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  1. How Drugs are Developed and Approved

Over-the-Counter OTC | Nonprescription Drugs

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.

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Industry Resources

OTC Monographs @ FDA

A resource for the public to view Administrative Orders (Proposed, Final, and Interim Final Orders) for OTC Monograph Drugs and view OTC Monographs.

Industry Resources

User Fee Programs

FDA User Fee Programs

Helps FDA fulfill its mission of protecting the public health and accelerating innovation in the industry

Meetings related to OTC Drugs

Information for Consumers

Contact Us

Contact Us

Regulation, registration and listing, importing, manufacturing and product quality of OTC products

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