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Meeting the Needs of DSCSA Requirements

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In 2013, members of the U.S. drug supply chain requested that Congress create a law that would govern the identification, management, and traceability of all drug products within the United States.*

The 2013 Drug Supply Chain Security Act (DSCSA) 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
  • Facilitate more efficient recalls of drug products

GS1 US DSCSA Implementation Suite

As industry completes its preparations to go live with DSCSA serialization requirements for 2017, more and more trading partners are focusing on the journey to DSCSA item-level traceability starting in 2023. The "GS1 US DSCSA Implementation Suite” provides pharmaceutical industry stakeholders the tools they need to plan, pilot and implement DSCSA requirements. Release 1.2 of the "GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability”, instructs users on how to implement GS1 Standards, particularly the GS1 Electronic Product Code Information Services (EPCIS), for DSCSA lot-level management, serialization, and item-level traceability.

DSCSA implementation phases

Lot-level management
Started on January 1, 2015 for manufacturers, wholesalers, and repackagers, 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/repackagers 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 repackager.

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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*For information about the act, see the 2013 Drug Supply Chain Security Act

For information on the delay enforcement, see the FDA Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. June 30, 2017

Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.