Case Study: DSCSA GS1 DataMatrix Barcode Adoption Assessments

Pharmaceutical distributors take snapshot of where manufacturers stand on Phase 2 adoption


As you and your company prepare to meet the requirements of the U.S. FDA Drug Supply Chain Security Act* (DSCSA), the industry is currently in Phase 2 of the ten-year rollout. While Phase 1 focused on the the adoption of lot-level management among all supply chain partners, Phase 2 focuses on item-level serialization. Manufacturers are required to affix or imprint on their packages (and homogenous cases) a 2-dimension (2D) barcode—a standardized graphic that includes both a human-readable form and a machine-readable data carrier. The barcode must contain the product identifier, consisting of four product identifiers (or GS1 Application Identifiers (AIs)):

  • A GS1 Global Trade Item Number® (GTIN®) containing the National Drug Code (NDC)
  • A serial number
  • A lot number
  • An expiration date

The GS1 DataMatrix 2D barcode meets the requirements of DSCSA through its AIs. To assess where the pharmaceutical manufacturer segment (and their products) stands on Phase 2 of the 2013 DSCSA implementation, AmerisourceBergen (ABC) and McKesson Pharmaceutical (McKesson)—in collaboration with GS1 Healthcare US®—each conducted DSCSA barcode assessments in May 2017. This paper summarizes a snapshot of serialization adoption.
 

 

DSCSA Data Matrix Paper: Barcode Assessment paper


* Source: 2013 Drug Supply Chain Security Act

“By offering feedback now, we can help manufacturers become DSCSA compliant.”

Matt Sample, Senior Director of Secure Supply Chain, AmerisourceBergen

"We wanted to set a baseline and look at not only who had converted their packaging lines, but who actually had real product in the market properly marked.”

Scott Mooney, Vice President of Distribution Operations, Supply Chain Assurance, McKesson

To learn more read our case study.

 


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