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This bill amends the Federal Food, Drug, and Cosmetic Act to establish clearer procedures and guidance for pharmaceutical companies seeking to convert prescription drugs to over-the-counter (nonprescription) status. The bill requires the FDA to issue guidance within 18 months on the approval process for such switches, including evidentiary standards and how companies can demonstrate consumer safety and appropriate self-selection. It also requires the FDA to develop a stakeholder engagement plan and authorizes pre-submission meetings to help applicants develop their applications. Additionally, the bill directs the Government Accountability Office to report on the number and timeline of approved switches and any barriers to the review process.
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