The Drug Supply Chain Security Act (DSCSA) and Drug Quality Security Act (DQSA) are a set of regulations introduced by the U.S. Food and Drug Administration (FDA) in 2013 to help ensure the quality and safety of prescription drugs and to prevent counterfeit/illegitimate drugs from entering the U.S. market. The regulations apply to any prescription pharmaceutical product shipped into the United States.

The DSCSA introduced a 10-year phased approach (2013-2023) to secure the overall prescription drug supply chain. By November 2018, the DSCSA requires all manufacturers of prescription drugs to serialize the lowest saleable unit of measure (i.e., item-level serialization) of each of their products.

In the years following the 2018 item-level serialization mandate, from 2019 to 2023, the DSCSA introduces additional regulations that apply more specifically to re-packagers, wholesalers, and dispensers of pharmaceutical products with the goal of a fully interoperable track and trace pharmaceutical supply chain to verify the authenticity of all prescription pharmaceutical products.

 

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