Here you will find resources to help pharmacists in understanding the DSCSA and the impact it will have on pharmacy practice, as well as methods for meeting compliance. ASHP is continuing to work with the FDA to resolve unanswered questions and ensure that members are adequately prepared when enforcement of DSCSA begins.
What is the DSCSA?
On November 27, 2013, the Drug Quality and Security Act (DQSA) was signed into law, and Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA) sets forth new definitions and requirements related to product tracing. The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed in the United States. This new system will enhance the U.S. Food and Drug Administration’s ability to help protect U.S. consumers by improving detection and removal of potentially dangerous products from the pharmaceutical distribution supply chain.
