DSCSA & GS1 — pharma serialisation.
The US Drug Supply Chain Security Act (DSCSA) and GS1 standards together govern pharma item-level serialisation, aggregation and traceability.
RTLS, RFID and IoT systems are the layer that captures the events. This is the operator-level summary of what the regulations require and how to design for them.
DSCSA — the regulatory baseline
The Drug Supply Chain Security Act (US, signed 2013, in full force November 2023 after phased implementation) requires unit-level serialisation of prescription drugs through the US supply chain.
Each saleable unit must carry a unique identifier; manufacturers, repackagers, wholesale distributors and dispensers must record and exchange transaction information, history and statements. Non-US operations supplying US markets must align.
GS1 standards — the data layer
DSCSA implementation rests on GS1 standards: GS1 SGTIN (Serialized Global Trade Item Number) for item identity, SSCC (Serial Shipping Container Code) for aggregation hierarchies,
EPCIS (Electronic Product Code Information Services) for event recording, and the CBV (Core Business Vocabulary) for event semantics.
GS1 standards are also the EU FMD (Falsified Medicines Directive) data foundation.
RFID / RTLS as the capture layer
Item-level data capture at production, packaging, warehouse and dispensing requires high-speed, high-accuracy reads. RAIN RFID is increasingly used alongside 2D barcodes for aggregation verification and warehouse handling.
The RTLS layer adds location and dwell context for cold-chain and chain-of-custody scenarios. See our serialisation-and-custody solution.
Integration with EPCIS repositories
Captured events flow into EPCIS repositories — either operator-owned or third-party services (TraceLink, RxScan, others).
The integration architecture must handle high event volumes, support standard GS1 event types (Object, Aggregation, Transaction, Transformation) and provide audit-grade retention. We design this at gate 1 for pharma deployments.
Frequently asked questions
Is DSCSA different from EU FMD?
Yes, but conceptually aligned. EU FMD requires similar unit-level identification and verification with different repository architecture (EMVS hub-and-spoke). Multinational pharma operations design for both regimes; we scope this in stage 1.
Does GS1 EPCIS work for non-pharma traceability?
Yes — automotive, food, retail traceability all use GS1 EPCIS. The standard is industry-agnostic; specific data models vary by sector.
How is RFID used alongside 2D barcodes?
Typically: 2D barcodes provide unit-level human-readable identity; RFID provides high-speed aggregation verification at case and pallet level. Both feed the same EPCIS event log.
What about cold-chain integration?
Temperature events from cold-chain sensors flow into the same EPCIS repository alongside serialisation events, giving a unified product-history record. See cold-chain monitoring.
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