The following quote is attributed to Theresa M. Michele, M.D., director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research

“Over-the-counter (OTC) drugs continue to save Americans time and money, and enable them to feel a sense of control over their own health. As part of OTC Monograph Reformunder the Coronavirus Aid, Relief, and Economic Security Act, also called the CARES Act, the FDA will post deemed final administrative orders for OTC drugs. These orders were established by the CARES Act and took effect on the date of enactment of the CARES Act. Certain deemed final administrative orders are based on OTC monographs that were set forth in proposed and final rules prior to the CARES Act. These orders provide a baseline of conditions that are generally recognized as safe and effective for each OTC monograph therapeutic category.

The deemed final orders will be posted using a phased approach, and publicly posted on the FDA’s new web portal, OTC Monographs@FDA. This system also will provide the public with the ability to search for proposed administrative orders and final administrative orders that add, remove or change conditions for an OTC monograph. The FDA is committed to using the new tools provided by Congress as part of OTC Monograph Reform to promote innovation in the OTC marketplace and continue to help ensure the safety and effectiveness of OTC monograph drugs.”

Additional Information

The U.S. Food and Drug Administration posted an initial batch of four deemed final administrative orders (deemed final orders) issued as part of Over-the-Counter (OTC) Monograph Reform under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

The first four deemed final orders include:

Nighttime Sleep-Aid Drug Products for OTC Human Use;

Antiflatulent Drug Products for OTC Human Use;

Topical Otic Drug Products for OTC Human Use;

Corn and Callus Remover Drug Products for OTC Human Use. 

The FDA will post deemed final orders using a phased approach on the FDA’s new IT system, OTC Monographs@FDA.

Related Information

An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act

Over-the-Counter Drug Review: OTC Monograph Reform in the CARES Act

Over-the-Counter (OTC) Drug Monograph Process

OTC Monograph Reform in the CARES Act: Safety Orders

FDA In Brief: FDA Republishing Fee Rates under the Over-the-Counter Monograph Drug User Fee Program

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.