Over-the-Counter Monograph Reform in the CARES Act

Over-the-Counter Monograph Reform in the CARES Act

March 27, 2020, Covington 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.