Assessing Current Implementation of DSCSA Serialization Requirements 

Three pharmaceutical wholesalers assess 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 gain an up-to-date view of where the industry stands on Phase 2 implementation, AmerisourceBergen and McKesson Pharmaceutical (McKesson)—in collaboration with GS1 Healthcare US® — each conducted an updated DSCSA barcode assessment in May 2018. Cardinal Health joined the effort, conducting its own barcode assessment of homogeneous cases from pharmaceutical manufacturers, with support from GS1 Healthcare US. The 2018 Update: Implementation of DSCSA Serialization Requirements paper presents their findings to offer a snapshot of implementation progress.

 

2018 Update: Assessing Current Implementation of DSCSA Serialization Requirements

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DSCSA Data Matrix Paper: Barcode Assessment paper


Resources


“We’re taking this time to enhance our processes to ensure efficient receipt, pick, pack, and ship for grandfathered and new products. … The transition to 2D barcodes is huge for us operationally and will help take our business and our customers to the next level of delivering efficient and safer healthcare.”

Michael Rowe, Manager of Operations Technology (Track & Trace), Cardinal Health

"Conducting the assessment has given us very specific data about each of our suppliers’ DSCSA barcode implementations….”

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

“Serialization requires additional technology to generate, capture, and send serial numbers. We expect to see a large number of barcodes serialized over the next six months. That’s why we’re reaching out to help test these new labels, ensuring that they are done correctly without issues.”

Ameer Ali, Senior Manager of Secure Supply Chain & Manufacturer Operations, AmerisourceBergen


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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.