FDA drug supply chain pilot project spurs blockchain advancements

Posted Mar 16, 2019 by Tim Sandle
FDA’s Pilot Program under the Drug Supply Chain Security Act (DSCSA) requires the Agency to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. This includes blockchain.
File photo: German customs officials seize their largest haul of illicit pharmaceuticals
File photo: German customs officials seize their largest haul of illicit pharmaceuticals
Philippe Huguen, AFP/File
The DSCSA initiative is intended to enhance the security of the pharmaceutical distribution supply chain, and consider any pilot projects conducted prior to enactment of the law.
Blockchain is software that provides a digital ledger system for records and log transactions, by grouping them into chronologically-ordered blocks. This makes it ideal for tracking supplies, and ensuring that required storage conditions have been achieved and that goods have not been tampered with.
TraceLink provides one the world’s largest integrated digital supply networks, focused on providing real-time information sharing for better patient outcomes. The company has announced the submission of Trace Histories, which is an interoperable blockchain network solution designed to support the DSCSA program.
The blockchain for pharmaceuticals project is important, given that by 2023, members of the U.S. supply chain will need the processes and systems in place to meet the DSCSA requirement for an interoperable, electronic tracing of pharmaceutical products at the packaging level.
TraceLink’s Trace Histories solution integrates directly into a healthcare company’s existing global infrastructure. This integration will allow for the secure exchange of critical and confidential information with authorized partners in an open, interoperable format. Such a program will be a step towards helping companies meet the final 2023 DSCSA deadline requiring full unit level traceability across the supply chain.
TraceLink has submitted for the FDA pilot project program, which was open for submissions until March 11, 2019. Partners for the program have not yet been announced.
Commenting on the submission, Shabbir Dahod, president and CEO, TraceLink told Pharmaceutical Technology: “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.”
He adds: “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.”
Blockchain is quickly increasing in interest for pharmaceutical companies, based on success stories relating to other sectors of the economy like financial services and energy suppliers.