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40 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Regulations: Supply Chain T he 2023 final deadline for full US FDA Drug Supply Chain Security Act (DSCSA) unit level interoperable traceability is looming. By now, most pharmaceutical manufacturers are properly barcoding products to meet current DSCSA-specified labeling requirements for unique prod- uct identification at the lot level. The barcodes contain digitized product data that will be used to improve patient safety by enabling major improvements in the track-and-traceability of drugs as they move through the supply chain. Now it's time for companies to begin exchanging the necessary data to ensure readiness for November 2023. Establishing interop- erability between all stakeholders up and down the supply chain is a complex undertaking—it will take every bit of time that remains before the deadline. Barcode requirements Proper barcoding sets the stage for information exchange by furnish- ing product information in a standard, digital format that all parties can understand. Full product traceability becomes possible when trading partners successfully share that data at all necessary points through the supply chain. The DSCSA requires regulated pharmaceutical products to be marked with barcodes containing four standardized data elements: a National Drug Code (embedded in the Global Trade Item Num- ber [GTIN]), serial number, lot number, and expiration date. Pack- ages ("lowest saleable units") must be marked with a 2-dimensional DSCSA's Next Big Hurdle Tracy Nasarenko Interoperability by 2023 depends on data standardization and systems compatibility between trading partners. Tracy Nasarenko is senior director Community Engagement, GS1 US. PETERSCHREIBER.MEDIA - STOCK.ADOBE.COM