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In September 2023, the U.S. Food and Drug Administration (FDA) released the Prescription Drug Use-Related Software (PDURS) framework, providing a regulatory foundation for the regulation of software-generated end-user outputs that are directly related to prescription drug use and treated as part of drug labeling. From a digital medicine perspective, this review systematically summarizes the core concepts and technical features of the PDURS framework and examines its potential impacts on personalized medicine, drug safety, information transparency, medication use monitoring, and pharmaceutical innovation. The findings suggest that by transforming drug-use information into software-generated, patient-facing outputs that are subject to drug labeling requirements, PDURS supports patient-centered individualized medication decision-making, enhances adverse event monitoring and risk management, and facilitates the continuous generation and application of real-world data. 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