By Justin Kadis, Business Development, Federal Equipment Company
The serialization mandate has had widespread effects across the industry. Congress passed the Drug Quality and Security Act (DQSA) on November 27, 2013, and with it Title II of the DSQA or the Drug Supply Chain Security Act (DSCSA). The DSCSA provides an outline for the track and trace of all pharmaceuticals throughout the supply chain, ensuring that quality and security are present as the drug passes from one supplier to another. The DSCSA includes special requirements for manufacturers, re-packagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners), mandating that all parties who deal with a drug product are equally responsible for it and that quality is not compromised and information is not lost at any point in the many phases of the supply chain. The overall goal of the DQSA is to repel counterfeits and bolster the reliability and quality of all drugs that are sold and distributed within the United States.