Title II of the US Drug Quality and Security Act, requiring an interoperable, electronic, package-level traceability system for prescription drugs across manufacturers, repackagers, wholesale distributors and dispensers, including serialization, verification and the electronic exchange of transaction information.
Drug Supply Chain Security Act
Statute United States
The Drug Supply Chain Security Act phased in over a decade toward a single end state: unit-level electronic traceability of prescription drugs through the US supply chain, with trading partners passing transaction information to one another electronically and interoperably.
- Serialization - Every saleable unit carries a unique product identifier.
- Electronic, interoperable exchange - Transaction information moves between trading partners as data, not as paper or PDF.
- Verification - Trading partners can verify a product identifier with the manufacturer.
- Converged on EPCIS - The industry settled on a GS1 event standard as the interchange format rather than each pair of partners inventing one.
DSCSA is the exception that proves the rule for this sector. Almost every supply chain regulation in this catalog compels a record or a report and leaves the exchange to the market, which reliably produces reporting software and no contracts. DSCSA compelled the exchange itself — partner to partner, electronically, interoperably — and the industry responded by converging on a shared event format and building the platforms to move it. The State of Supply Chain APIs found the traceability vendors built for this obligation among the strongest in their segment, which is the measurable difference between naming a report and naming an interface.
Referenced in API Evangelist papers
This regulation shows up in my published research. These reports read the machine-readable evidence provider by provider — and put this regulation in the context of a real sector.
The State of Supply Chain APIs
The closest any supply chain regime comes to compelling machine-to-machine exchange — and the segment built for it outscores the segments around it.
Implemented by these standards
A regulation is the law; a standard is the machine-readable contract that makes it real. These are the technical standards that implement this regulation, catalogued at standards.apievangelist.com.
EPCIS
The format the pharmaceutical industry converged on to satisfy the interoperable electronic tracing requirement.
