Regulatory Guidelines for Switching of Prescription Drugs to Over-The -Counter Status

The regulatory guidelines governing the transition of prescription drugs to over‑the‑counter (OTC) status across three major jurisdictions — the United States, the European Union, and Japan — with supplemental reference to the UK and Canada. By analyzing the statutory foundations, approval pathways, evidence requirements, and post‑market safety frameworks unique to each region, the study aims to identify both convergences and divergences in global Rx‑to‑OTC regulatory practice. A special focus is placed on recent innovations, including the FDA’s “Additional Conditions for Nonprescription Use” (ACNU) final rule, the role of real‑world evidence, and emerging digital self‑selection tools. The analysis draws upon a review of 19 drug substances across 10 therapeutic areas to identify common reasons for switch rejections and opportunities for harmonization. The thesis concludes with evidence‑based policy recommendations designed to balance expanded consumer access with robust patient safety protections in an increasingly self‑care‑oriented healthcare environment