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The Drug Supply Chain Security Act and 2D Vaccine Barcodes
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January 2020
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[PDF-199.31 KB]
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Description:Prepared for National Center for Immunization and Respiratory Diseases Immunization Services Division by Regina Cox, Millie Malai, Deloitte Consulting LLP.
The Drug Supply Chain Security Act (DSCSA), signed into law on November 27, 2013, aims to enhance the FDA’s ability to protect consumers by identifying and removing counterfeit and dangerous medicines/products from the U.S. pharmaceutical supply chain. The DSCSA stipulates that by 2023, the U.S. will have an electronic, interoperable system that will be able to monitor the movement of prescription drugs from manufacturing to dispensation. To operationalize this objective, the DSCSA requires that manufacturers imprint, in human readable form, a product identifier to each package and case of a product that they intend to introduce into the supply chain. In addition, the product identifier must include the National Drug Code, Serial Number, Lot Number and Expiration date encoded within a 2D barcode.
Product serialization is a key building block and enabler of traceability; in the public health context, traceability can support improved recall capabilities and the ability to validate the authenticity of pharmaceutical products. These gains, however, are highly dependent on the integration and interoperability of information systems and processes.
Drug-Supply-Chain-Security-Act-508.pdf
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Pages in Document:15 numbered pages
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