FDA DSCSA Implementation Product Tracing Requirements — Compliance Policy

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DSCSA Implementation: Product Tracing Requirements —

Compliance Policy 1

Guidance for Industry This guidance represents the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION This guidance is intended for trading partners (manufacturers, wholesale distributors, and repackagers) who must provide and capture certain product tracing information, as required under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-

1). This guidance addresses the readiness of the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the FD&C Act related to the exchange of product tracing information. Requirements for the tracing of products through the pharmaceutical distribution supply chain go into effect on January 1, 2015, for manufacturers, wholesale distributors, and repackagers, and on July 1, 2015, for dispensers. This guidance announces the Food and Drug Administration’s (FDA’s) intention with regard to enforcement of the product tracing information requirements under section 582 of the FD&C Act. FDA does not intend to take action against trading partners (manufacturers, wholesale distributors, and repackagers) who do not, prior to May 1, 2015, provide or capture the transaction information, transaction history, and transaction statement required by section 582 of the FD&C Act (product tracing information) associated with each transaction of certain human, finished prescription drugs, as defined in section 581 of the FD&C Act (21 U.S.C. 360eee). FDA’s guidance documents do not typically establish legally enforceable responsibilities. Guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 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.

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