TraceLink OPUS U.S. DSCSA Compliance

TraceLink Inc. is a US company that runs the OPUS cloud network for life sciences supply chains. Its US compliance solution helps pharmaceutical manufacturers, wholesale distributors and pharmacies meet the Drug Supply Chain Security Act (DSCSA), which requires interoperable, serialised tracing of prescription drugs.

Partners exchange serialised transaction data in EPCIS format through a single connection to the OPUS network, which TraceLink says has over 290,000 members. The solution scans aggregated codes on receipt, verifies product identifiers via VRS to handle suspect and returned products, and manages exceptions with trading partners. TraceLink also offers serialisation compliance modules for other countries.

• Single connection: Links to the OPUS network of trading partners.
• EPCIS exchange: Shares serialised transaction data in EPCIS.
• Aggregation scanning: Reads case and pallet codes on receipt.
• VRS checks: Verifies product identifiers for returns and suspect items.
• Exception handling: Manages data discrepancies with partners.
• WMS link: Integrates with warehouse management systems.

• A Vietnamese generic drug maker exporting to the US exchanging DSCSA data with distributors. 2) A pharmaceutical distributor verifying returned products via VRS. 3) A contract manufacturer connecting serialised data to multiple brand owners.

• One connection replaces many point-to-point links with trading partners. 2) VRS verification speeds handling of returns and suspect products. 3) Aggregation scanning cuts receiving time at distribution centres. 4) Exception workflows help resolve data mismatches with partners.

DSCSA interoperability requirements have phased in through 2025, and other markets keep adding drug serialisation rules. Vietnamese pharmaceutical exporters working with US partners, and local distributors watching domestic drug traceability, need standards-based serial data exchange.

Headquartered in the USA. In a February 2026 release, TraceLink reported about 300 new DSCSA live links per week at peak in 2025 and billions of serialised EPCIS events processed. Customers named include Value Drug Company, PharmaLink and Summit SD.