Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking  History for General Procedures and Policies for OTC Drug ProductsHistorical Status of OTC Rulemakings Rulemaking  History for General Procedures and Policies for OTC Drug Products
  
  	
    Share
    Post
    Linkedin

    Email
    PrintGeneral Procedures and Policies for OTC Drug Products found on this page:

Adverse Event Reporting
	Drug Review Procedures
	Category II Active Ingredients
	Administrative Record
	Miscellaneous Policies
	OTC/Prescription Dual MarketingGeneral Procedures and Policies for OTC Drug Products: Adverse Event Reporting

Proposed Rule
			Date
			*FR* CitationNotice of Availability: Draft Guidance
			10/15/2007
			72FR58316Guidance
			10/15/2007Final Rule
			Date
			*FR*CitationNotice of Availability: Final Guidance
			7/14/2009
			74FR34023Guidance
			7/14/2009

General Procedures and Policies for OTC Drug Products: Drug Review Procedures

Proposed Rule
			Date
			*FR* CitationProposed Rule: Review Procedures [PDF]
			1/5/1972
			37FR85Final Rule
			Date
			*FR* CitationFinal Rule: Review Procedures
			5/11/1972
			37FR9464Correction
			5/20/1972
			37FR10358Technical Amendment: Extend comment period for proposed rules to 90 days
			10/11/1977
			42FR54800

General Procedures and Policies for OTC Drug Products: Category III Active Ingredients

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking: Category III active ingredients become nonmonograph in final rule
			10/26/1979
			44FR61608Proposed Rule
			Date
			*FR* CitationProposed Rule: Continued marketing of Category III active ingredients until final rule
			10/21/1975
			40FR49097Proposed Rule: Category III active ingredients become nonmonograph in final rule
			5/13/1980
			45FR31422Final Rule
			Date
			*FR* CitationFinal Rule: Continued marketing of Category III active ingredients until final rule
			4/12/1977
			42FR19137Final Rule: Category III active ingredients become nonmonograph in final rule
			9/29/1981
			46FR47730

General Procedures and Policies for OTC Drug Products: Administrative Record

Proposed Rule
			Date
			*FR* CitationProposed Rule: Content and closing of administrative record
			6/4/1974
			39FR19878Final Rule
			Date
			*FR* CitationFinal Rule: Content and closing of administrative record
			11/8/1974
			39FR39556

General Procedures and Policies for OTC Drug Products: Miscellaneous Policies

Final Rule
			Date
			*FR* CitationNotice: Guideline available for OTC combination drug products
			11/28/1978
			43FR55466Notice: Miscellaneous policies (including feedback policy)
			9/29/1981
			46FR47740Notice: Economic impact analysis available
			2/8/1983
			48FR5806Notice: Policy on feedback letters
			4/1/1983
			48FR14050Notice: Policy on feedback meetings
			2/4/1985
			50FR4916Notice: Withdraws 136 NDAs and ANDAs
			3/4/2005
			70FR10651

General Procedures and Policies for OTC Drug Products: OTC/Prescription Dual Marketing

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationNotice: Public hearing
			4/27/2000
			65FR24704Advance Notice of Proposed Rulemaking
			9/1/2005
			70FR52050

                                                                                  Content current as of:
      03/02/2017Historical Status of OTC Rulemakings
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop