TraceLink Is First & Only Solution Provider to Process 100 Million Transaction History Files
TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, today announced that it has processed over 100 million Transaction History files to ensure that its pharmaceutical manufacturer, distribution and dispenser customers are achieving lot-level compliance under the U.S. Drug Supply Chain Security Act (DSCSA). Tracing requirements for lot-level data from manufacturer to dispenser are the first phase of complex regulations included in the multifaceted U.S. law.
“This unprecedented milestone demonstrates our unique position as the only provider that can deliver a proven solution with scalability, security and network accessibility. As the largest, globally networked track and trace solution for the life sciences industry, TraceLink is helping more customers stay one step ahead of federal regulations than any other provider,” said Shabbir Dahod, president and CEO of TraceLink. “In preparation for the next stage of intricate and complicated serialization requirements quickly approaching, we are already enabling our customers to serialize pharmaceutical products in nine global markets – and comply with specific country regulations in advance of their respective deadlines. Our proven track record gives customers confidence that they are eliminating the business risks associated with new supply chain regulations, allowing them to focus on their patients’ health, safety and quality of life.”
The DSCSA law includes three phases with corresponding deadlines in which pharmaceutical manufacturers, distributors, hospitals and pharmacies must comply:
- Phase I: Lot Level Tracing and Verification, which was initiated in January 1, 2015 and required the creation and exchange of Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) at the Lot (or Batch) level of identification for all pharmaceutical sales from manufacturer to dispenser as well as the development of systems and processes to enable verification of such compliance information for suspect product investigations.
- Phase II: Item Serialization, phasing in between November 2017 and November 2020, requires that each saleable unit of pharmaceutical products be marked with a unique Product Identifier including the NDC, Serial Number, Lot Number and Expiration Date. This phase also requires that companies only engage in transactions involving serialized products and that the product identity be verified in situations such as saleable returns and suspect product investigations.
- Phase III: Serialized Item-Level Traceability, beginning November 2023, requires the implementation of an interoperable, electronic tracing capability at the item or saleable unit level for all transactions from manufacturer to dispenser, allowing for serialized item traceability back to product origin.
Built on the Amazon Web Services global cloud infrastructure, TraceLink’s Life Sciences Cloud is the only secure and validated cloud solution with a proven network model designed specifically for life sciences companies. This purpose-built and scalable architecture positions TraceLink customers to confidently prepare for all aspects of DSCSA as soon as they connect into the network, minimizing the need for further investments throughout the phases of compliance.
To learn more about meeting global pharmaceutical compliance deadlines and how to build a flexible serialization, track and trace, and reporting platform for the U.S., the EU, China, Brazil, South Korea, India, Turkey, Argentina and other countries, please visit www.tracelink.com.