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Over-the-Counter Monograph Reform in the CARES Act

Alert

On March 27, 2020, Congress passed H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Subtitle F of the CARES Act would significantly change FDA’s regulations of over-the-counter (OTC) monograph drugs subject to OTC Drug Review. Congress had introduced earlier versions of the bill, with the latest bill, S. 2740 – Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, introduced in October 2019. This client alert provides a summary of Subtitle F.

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