Unveiling the Regulatory Landscape of OTC (Over-the-Counter) Drugs

March 19, 2025 12:30pm

Melissa Runsten
Counsel
Debevoise & Plimpton LLP

  • Understanding the concept of “OTC” (OTC-ness)
  • Examining the OTC Review and monographs
    • Differences between approved and monographed OTC drug products pursuant to the 2020 CARES ACT reformation and modernization of the OTC drug review process
  • OTC Monograph Drug User Fee Program (OMUFA)
  • FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU)