Issue link: https://www.e-digitaleditions.com/i/1244583
6 May 2020 Tablets & Capsules I Muffie Fulton Chronicled Summary of the MediLedger DSCSA Pilot Project report to the FDA track and trace Under the US Drug Supply Chain Security Act (DSCSA), by November 27, 2023, all drug product manufacturers, repackagers, distributors, and dispensers must exchange trans- action information and statements in an interoperable electronic manner at the package level (track and trace). This article summarizes a report submitted to the FDA by the MediLedger Pilot Project demonstrating that a system using blockchain technology can achieve compliance with the DSCSA track and trace requirements. n February of 2019, the FDA requested proposals for pilot projects to demonstrate an electronic interoperable system for the confidential track and trace of pharma- ceuticals throughout the supply chain as outlined in the DSCSA [1]. The FDA requested reports from these pilot projects in late 2019 or early 2020 that could inform the agency and industry stakeholders about possible ways forward to enable compliance with the regulation. The MediLedger Pilot Project—a consortium of 25 leading pharmaceutical manufacturers, wholesale dis-