA for wholesale 31 distributors and 3PLs pursuant to sections 503(e)(2) and 584. The information provided in this 32 guidance is limited to reporting of information by wholesale distributors and 3PLs. Some 33 information outlined in the guidance is required to be reported under section 503(e)(2)(A) and 34 section 584(b) of the FD&C Act, as amended by the DSCSA. 35 36 FDA’s guidance documents, including this guidance, do not establish legally enforceable 37 responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 38 be viewed only as recommendations, unless specific regulatory or statutory requirements are 39 cited. The use of the word “should” in Agency guidances means that something is suggested or 40 recommended, but not required. 41 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).

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