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  1. Drug Supply Chain Security Act (DSCSA)

DSCSA Pilot Project Program

FDA’s Drug Supply Chain Security Act (DSCSA) Pilot Project Program has concluded, and the final program report is available so that all supply chain stakeholders can benefit from the information gathered and lessons learned. FDA considered all viable technologies and methods from the pilot projects that would support enhanced product tracing and verification. This program was an opportunity to test technologies or methods for enhanced drug distribution security requirements outlined in the law.

This program was established to assist drug supply chain stakeholders, including FDA, with developing electronic, interoperable capabilities that will identify and trace certain prescription drugs as they are distributed within the U.S. FDA worked with the selected participants to explore and evaluate methods to enhance the safety and security of the drug supply chain. Participants reflected the diversity of the supply chain, including large and small entities from all industry sectors.

The program was established to assist members of the drug supply chain with developing capabilities to identify and trace certain prescription drugs as they are distributed within the U.S.

The program goals were to:

  • identify the system attributes needed to implement the requirements of section 582 of the FD&C Act, particularly the requirement to utilize a product identifier for product tracing and verification purposes and
  • assess the ability of supply chain members to satisfy the requirements of section 582 of the FD&C Act; identify, manage and prevent the distribution of suspect and illegitimate products as defined in section 581(21) and 581(8) of the FD&C Act, respectively; and exchange product tracing information across the pharmaceutical distribution supply chain in an electronic and interoperable manner.

Selection into this program should not be interpreted as FDA’s position on an entity’s compliance with regulatory requirements or an endorsement of a particular technology, system or other approach used in the pilots.

FDA is bound by federal law and regulations to keep commercial confidential and trade secret information from public disclosure across all programs. Any such information that was submitted to us in the program has not been disclosed publicly, including confidential sales information, customer and supplier names, contractor and consultant names and business plans. All information in the individual pilot project links below has been freely provided by the program participants.

Contact the project lead with questions about a pilot project.

Pilot Project Participants

Project Leads

Pilot Project Title

Contact

AmerisourceBergen/Xavier Health

AmerisourceBergen Xavier Health End-to-End 2023 Proof of Concept Pilot

Matthew Sample:
MSample@amerisourcebergen.com

Cardinal Health

Interoperability Data Exchange Errors and Exception Handling

Maryann Nelson:
Maryann.Nelson@cardinalhealth.com

Franciscan Missionaries of Our Lady Health System (FMOLHS)

DSCSA Verification to Improve Product Traceability at FMOL Health System

Chris Chandler:
chris.chandler@fmolhs.org

GS1

Barcode Readability for DSCSA 2023 Interoperability

Tracy Nasarenko:
TNasarenko@gs1us.org

IBM/KPMG/Merck/Walmart

DSCSA Blockchain Interoperability Pilot (PDF - 1 MB)

Gloria Candelario Hossri gloria.candelario.hossri@merck.com

ICON INDICES

Web 3.0 based on Identifier system:

An autonomous system for electronic tracing of product for pharmaceutical

Anurag Saxena:
info@iconindices.in

IDLogiq

IDLogiq Next Generation Advanced REAL FIPS-Compliant Cryptographic ID Authentication with Transaction Ledger Powered by Blockchain/Distributed Ledger Technology for Decentralized Heterogeneous Global Network Computing Environment

Kelly Nguyen:
kelly@drkumo.com

Kit Check and Sandoz

Analyzing gaps and addressing key concerns and testing key concepts relating to the 2023 DSCSA requirements by utilizing and adapting existing commercial methods and technologies

Ramsey Doany:
ramsey.doany@kitcheck.com

LSPediA

Router Service Solution for Verification/Notification and Interoperability 2023

Riya Cao:
rcao@lspedia.com

MediLedger

MediLedger DSCSA Pilot

Eric Garvin:
eric@chronicled.com

Optel

Improved end-to-end drug supply chain traceability with OPTEL’s Intelligent Supply ChainTM technologies

Simon Bastarache:
simon.bastarache@optelgroup.com

The Optimal Solution

The Optimal Solution a Federated Approach to Designing the Interoperable DSCSA

Dwight de Vera:
dwight.devera@inmar.com

Pharmaceutical Distribution Security Alliance (PDSA)

DSCSA Governance Processes

Eric Marshall:
admin@members.dscsagovernance.org

PriMed Pharmaceuticals

Secondary Wholesaler Challenges During Implementation of DSCSA Required Track & Trace Platforms

Jennifer Ruggiero:
jennifer@primedrx.com

Providence Health Technologies (PHT)

FDA Small Dispenser Pilot Study

Todd Barrett:
todd.barrett@phthealth.com

rfxcel

rfxcel Verification/Notification Readiness & Extensibility Pilot

Herb Wong:
hwong@rfxcel.com

Rymedi

DSCSA Implementation in Intra and Inter Healthcare System Medicine Transfers

Jason Cross:
jcross@rymedi.com

Sanofi

Product Identifier Verifications by a Contract Manufacturing Organization on behalf of a Manufacturer Authorization Holder

Arthi Nagaraj:
Arthi.Nagaraj@sanofi.com

TraceLink

DSCSA Traceability with Distributed Ledgers and Digital Recalls Project Proposal

Brian Daleiden:
bdaleiden@tracelink.com

UCLA Health

UCLA-LedgerDomain: DSCSA Solution Through Blockchain Technology

Ben Taylor:
ben.taylor@ledgerdomain.com

 
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