The Drug Supply Chain Security Act (DSCSA), enacted in 2013 and fully enforced from November 2023, establishes the framework for an interoperable electronic system to identify and trace prescription drugs as they are distributed in the United States. DSCSA requires manufacturers, wholesale distributors, dispensers, and repackagers to implement product serialisation, transaction documentation, and electronic interoperability.
DSCSA Key Requirements
| Requirement | Description | Deadline |
|---|---|---|
| Product Identifier | Unique identifier (NDC + serial number + lot + expiry) on each saleable unit | Manufacturers: 2017; Repackagers: 2018 |
| Transaction Documentation | Transaction Information (TI), Transaction History (TH), Transaction Statement (TS) exchanged at each ownership transfer | 2015 (paper); 2023 (electronic) |
| Electronic Interoperability | EPCIS-based electronic exchange of transaction data between trading partners | November 2023 |
| Verification | Saleable returns verification before redistribution; suspect product investigation | November 2023 |
| Authorised Trading Partners | Only transact with licensed manufacturers, wholesale distributors, and dispensers | November 2023 |
Product Identifier Format
The DSCSA product identifier must contain four data elements encoded in a GS1 DataMatrix barcode: National Drug Code (NDC) encoded as a GTIN-14; serial number (up to 20 alphanumeric characters); lot number; and expiration date. The barcode must be human-readable and machine-readable.
EPCIS Interoperability
From November 2023, trading partners must exchange transaction data electronically using EPCIS (Electronic Product Code Information Services) or an equivalent electronic format. EPCIS events capture when, where, and what happened to a product at each step in the supply chain. The FDA has published guidance on EPCIS implementation for DSCSA compliance.
Enforcement
The FDA enforces DSCSA through inspections, warning letters, and import alerts. Non-compliant products may be refused entry into the US market. Trading partners who receive products without compliant transaction documentation must quarantine and investigate the products before distribution.