The US Food and Drug Administration (FDA) announced in February, that, under the Drug Supply Chain Security Act, it will launch a Pilot Project Program as an initiative to explore technologies to enhance tracing and verification of pharmaceutical products in the US supply chain and ease DSCSA implementation.
Trace Histories, TraceLink’s submission to the FDA’s pilot program, was built on the company’s digital supply network. Shabbir Dahod, president and CEO, TraceLink, said in a statement that Trace Histories uses its standards-based compliance for track and trace in the pharmaceutical supply chain for the application of blockchain solutions.
The blockchain network solution uses a ‘gather upon request’ approach, with permissioned data to share critical and confidential information with authorized partners in an interoperable format.
TraceLink’s network includes 275,000 partners on its end-to-end digital supply network are already validated, therefore, providing data to companies with the opportunity to leverage validated blockchain technology.
“Trace Histories maintains the pseudonymity of blockchain participants and control of confidential informational within each participant’s system by only enabling the disclosure of information necessary to respond to verified trace requests,” said Dahod.
The blockchain network solution was designed to meet the final 2023 DSCSA deadline, in which members of the US supply chain will need to have processes and systems in place to meet the requirements for an interoperable, electronic tracing of products at packaging level.
Dahod told us, "We have been working on this submission since the FDA announced the program last month and are excited to partner with several pharmaceutical manufacturers, wholesale distributors, retail pharmacy chains, and hospital networks to help the industry gain real world insights to collaborate on a solution that will enhance patient safety and solve for difficult business challenges."
Participants in the pilot project include pharmaceutical manufacturers, wholesale distributors, major retail pharmacy chains, diversified healthcare organizations, and third party logistics providers.
Should Trace Histories be accepted into the pilot program it will be guided and managed by TraceLink’s Blockchain Network Innovation Forum.