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GUIDANCE DOCUMENT

DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for Industry November 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-D-2270
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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 under section 582(d)(1) of the FD&C Act took effect on July 1, 2015.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-2270.

 
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