On June 27, 2022, the FDA announced the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule is intended to increase options for the development and marketing of safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. For more information, see The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use.
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.
Sub-Topic ParagraphsA resource for the public to view Administrative Orders (Proposed, Final, and Interim Final Orders) for OTC Monograph Drugs and view OTC Monographs.
FDA reviews active ingredients and labeling of over 80 therapeutic classes of drugs
Three-phase public rulemaking process resulting in the establishment of standards for an OTC therapeutic drug class
Research aid for OTC rulemaking history
Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) Drugs
Federal Register Notices, Ingredient References, and other Regulatory Information
Minimizes risk to consumers from OTC drug products
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Use in conjunction with current Cumulative Supplement and Orange Book
Supports timely and efficient FDA review of the efficacy and safety of ingredients
Helps FDA fulfill its mission of protecting the public health and accelerating innovation in the industry