FDA DSCSA Implementation Product Tracing Requirements for Dispensers — Compliance Policy (Revised)

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DSCSA Implementation Product Tracing Requirements for Dispensers — Compliance Policy (Revised)[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于United States。

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DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(d)(1)) related to the exchange of transaction information, transaction history, and transaction statements (product tracing information). For dispensers, requirements for the tracing of products through the pharmaceutical distribution supply chain 2

under section 582(d)(1) of the FD&C Act took effect on July 1, 2015. On July 6, 2015, FDA published a Notice of Availability in the Federal Register (80 FR 38449) announcing a guidance document entitled “DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy.” The guidance described FDA’s intention with regard to enforcement of the product tracing information requirements under section 582(d)(1) of the FD&C Act. The guidance stated that FDA does not intend to take action against dispensers who, prior to November 1, 2015, (1) accept ownership of product without receiving product tracing information, prior to or at the time of a transaction, as required by section 582(d)(1)(A)(i) of the FD&C Act, or (2) do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act. As described below, FDA is extending this compliance policy to transactions that occur before March 1, 2016. Section IV of this guidance provides further detail about the scope of this compliance policy and FDA’s expectations for dispensers and trading partners involved in transactions with dispensers. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, 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 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

“Dispenser” is defined in section 581(3) of the FD&C Act (21 U.S.C. 360eee(3)).

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