US-DSCSA

US pharma end-to-end traceability.

Definition

DSCSA progressive rollout 2015-2023, full interoperability planned November 2024 (delayed to May 2025 by FDA stabilization period). Electronic exchange via GS1 EPCIS standard (Electronic Product Code Information Services), sharing Transaction History (TH), Transaction Statement (TS), Transaction Information (TI). FDA supervision.

Origin

DSCSA signed into law 27 November 2013 by President Obama ; H.R. 3204 sections.

Example in context

Cardinal Health uses EPCIS to transmit to CVS the TI+TH of Pfizer Lyrica boxes scanned at the DC ; CVS verifies history before sale.

Related terms

• EU FMD — European twin.