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

USA119th CongressHR-9774| House 
| Updated: 7/20/2026
Robert E. Latta

Robert E. Latta

Republican Representative

Ohio

Cosponsors (1)
Greg Landsman (Democratic)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Jul 20, 2026
Introduced in House
Jul 20, 2026
Referred to the House Committee on Energy and Commerce.
  • July 20, 2026
    Introduced in House


  • July 20, 2026
    Referred to the House Committee on Energy and Commerce.

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

USA119th CongressHR-9774| House 
| Updated: 7/20/2026
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.
View Full Text

Suggested Questions

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Timeline
Jul 20, 2026
Introduced in House
Jul 20, 2026
Referred to the House Committee on Energy and Commerce.
  • July 20, 2026
    Introduced in House


  • July 20, 2026
    Referred to the House Committee on Energy and Commerce.
Robert E. Latta

Robert E. Latta

Republican Representative

Ohio

Cosponsors (1)
Greg Landsman (Democratic)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted