The recent FDA call for proposals to demonstrate pharma traceability objectives of the Drug Supply Chain Security Act (DSCSA) has a least one candidate: TraceLink. The company has announced that it will join with an unnamed number of manufacturers, wholesalers, pharmacy chains, health systems and logistics providers to run a pilot demonstration. And it is using the pilot project to showcase a new solution, Trace Histories, which the company characterizes as “a distributed ledger network that integrates directly into companies’ existing global compliance and serialization infrastructures.”
TraceLink has the advantage that hundreds of pharma manufacturers, as well as numerous other pharma supply chain participants, have linked into the company’s TraceLink Cloud, either as direct customers or as trading partners of other customers in the network.
According to a company statement, “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 is said to be interoperable with other blockchain networks, and is known that there are several such efforts underway among solution providers and manufacturers. The use of blockchain technology is a potential solution to the as-yet-undetermined process to document and verify product movements in the supply chain, but among companies that aren’t necessarily direct customers of each other.
The FDA pilot program, while mandated by DSCSA, does not offer any remuneration to participants. FDA will make a final cut of the number of projects being supported in the near future.