To amend the Federal Food, Drug, and Cosmetic Act to provide for expedited approval of priority nonprescription drugs, and for other purposes.

This bill amends the Federal Food, Drug, and Cosmetic Act by creating a new section to establish a designation for priority nonprescription drugs . The Secretary of Health and Human Services may designate a nonprescription drug as a priority if it is intended for a novel nonprescription indication that offers a meaningful public health benefit, is a new molecular entity , or contains an active ingredient never before available in a nonprescription drug. This designation aims to streamline the regulatory pathway for innovative over-the-counter medications. Upon designation, the Secretary is mandated to take actions to facilitate development and expedite the review of the drug's application. These actions include holding meetings with the sponsor, providing timely advice, involving senior management, and assigning a cross-disciplinary project lead to ensure an efficient review process. However, drugs subject to a risk evaluation and mitigation strategy (REMS) or controlled substances are explicitly excluded from this priority designation. The bill also requires the Secretary to publish a list of conditions for which nonprescription drugs could provide a meaningful public health benefit, subject to public comment. Furthermore, it mandates a report to Congress within four years on the program's effectiveness, including the number of requests, approvals, and resources used. The authority granted by this section is set to cease on September 30, 2032.