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: Nonp…
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.
Drug Application Process for Nonprescription Drugs
FDA reviews active ingredients and labeling of over 80 therapeutic classes of drugs
OTC Drug Review Process | OTC Drug Monographs
Three-phase public rulemaking process resulting in the establishment of standards for an OTC therapeutic drug class
Status of OTC Rulemakings
Research aid for OTC rulemaking history
Small Business Assistance
Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) Drugs
Regulatory Information for OTC Drugs
Federal Register Notices, Ingredient References, and other Regulatory Information
Guidances related to Over-the-Counter Drugs
Minimizes risk to consumers from OTC drug products
Additions/Deletions for Prescription and OTC Drug Product Lists
Search "Over-the-Counter Drugs"
User Fee Programs
Over-the-Counter Monograph User Fees
Supports timely and efficient FDA review of the efficacy and safety of ingredients
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
Sunscreen meetings
Antiseptic meetings
Information for Consumers
Understanding Over-the-Counter Medicines
Also known as OTC or nonprescription medicine you can buy without a prescription
Prescription and OTC Drugs
Frequently asked Questions and Answers
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Regulation, registration and listing, importing, manufacturing and product quality of OTC products