09/20/2021 | Press release | Distributed by Public on 09/20/2021 08:49
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 Reform under 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 [email protected]. 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."
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.