DSCSA EDI
DSCSA readiness for pharmaceutical trading partners
The Drug Supply Chain Security Act requires product tracing, verification, and serialization for prescription drugs in the US. Trading partners exchange transaction information / history / statement (TI/TH/TS). Many programs use GS1 EPCIS events plus or instead of classic X12. SignalEDI supports X12 companion flows, readiness checklists, evidence capture, and partner onboarding — EPCIS hubs may remain a parallel system.
DSCSAEPCISserializationtraceability
What to know
The Drug Supply Chain Security Act requires product tracing, verification, and serialization for prescription drugs in the US. Trading partners exchange transaction information / history / statement (TI/TH/TS). Many programs use GS1 EPCIS events plus or instead of classic X12. SignalEDI supports X12 companion flows, readiness checklists, evidence capture, and partner onboarding — EPCIS hubs may remain a parallel system.
- SignalEDI orchestrates X12 pharmaceutical EDI, partner onboarding, and DSCSA readiness evidence. GS1 EPCIS event hubs (serialization repositories) often remain a parallel system — integrate, do not silently replace, unless the customer scopes an EPCIS connector.
- Confirm Rx products in DSCSA scope: Identify NDC list and whether OTC/exempt SKUs are excluded.
- GLN / location identity assigned: Ship-from, sold-to, and warehouse GLNs documented for each lane.
- Serialization / EPCIS vendor identified: Name the system that emits or receives EPCIS events if required.
- TI / TH / TS exchange method agreed: EPCIS, portal, X12 companion, or hybrid — per wholesaler guide.
- EPCIS vs X12 boundary documented: What SignalEDI brokers (X12/status) vs what the EPCIS hub owns.
- SignalEDI captures checklist evidence and X12 companion flows — we do not issue DSCSA certifications.
Readiness language only — confirm every McKesson, Cardinal Health, and Cencora requirement in the partner implementation guide. SignalEDI does not issue DSCSA or FDA certifications.