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 In this section:

        How Drugs are Developed and Approved

Over-the-Counter OTC | Nonprescription Drugs

                        
                The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
          Over-the-Counter (OTC) Drug Review | OTC Monograph Reform  in the CARES Act


                Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription DrugsHow Drugs are Developed and Approved Over-the-Counter OTC | Nonprescription Drugs
  	
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    PrintOn 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 Paragraphs
          Industry ResourcesOTC 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 drugsOTC Drug Review Process | OTC Drug Monographs
            Three-phase public rulemaking process resulting in the establishment of standards for an OTC therapeutic drug classStatus of OTC Rulemakings
            Research aid for OTC rulemaking historySmall Business Assistance
            Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) DrugsRegulatory Information for OTC Drugs
            Federal Register Notices, Ingredient References, and other Regulatory InformationEnforcement Activities | OTC Drugs Branch
            Minimizes risk to consumers from OTC drug productsGuidances related to Over-the-Counter Drugs
            Search "Over-the-Counter Drugs"
          Industry ResourcesAdditions/Deletions for Prescription and OTC Drug Product Lists
            Use in conjunction with  current Cumulative Supplement and Orange Book
          User Fee ProgramsOver-the-Counter Monograph User Fees
            Supports timely and efficient FDA review of the efficacy and safety of ingredientsFDA User Fee Programs
            Helps FDA fulfill its mission of protecting the public health and accelerating innovation in the industry
          Meetings related to OTC DrugsSunscreen meetingsAntiseptic meetings
          Information for ConsumersUnderstanding Over-the-Counter Medicines
            Also known as OTC or nonprescription medicine you can buy without a prescriptionPrescription and OTC Drugs
            Frequently asked Questions and Answers
          Contact UsContact Us
            Regulation, registration and listing, importing, manufacturing and product quality of OTC products

                                                                                  Content current as of:
      06/20/2023
                  
                   
Regulated Product(s)
		 Drugs
			  			     			  						              
			
			
			
			
						  Over-the-Counter DrugsOver-the-Counter OTC | Nonprescription Drugs                
                          

                        Proposed Rule: Nonprescription Drug Product with Additional Condition
          Over-the-Counter (OTC) Drug Review | OTC Monograph Reform  in the CARES Act


                        Historical Status of OTC Rulemakings
 
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