The pharmaceutical supply chain is a complex global network involving manufacturers, wholesalers, repackagers, third-party logistics providers, and dispensers. Ensuring the authenticity, safety, and integrity of prescription drugs is critical to protecting patients and maintaining public trust. However, historical vulnerabilities have allowed counterfeit, stolen, or contaminated products to infiltrate the market, compromising public health and exposing weaknesses in regulatory oversight.
To address these risks, the U.S. Congress passed the Drug Quality and Security Act (DQSA) in 2013, which included the Drug Supply Chain Security Act (DSCSA) as Title II. The DSCSA introduced a nationwide system for pharmaceutical traceability, establishing a comprehensive framework for tracking and verifying prescription drugs at the package level. Its phased implementation has mandated that all trading partners — including manufacturers, wholesalers, repackagers, and dispensers — adopt enhanced product tracing, verification, and serialization requirements. These measures help prevent counterfeit or compromised medications from entering circulation, ensure more efficient recalls, and restrict supply chain access to authorized entities only.
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