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GUIDANCE DOCUMENT

DSCSA Implementation: Product Tracing Requirements — Compliance Policy December 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-2254
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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

If unable to submit comments online, please mail written comments to:

Dockets Management
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-2014-D-2254.

 
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