Assessing Current Implementation of DSCSA Serialization Requirements 

Pharmaceutical distributors take snapshot of where manufacturers stand on Phase 2


On November 27, 2017, pharmaceutical manufacturers faced an important deadline: meeting the Phase 2 requirements of the 2013 Drug Supply Chain Security Act (DSCSA). Although the U.S. FDA recently issued guidance* indicating that it will delay enforcement of those requirements until November 2018, the implementation deadline remains in effect. 

While Phase 1 focused on the exchange of lot-level chain-of-ownership data among all supply chain partners, Phase 2 focuses on item-level serialization. Pharmaceutical products must be marked with a National Drug Code (NDC), Serial Number, Lot Number, and Expiration Date in both machine-readable and human-readable format.**

To assess where the industry stands on Phase 2 implementation, AmerisourceBergen (ABC) and McKesson Pharmaceutical (McKesson)—in collaboration with GS1 Healthcare US® — each conducted DSCSA barcode assessments in May 2017. This paper presents their findings to offer a snapshot of implementation progress. 

 

DSCSA Data Matrix Paper: Barcode Assessment paper


“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

Read the paper to learn more.

 


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*For information on the delay enforcement, see the FDA Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.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

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

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.