The document, “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to Support the Drug Supply Chain Security Act," was developed in collaboration with GS1 Healthcare US®, a GS1 US industry-led standards initiative. This guideline offers pharmaceutical industry stakeholders best practices for meeting immediate lot-level management deadlines, and sets the foundation for serialized item-level traceability.
“With the passage of Drug Safety and Quality Act and the DSCSA in 2013, we now have a sound, national policy to ensure pharmacovigilance and a consistent, standardized approach for combatting counterfeiting, theft, and diversion in the U.S. pharmaceutical supply chain,” says Siobhan O’Bara, Senior Vice President of Industry Engagement, GS1 US. “The new guideline, developed by industry for industry, is timely and needed to address key decisions that must be made now. It establishes a solid standards framework as the industry continues its transition to a safer, automated, and serialized supply chain.”
The guideline focuses on how GS1 Standards, particularly the GS1 Electronic Product Code Information Services (EPCIS), support the Act’s January 1, 2015 lot-level management deadline for manufacturers, wholesalers, and repackagers, and the July 1, 2015 deadline for hospital and retail pharmacies. As a GS1 data sharing standard, EPCIS provides the data attributes and message structure needed to comply with the information handling and retrieval provisions of the DSCSA law, including Transaction Statement (a statement of compliance to specific DSCSA requirements), Transaction Information (the transfer of goods from one party to another), and Transaction History (all prior Transaction Information records). In addition, the EPCIS-based approach enables users to address requirements for serialization, starting in 2017, and item-level traceability, starting in 2023. The guideline also addresses the application of other GS1 Standards to support the law’s requirements for product serialization and item traceability, including the Global Location Number (GLN), the Global Trade Item Number® (GTIN®), the Serial Shipping Container Code (SSCC), and GS1 Data Carriers and Application Identifiers.
“The ability for stakeholders to share information at the lot level, and to identify and trace prescription drugs at the item level is essential for providing critical transparency and accountability in the pharmaceutical supply chain,” adds O’Bara. “The new guideline shares the best thinking and practical applications for how to address requirements, while also establishing a solid business process for the pharmaceutical industry as we transition to a fully automated and serialized supply chain.”
GS1 Healthcare US was established in 2008 to bring together leading manufacturers, wholesalers, healthcare providers, government agencies, and industry associations to address regulatory and business process challenges in healthcare. After the federal act passed in November 2013, GS1 US and more than 50 Initiative members from across the U.S. pharmaceutical supply chain mobilized quickly to update the existing guideline for serialization and traceability pursuant to California State law to align with the new federal DSCSA requirements. The guideline, available for download at www.gs1us.org/dscsa-guideline, is the newest addition to GS1 US DSCSA resource site.
GS1 US will continue working with industry to extend the guideline to support management of history data, contract manufacturing, repackaging, exception processing, as well as lot- and item-level data management through the 10-year transition period. For more information about GS1 Healthcare US, visit www.gs1us.org/healthcare, and for more information about GS1 US, visit www.gs1us.org.