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Breaking Down the Drug Supply Chain Security Act (DSCSA)

In this three-part series, we break down the DSCSA, key concepts, and why you should serialize today. Part 1: Read a brief overview of the act.

The DSCSA mandates that manufacturers, wholesalers, and pharmacies use serialization (assigning unique product identifiers) to track and trace prescription drugs at every point in the supply chain.
The DSCSA mandates that manufacturers, wholesalers, and pharmacies use serialization (assigning unique product identifiers) to track and trace prescription drugs at every point in the supply chain.
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The Drug Supply Chain Security Act (DSCSA) sets requirements for enhancing the security of the U.S. pharmaceutical supply chain. It aims to prevent counterfeit, stolen, or harmful drugs from entering the market. The DSCSA mandates that manufacturers, wholesalers, and pharmacies use serialization (assigning unique product identifiers) to track and trace prescription drugs at every point in the supply chain.

The DSCSA is currently in a transition period after the FDA delayed the enforcement of its final requirements until November 27, 2024.- next month! This one-year delay was granted because many stakeholders in the pharmaceutical supply chain were not fully prepared to meet the enhanced security requirements initially set for November 2023. The additional time is intended to allow for the finalization of systems and processes needed for compliance, such as the secure and interoperable exchange of data across the supply chain.

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