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GUIDANCE DOCUMENT

Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry March 2018

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-0688
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health

This guidance elaborates on the standards for the interoperable exchange of transaction 16 information, transaction history, and transaction statements required by section 582 of the 17 Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1). Section 582 was 18 added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) and 19 facilitates the tracing of products through the pharmaceutical distribution supply chain by 20 requiring trading partners ( manufacturers, repackagers, wholesale distributors, and dispensers) 21 to exchange transaction information, transaction history, and transaction statements (referred to 22 collectively in this guidance as product tracing information) when engaging in transactions423 involving certain prescription drugs. This requirement took effect on January 1, 2015, for 24 manufacturers, repackagers, and wholesale distributors, and on July 1, 2015, for dispensers.

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Submit Comments Online

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-2018-D-0688.

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