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# CARES Act OTC Monograph Provisions Explained
- URL: https://www.fdaweb.com/cares-act-otc-monograph-provisions-explained/
- Published: 2020-04-09T12:00:00.000Z
- Updated: 2026-09-14T16:10:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146535

A Hyman, Phelps & McNamara 4/6 memo summarizes the OTC Monograph Drug Review Reform provisions that were included in the Coronavirus Aid, Relief, and Economic Security Act of 2020\. The [memo](http://www.fdalawblog.net/wp-content/uploads/2020/04/CLient-memo-regarding-OTC-monograph-reform-and-OMUFA-00645822.pdf?ref=fdaweb.com) says OTC monograph reform legislation that has been stalled in Congress for more than two years found its way into the CARES Act.

“The OTC monograph reform legislation has been supported by both FDA and regulated industry as a means to modernize the, what some people have identified as archaic and cumbersome, existing OTC monograph system which had become bogged down by the requirements of the rulemaking process, limited resources, and other constraints,” the memo says.

It says the overarching purpose is to move the OTC monograph drug review framework from one of notice and comment rulemaking to an administrative order process exempt from certain requirements of the Administrative Procedures Act. Also, the legislation is designed to provide for innovation such as additional active ingredients, new indications, and new dosage forms. And it is intended to give FDA the means to more quickly respond to and address safety concerns, the memo says.