A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.

Q: What does Preamble of A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches. do?

This bill, formally titled 'To increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches,' aims to clarify and make more predictable the application process for switching prescription drugs to over-the-counter status.

Q: What does INCREASING THE CLARITY AND PREDICTABILITY OF THE PROCESS FOR of A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches. do?

This section amends the Federal Food, Drug, and Cosmetic Act to establish a process for Rx-to-nonprescription switches. It allows applicants to request meetings with the Secretary to develop plans for their applications, addressing potential public health risks and necessary evidence. The Secretary is required to issue guidance within 18 months to clarify the approval process and standards for nonprescription drugs, particularly for drugs with established safety profiles. The guidance must describe how various data sources can support applications and outline procedures for sponsor meetings. The Secretary must also develop and publish a plan within one year to engage stakeholders in identifying potential drug candidates for Rx-to-nonprescription switches. The term 'Rx-to-nonprescription switch' is defined as the approval of an application seeking to market a drug as a nonprescription drug, including full and partial switches. The Comptroller General must submit a report within one year evaluating the number of applications approved, approval timelines, barriers to review, and stakeholder engagement related to Rx-to-nonprescription switches.

Last updated: 7/30/2025 · Introduced: 7/30/2025

Author: Jon Husted (R-OH)

TL;DR (AI)

This bill establishes a formal process within the Federal Food, Drug, and Cosmetic Act for prescription drugs to be approved as over-the-counter medications.
It requires the Secretary to issue guidance clarifying the approval process and standards for nonprescription drugs and to develop a stakeholder engagement plan for identifying potential drug candidates.
The Comptroller General will evaluate the approval process for Rx-to-nonprescription switches, including application numbers, timelines, and barriers to review.

119th Congressin committeeS. 2292(In Committee)Official page

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