Blockchain Traceability for Pharmaceutical Supply Chain Compliance
Reference implementation: how NDN TraceChain addresses FDA DSCSA unit-level traceability requirements for pharmaceutical distributors
Reference Scenario
The Challenge
FDA DSCSA Phase II enforcement requires complete electronic chain-of-custody documentation at the package level for all prescription drugs. A distributor relying on lot-level EDI data cannot provide the unit-level serialisation trail regulators demand. Non-compliance exposes distribution contracts and DEA licensing to risk. Manual retrieval processes make FDA inspection response times measured in weeks rather than hours.
Our Solution
NDN TraceChain is deployed across distribution centres and integrated with supplier EDI feeds. Every package movement — receipt, pick, pack, ship — is recorded as a cryptographically signed transaction on a private Ethereum network anchored to mainnet on a configurable schedule. A REST API layer exposes verification endpoints to regulators and trading partners without exposing the underlying chain directly.