Issue Date: March 2, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Draft
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry
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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