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BOSTON, MA - (February 27, 2024) - As the United States Drug Supply Chain Security Act (U.S. DSCSA) approaches its full regulatory enforcement deadline on November 27, 2024, there has been a significant increase in preparation activities among TraceLink customers and their trading partners. Key statistics highlighting the industry’s progress on TraceLink include:
- Over 1,300 TraceLink customers and partners are already exchanging DSCSA Electronic Product Code Information Services (EPCIS) messages, well ahead of the November deadline.
- More than 1.7 million DSCSA EPCIS transactions have been exchanged by TraceLink customers in the past 12 months.
- Over 1 million of these EPCIS transactions occurred in the last 90 days alone, indicating rapid acceleration and maturation in readiness efforts.
- 26,070 companies have already been successfully enabled for DSCSA compliance on TraceLink, and they have created over 47,000 links to exchange EPCIS information.
As part of go-live activities, TraceLink has solved complex operational and integration challenges related to DSCSA across its pharmacy, hospital, wholesale distributor, and manufacturing customers and partner networks, including:
- Exchanging DSCSA-compliant EPCIS transactions
- GTIN and pack-level master data sharing by leveraging more than 47,000 in-network, registered GTINs on TraceLink
- Digital capture and reconciliation of unit-level and aggregation information during the receiving and shipping of serialized products
- Saleable returns and suspect product verification processes
- DSCSA exception collaboration and resolution based on PDG-issued guidance
In addition, many TraceLink customers are leveraging their unique digital network investment for DSCSA to solve other critical supply chain orchestration challenges, including:
- Enhanced collaboration and visibility through the interoperable exchange of Purchase Orders, PO Acknowledgements, Invoices, Inventory Balances, and many more B2B transactions.
- Improved product recall identification, management, and collaboration, including moving toward targeted recall notifications based on serialized information.
- Proactive drug shortage detection using AI and machine learning techniques leveraging anonymized, real-time U.S. medicine supply chain signals on the TraceLink network.
“We have been actively planning for this rapid surge of customer go-lives and have prepared our services and support teams of more than 200 people to manage this activity. In addition, we have an excellent group of certified implementation and consulting partners to help customers succeed with DSCSA,” said Shabbir Dahod, President & CEO, TraceLink.
TraceLink's "Integrate Once, Interoperate with Everyone™" architecture is central to its DSCSA compliance leadership, eliminating the need for extensive point-to-point integrations and significantly reducing time, cost, and risk. This approach, unlike those used by other vendors, efficiently facilitates information exchange across the supply chain. Additionally, as serialization increases processing demands, TraceLink's native cloud architecture has demonstrated unparalleled scalability and effectiveness in managing these requirements at massive scale, highlighting our commitment to delivering advanced, future-proof supply chain solutions.
Mike Shaw, Vice President of Information Technology at Value Drug Company noted, “As we gear up for the November 2024 deadline, TraceLink’s ‘Integrate Once, Interoperate with Everyone™’ strategy has streamlined the onboarding process for our trading partners. With minimal effort from our staff, we can swiftly connect with partners, freeing up our resources to concentrate on customer assistance and ensuring our warehouse systems and operations align with our DSCSA obligations.”
Anticipated to continue through 2024, the momentum in preparing for DSCSA requirements showcases TraceLink’s dedication to ensuring robust readiness among its customer and partner base. Partnering with TraceLink not only significantly reduces risk and accelerates regulatory compliance, but also strengthens drug supply security and patient care. TraceLink's more than a decade of compliance and global supply chain orchestration experience supports the end-to-end pharmaceutical supply chain by offering scalable compliance foundations and essential tools for digitalization to tackle industry challenges efficiently.
Is your current solution provider prepared and staffed to handle the complex requirements of DSCSA, both before and after the regulation takes full effect?
