The FDA is running a pilot program to help the industry move toward meeting the 2023 requirements of the Drug Supply Chain Security Act which requires the pharmaceutical industry to be able to track legal changes of ownership of pharmaceuticals in the supply chain. The MediLedger project was one of 20 projects accepted into the pilot, and over 25 companies have joined the MediLedger pilot project.
The focus of the MediLedger pilot will be on the DSCSA requirements related to the interoperable, electronic tracing of products at the package level. Specifically, we will focus on the enhanced requirements for package-level tracing and verification that go into effect in 2023. Working Group ApproachOur working group brings together key thought leaders in DSCSA and across various Life Science companies to determine what blockchain could provide in terms of improved solutions for industry.
APhA (consulting role)
Center for Supply Chain Studies