The Drug Supply Chain Security Act (DSCSA) is a U.S. law aimed at ensuring the integrity and safety of the pharmaceutical supply chain. Enacted as part of the Drug Quality and Security Act in 2013, DSCSA establishes national standards for tracking and tracing prescription medications as they move from manufacturers through wholesalers, distributors, and eventually to pharmacies and patients. Here’s a breakdown of the key requirements: 

Product Tracking: DSCSA mandates that all prescription drugs have a standardized, unique identifier (often a 2D barcode) on their packaging. This makes it easier to track medications at each point in the supply chain. 

Verification: Each trading partner (manufacturer, wholesaler, dispenser, etc.) must verify that products are legitimate and free from counterfeits before they are distributed. 

Enhanced Security: By November 2024, pharmacies and other stakeholders must implement "interoperable" systems for tracking products electronically. This step involves using systems that can communicate seamlessly across the industry. 

Documentation: Trading partners need to maintain detailed records of the products they handle and their movements. This helps track and trace drugs if a safety issue or recall occurs. 

Overall, DSCSA aims to protect patients by reducing the chances of counterfeit, stolen, or contaminated drugs entering the U.S. supply chain, making it safer and more transparent. 

 

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