FDA DSCSA Pilot Project

The 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 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.

Focus

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.

Our Goals

  • Model events in a serialization data exchange environment for prescription drugs using Blockchain/distributed ledger system (including aggregation capabilities) while representing the mix of products and levels of packaging in the supply chain
  • Show how distributed ledger systems could be interoperable
  • Show how the system can be used to perform investigationsManage errors and describe how exception handling could be performed by targeting known weaknesses in the supply chain
  • Manage errors and describe how exception handling could be performed by targeting known weaknesses in the supply chain
  • Simulate illegitimate products/transactions to test a process or system
  • Determine the best business and financial model
  • Identify issues with system performance and capabilities
  • Define the potential IT architecture
  • Evaluate human factors that could present implementation and adoption challenges
  • Share knowledge of blockchain and separate the reality from the hype
  • Demonstrate how blockchain technology may be suited to respond to DSCSA requirements and how it can provide strategic advantages

Current Pilot Status

Current Pilot Status

Pilot Participants

AmerisourceBergen
Amgen
APhA (consulting role)
Cardinal Health
Center for Supply Chain Studies
Chronicled
Dermira
Endo
Fedex
FFF Enterprises
Genentech
Gilead
GS1
GSK
Inmar
Lilly
Maxor
McKesson
Novartis
Pfizer
Sanofi
Vaxserve
Walgreens
Walmart