Status of OTC Rulemakings
On March 27, 2020, the President signed the Over-the-Counter Monograph Safety, Innovation, and Reform Act into law. This act is intended to modernize the process by which FDA regulates over-the-counter monograph drugs. The FDA is in the process of implementing the changes set forth in the act and will update the public and this webpage as we have additional information.
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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