Title II of the 2013 Drug Quality and Security Act (DQSA), known as the Drug Supply Chain Security Act (DSCSA), finally became law on November 27, 2023. DSCSA creates a national, uniform chain of custody for finished prescription drugs entering U.S. interstate commerce, with standards and processes for end-to-end product tracing, verification and identification from manufacturer to filled prescription. 

Specifically, the DSCSA modernizes and automates documentation and verification of prescription drugs at each stage of the legitimate supply chain, assigning unique barcode identifiers, similar to QR codes, at the lot and unit levels. This enables supply chain partners and the FDA to quickly verify each prescription’s chain of custody back to the manufacturer, with sub-second queries and responses via a decentralized network of private repositories. DSCSA also sets uniform state licensing standards for wholesale distributors and 3PLs who handle prescription drugs, and federal licensing in states with no such framework.

The system was supposed to be up and running by 2018 but full implementation was delayed by the opioid crisis, Covid-19 disruption and potential cost and complexity after a decade-long, uncertain regulatory process. Now DSCSA is technically enforceable law at the lot level, but FDA is delaying enforcement of serialization at the unit or package level for a year — a “stabilization period,” since few but the largest manufacturers, wholesale distributors or pharmacy/hospital end users are ready.

Stakes are high in an industry beset by counterfeit product, diversion of narcotics and high-end medicines, even theft for personal use. Will supply chain partners be ready by November 2024? Supply chain solutions provider Tecsys, Inc. has been working with the industry and FDA since before DSCSA was enacted by Congress, and has some tips for manufacturers, distributors, 3PLs and dispensers now playing catch-up.

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