Serialization And The Drug Quality & Security Act: A Top-Down Synergistic Approach

By Mike Salinas, M&W Group, and David DeJean, Systech International

Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to the global dilemma of safeguarding the public from the proliferation of counterfeit drugs, and the Drug Quality and Security Act (DQSA). Now a law, the DQSA includes a phased timeline, extending to 2023, that requires U.S. prescription drug manufacturers to comply with a unified federal mandate regarding transaction history and serialization. While the law eliminates the “wait-and-see” attitude some manufacturers had taken, applying a synergistic approach to the forced system and procedural updates can garner overwhelming benefits.

The DQSA, signed by President Barack Obama on 27 November 2013, preempts all state regulations
pertaining to pharmaceutical traceability and ePedigrees, and creates a national standard for drug supply chain security by requiring a national pharmaceutical traceability system. The legislation also sets various serialization requirements on Manufacturers (2017), Repackagers (2018), Wholesalers (2019), and Dispensers (2020) to affix a unique product identifier, using specific data carriers (1D or 2D data matrix) on packages and/or homogeneous cases. Authorized trading partners must also be able to verify all transactions using human- or machine-readable methods. By 2023, tracing the drug product at the unit-of-sale or item level is required, including aggregation and inferences through an inter-operable electronic system. With final guidance for each phase being issued by the FDA, the pharmaceutical industry is now faced with a definitive decision – perform a major overhaul to retrofit technologies on existing packaging lines, and/or replace legacy packaging lines to comply with the DQSA requirements.