This bill seeks to enhance the clarity and predictability of the process for developing applications for Rx-to-nonprescription drug switches . It amends the Federal Food, Drug, and Cosmetic Act to allow applicants to request meetings with the Secretary to plan their applications, addressing potential public health risks and necessary evidence. These meetings are intended to help define study designs and the format and content of the planned application, with all discussions being formally documented. Furthermore, the legislation mandates the Secretary to issue comprehensive guidance within 18 months to clarify the process and approval standards for nonprescription drugs, particularly for Rx-to-nonprescription switches involving drugs with established safety profiles. This guidance will detail how various data sources, including medical literature and human experience, can support applications. It will also outline evidentiary expectations for demonstrating that consumers can appropriately self-select and use the drug, and comprehend its labeling, recommending the incorporation of additional mechanisms like mobile applications. The bill also requires the Secretary to develop and publish a plan within one year to engage stakeholders in identifying promising prescription drugs suitable for nonprescription switches. To assess the effectiveness and challenges of the current system, the Comptroller General is directed to submit a report within one year. This report will evaluate the number of approved switches, average approval times, and any barriers to timely review, alongside opportunities for inter-agency collaboration.