The Drug Supply Chain Security Act (DSCSA) is building toward an interoperable, electronic, unit-level track-and-trace system for prescription drugs in the US. For pharmacies, the practical takeaway is simple: knowing what you have at the lot level is no longer enough — you increasingly need to know it at the unit level.
The building blocks, in plain terms
- ✓Serialization — a unique identifier on each sellable unit, not just the lot
- ✓GS1 GTIN / SGTIN — the standard product and serialized-unit identifiers
- ✓EPCIS — the standard for exchanging track-and-trace events between trading partners
- ✓Verification — confirming a product's identifier is legitimate
Why it matters beyond compliance
Unit-level traceability isn't just a regulatory checkbox — it's what turns a recall from a multi-day fire drill into a query. When every unit's genealogy is recorded, you can trace any lot forward to every shipment and backward to every raw-material lot in seconds. That's a patient-safety and business-continuity capability, not just paperwork.
What this means operationally
Capturing and passing serialized data means your systems have to speak these standards natively. A platform with serialization built in — rather than bolted on — records the identifiers and events as a byproduct of normal work, so compliance and recall readiness come for free. See how it works in 503B software and across security & compliance.
The direction is clear: more traceability, at finer granularity. Building on serialization now means you're ready as requirements tighten — instead of scrambling later.
Frequently asked questions
Does the DSCSA require unit-level serialization?+
The DSCSA is moving the US supply chain toward interoperable, electronic, unit-level tracing. Exact obligations depend on your role and timing, so confirm your specific requirements — but the direction is unit-level.
How does serialization help with recalls?+
With unit-level identifiers recorded across receipt, production, and shipment, you can trace any lot forward and backward across the supply chain in seconds — turning a recall into a query.