Aligned to DSCSA enhanced drug distribution security
Ergopharm has completed the alignment of its serialisation and aggregation data to the enhanced, interoperable, package-level tracing requirements of the US Drug Supply Chain Security Act (DSCSA), which became effective on 27 November 2023 with a stabilisation period running to 27 November 2024.
The DSCSA was signed into law on 27 November 2013 as Title II of the Drug Quality and Security Act (Public Law 113-54). It set a ten-year phase-in toward an electronic, interoperable system for tracing prescription drug products at the individual package level as they move through the US supply chain. The final phase, enhanced drug distribution security, became effective on 27 November 2023, requiring trading partners to exchange transaction information electronically and to trace product using package-level identifiers rather than lot-level records. The US Food and Drug Administration subsequently announced a one-year stabilisation period, to 27 November 2024, during which industry continues to build and stabilise the interoperable systems needed for full compliance.
“Package-level serialisation and EPCIS aggregation are engineered into Ergopharm's packaging so that each unit can be traced through the supply chain, in step with the DSCSA's enhanced requirements.”
Ergopharm's own packaging and data processes are built around the product identifier that DSCSA relies upon: a GS1 DataMatrix (ECC200) encoding the GTIN, expiry, batch or lot, and a unique serial number. At our Vadodara facility, each saleable pack is marked as an SGTIN, cases and pallets carry an SSCC, and the parent-child relationships between packs, cases and pallets are captured as aggregation data so that scanning an outer case resolves every unit contained within it. This aggregation is what allows a downstream trading partner to trace an individual package without opening every case.
To meet the interoperability expectation, Ergopharm structures its aggregation and event data as EPCIS events (EPCIS being ISO/IEC 19987), recording the commissioning, packing, aggregation and shipping of each unit against time, location and business step. Transaction information is prepared for electronic exchange with trading partners so that, where product is destined for the US market, package-level tracing data travels with the goods rather than as a separate lot-level statement. These are descriptions of Ergopharm's own processes and packaging; they are not a claim of any national regulatory approval.
The alignment sits within Ergopharm's wider pharmaceutical quality system under ICH Q10 and its change-management discipline, with the serialisation line qualified through IQ, OQ and PQ and data handled to ALCOA+ integrity principles. The same DataMatrix and aggregation architecture also underpins Ergopharm's readiness for other jurisdictions' safety-feature and verification regimes, allowing a single serialisation and EPCIS backbone to serve multiple export markets from one master data source.
Key facts
- Instrument
- US Drug Supply Chain Security Act (DSCSA), PL 113-54, signed 27 Nov 2013
- Enhanced security effective
- 27 Nov 2023, with FDA stabilisation period to 27 Nov 2024
- Package identifier
- GS1 DataMatrix (ECC200): GTIN, expiry, lot, serial; pack = SGTIN, case/pallet = SSCC
- Interoperable data
- Aggregation captured as EPCIS events (ISO/IEC 19987)
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.