DSCSA Compliance
DSCSA (Drug Supply Chain Security Act) compliance is the set of regulatory requirements for tracking and tracing prescription drugs throughout the US pharmaceutical supply chain, including serialization, transaction documentation, verification, and ultimately full electronic interoperable traceability.
Why It Matters
DSCSA requires pharmaceutical companies to maintain a complete chain-of-custody for every package of prescription drugs from manufacturer to dispenser. Non-compliance can result in product seizure, import refusal, and regulatory action. The November 2023 requirements mandate electronic interoperable traceability at the package level.
The FourKites Perspective
The FourKites Inventory Twin supports lot-level tracking with batch identification across all in-transit and warehoused pharmaceutical products. The Shipment Twin provides chain-of-custody documentation for in-transit movement. The Graph's continuous sanctions screening adds a compliance layer: are any carriers or intermediaries in the distribution chain flagged on any regulatory watchlist? Sam processes the transaction documentation that DSCSA requires at each custody transfer.