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Pharmaceutical Manufacturing and Packing Sourcer

Are You Ready for the Drug Supply Chain Security Act?




As the industry prepares for full implementation of the Drug Supply Chain Security Act (DSCSA), members of the pharmaceutical supply chain including manufacturers, distributors, repackagers, third-party logistics providers, and dispensers must comply with requirements to track, trace, and verify the identity and validity of prescription drugs by 2023. Under the new regulations, pharmaceuticals must be marked with a national drug code, serial number, lot number, and expiration date. Additionally, the lowest saleable units must be marked with 2D barcodes and, in some cases, with a linear barcode (1). These changes will also require the industry to collect, manage, and share unprecedented volumes of data capturing serialised electronic data matched to the products moving through the supply chain.

What Is the Current Status of the Industry?

A barcode assessment study, conducted in the summer of 2019, indicated that the pharma supply chain is seeing the saturation of serialised products; an estimated 90% of all Rx products had a DSCSA Barcode, which is huge progress compared to a prior study conducted in 2019 that showed 20-30%.

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About the author

Matt Sample is the Vice President of Manufacturer Operations at AmerisourceBergen. He is responsible for the maintenance of vendor and item master data, driving the adoption of supply chain standards internally and with manufacturer trading partners, and leading the implementation of DSCSA across all AmerisourceBergen business units. In addition to the core drug distribution business responsibilities, Matt is responsible for the DSCSA serialisation efforts within their pharma manufacturing and repackaging businesses. He has over 15 years of experience in the medical device, pharma, and life science industry, working both for manufacturers and wholesalers.
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