The US Drug Supply Chain Security Act (DSCSA) is a federal regulation enacted to enhance the security and traceability of pharmaceuticals as they move through the supply chain. Enacted in 2013, the DSCSA aims to safeguard public health by addressing concerns related to counterfeit, adulterated, or otherwise compromised drugs.

Key provisions of the DSCSA include a phased implementation approach, with full compliance expected by 2023 followed by a one year stabilization period. The central component is the establishment of a traceability system that enables the tracking and tracing of prescription drugs at the individual package level. Manufacturers are required to affix a product identifier to each package, containing information such as the National Drug Code (NDC), serial number, lot number, and expiration date.

Pharmaceutical supply chain stakeholders, including manufacturers, repackagers, wholesale distributors, and dispensers, are mandated to exchange transaction information, history, and statements (T3 information) when transferring ownership of pharmaceutical products. This information must be electronically accessible and retrievable for a predefined period, ensuring transparency and accountability throughout the supply chain.

Furthermore, the DSCSA establishes requirements for handling suspect and illegitimate products, facilitating the prompt investigation and notification of potential issues. The overarching goal of the DSCSA is to create a closed, secure supply chain that enables quick response to potential threats and ensures that only genuine and safe medications reach patients, reinforcing the integrity of the U.S. pharmaceutical distribution system.