FDA DSCSA Pilot Project

FDA Pilot Program

The FDA is running a pilot program to help the industry move toward meeting the 2023 requirements of the Drug Supply Chain Security Act (DSCSA) which requires the pharmaceutical industry to be able to track legal changes of ownership of pharmaceuticals in the supply chain. The MediLedger Pilot Project, a consortium of leaders from 25 pharmaceutical companies, was accepted into the program with the goal of evaluating blockchain as the solution to the 2023 DSCSA requirements.

Pilot Participants

AmerisourceBergen
Amgen
APhA (consulting role)
Cardinal Health
Center for Supply Chain Studies
Chronicled
Dermira
Endo
FedEx
FFF Enterprises
Genentech
Gilead
GS1

GSK
Hikma
Inmar
Lilly
Maxor
McKesson
Novartis
Novo Nordisk
Pfizer
Sanofi
Vaxserve
Walgreens
Walmart

MediLedger DSCSA Pilot Final Report

In February 2020 the Final Pilot Report was released detailing how and why blockchain can meet the 2023 DSCSA requirements for an interoperable, confidential change of ownership system within the pharmaceutical supply chain. The report outlines the conclusions established during the pilot, the approach used to reach those conclusions through the working group model, the technology behind the solution and associated risks, and a vision for the use of blockchain across the industry.

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