Historical Status of OTC Rulemakings
Status of OTC Rulemakings Prior to the CARES Act
On Friday, March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The CARES Act includes provisions that govern the way certain over-the-counter (OTC) drugs are regulated in the United States.
Prior to passage of the CARES Act, OTC monographs were established, revised, and amended using the rulemaking process. Final OTC drug monographs (final monographs) were codified in regulations under Title 21 of the CFR. Prior to establishment of a final monograph, generally recognized as safe and effective (GRASE) conditions for a therapeutic category were set forth in proposed rules as tentative final monographs. At the time of the passage of the CARES Act, certain OTC monographs were still at the proposed rulemaking stage, either in whole or in part.
The CARES Act added section 505G to the FD&C Act, which revised the framework for the regulation of OTC monograph drugs. Under section 505G of the FD&C Act, the rulemaking process for establishing, revising, and amending OTC monographs was replaced with an administrative order process. Congress provided that, under section 505G(b)(8) of the FD&C Act, a final monograph or tentative final monograph that establishes conditions of use for a drug described in section 505G(a)(1) or (2) of the FD&C Act and that represents the most recently issued version of the conditions of use, including as modified, in whole or in part, by any proposed or final rule, is deemed to be a final order.
This page represents that status of OTC rulemakings prior to the enactment of the CARES Act (e.g., before March 27, 2020). FDA will retain this page for historical reference only. For the current status of OTC monographs, refer to the OTC Monographs@FDA portal.
The Over-the-Counter (OTC) drug category web site contains Federal Register notices organized by therapeutic category subtopics. Each web page also links to therapeutic category pages organized chronologically.
This rulemaking history site is intended as a research aid and is not an official FDA record. We have tried to make these histories accurate and complete. Should you find an error, however, please let us know so that we can correct it.
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