BioPharm International - March 2022

BioPharm International March 2022

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30 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com DSCSA's Next Big Hurdle Interoperability by 2023 depends on data standardization and systems compatibility between trading partners. T he 2023 final deadline for full US FDA Drug Supply Chain Securit y 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 product 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 interoperability 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 furnishing product information in a standard, digi- tal format that all parties can understand. Full product traceability becomes possible when trading partners suc- cessfully share that data at all necessary points through the supply chain. The DSCSA requires regulated pharmaceutical prod- ucts to be marked with barcodes containing four stan- dardized data elements: a National Drug Code (embedded in the Global Trade Item Number [GTIN]), serial num- ber, lot number, and expiration date. Packages ("lowest saleable units") must be marked with a 2-dimensional (2D) barcode (e.g., GS1 DataMatrix) barcode, and homo- geneous cases must include either a 2D or linear (e.g., GS1-128) barcode. The application of standardized data facilitates product traceability throughout the healthcare supply chain and will be used to associate the physical product markings with serialized electronic data exchange that will be required in 2023. TRACY NASARENKO is senior director Community Engagement, GS1 US. TRACY NASARENKO Quality and Regulatory Sourcebook Regulations: Supply Chain peterschreiber.media - Stock.adobe.com

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