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12 Mar 2019

TraceLink submits an interoperable blockchain network solution for FDA DSCSA Pilot Project Program

Trace Histories is a purpose-built distributed ledger solution for ensuring patient safety by 2023 DSCSA deadline.

TraceLink has submitted its interoperable blockchain network solution for the FDA Pilot Project Program under the Drug Supply Chain Security Act (DSCSA). Built on TraceLink’s digital supply network, Trace Histories leverages distributed ledger technology and is designed specifically to help pharmaceutical manufacturers, wholesale distributors, pharmacies, and hospitals securely exchange information and satisfy the 2023 DSCSA requirement.

“The 275,000+ partners on our end-to-end digital supply network are already validated, which provides companies with a unique opportunity to leverage blockchain technology, while ensuring the safe exchange of data,” said Shabbir Dahod, president and CEO, TraceLink. “By combining our nearly two decades of expertise in standards-based compliance for track and trace in the pharmaceutical supply chain with our deep technical knowledge, we have created Trace Histories, a breakthrough blockchain solution. Trace Histories maintains the pseudonymity of blockchain participants and control of confidential information within each participant’s system by only enabling the disclosure of information necessary to respond to verified trace requests.”

With the unique advantage of leveraging TraceLink's end-to-end digital network and existing base of pre-verified customers and trade partners, Trace Histories is a distributed ledger network that integrates directly into companies’ existing global compliance and serialization infrastructures. The blockchain network solution employs a “gather upon request” approach with permissioned data security, allowing companies to securely share critical and confidential information with authorized partners in an open, interoperable format to meet the final 2023 DSCSA deadline requiring full unit level traceability across the supply chain. Trace Histories was designed from the ground up to be standardized and support interoperability across blockchain networks.

Other participants in TraceLink’s pilot project include pharmaceutical manufacturers, wholesale distributors, major retail pharmacy chains, diversified healthcare organizations, and third-party logistics providers. The pilot project will be guided and managed by TraceLink’s Blockchain Network Innovation Forum.

By 2023, members of the US supply chain will need to have processes and systems in place to meet the DSCSA requirement for an interoperable, electronic tracing of pharmaceutical products at the packaging level. Announced by the FDA last month, the DSCSA Pilot Project Program is a 2019 effort to explore technologies that will enhance the tracing and verification of pharmaceutical products in the US supply chain.

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