Serialization



Prior to the enactment of the 2013 Drug Supply Chain Security Act (DSCSA) law,  to there was a  patchwork of State Drug Pedigree and tracing laws in existence. Complying with the growing number of varying State laws, members of the U.S. drug supply chain requested that Congress act and create one law that would govern the identification, management and traceability of drug products within the U.S. Members of both houses of congress drafted bills and later a single bill that was presented to and signed by President Obama on November 27, 2013.


The new system aims to facilitate the exchange of information at the individual package level about where a drug has been in the supply chain to:
Enable verification of the legitimacy of the drug product identifier down to the package level;
Enhance detection and notification of illegitimate products in the drug supply chain; and
Facilitate more efficient recalls of drug products.
DSCSA Implementation Phases 

Lot-Level Management
Started January 1, 2015 for Manufacturers, Wholesalers and Repackages; and July 1, 2015 for pharmacy (hospitals and retail): Share the 3T’s Transaction Information (TI), History (TH) and Statements (TS) at the Lot (or Batch) level of identification.

Item Serialization
Mid-Term (2017 – 2019): Manufacturer/Repackages serialize packages of drug products using a Product identifier (GS1 Global Trade Item Number® (GTIN®) or NDC), Serial Number, Lot Number and Expiration Date.

Serialized Item-Level Traceability
By November (2023), Make available information that would allow supply chain partners to trace the ownership back to the initial manufacturer or repackage.

Note: The above represents a brief summary of the major implementation phases of the DSCSA, please refer to the actual legislation for detailed information.

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