Verify the DSCSA T3 set (Transaction Information + History + Statement) completeness, validate the GS1 SGTIN, and map the EPCIS 2.0 event type. DSCSA §582 — enforcement live since Aug 2025.
DSCSA §582GS1 EPCIS 2.0Zero PIIClient-side onlyUS FDA · Enforcement Aug 2025
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Scope
Validates the three-document T3 set required by DSCSA §582: Transaction Information, Transaction History, Transaction Statement. Also validates GS1 SGTIN format (GTIN-14 + serial) and maps the EPCIS 2.0 event type. Feeds the saleable-returns verifier (art-113).