Incentives And Risks From OTC Drug Monograph Revamp

Law360 (May 29, 2020, 6:14 PM EDT) -- On March 27, President Donald Trump signed into law the Coronavirus Aid, Relief and Economic Security Act, also known as Phase 3 of the coronavirus stimulus legislation. Title III, Subtitle F of the CARES Act, a provision unrelated to the current coronavirus pandemic, is an overhaul to the over-the-counter drug monograph system in the U.S.

This article analyzes the five key provisions of the OTC monograph reform, with a particular focus on the first four:

An outline of the status of currently marketed OTC monograph drugs;

An administrative process by which the U.S. Food and Drug Administration will establish/amend a monograph...

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