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 OTC Skin Bleaching Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Skin Bleaching Drug Products
  
  	
    Share
    Post
    Linkedin

    Email
    Print**Pending Final Monograph**(21 CFR part 358 subpart A)**:***Miscellaneous External Drug Products for Over-the-Counter Human Use: Skin Bleaching Drug Products*OTC Skin Bleaching Drug Products found on this page:Original Active Ingredients and LabelingNonmonograph Ingredients**Skin Bleaching Drug Products : Original Active Ingredients and Labeling**Advance Notice Of Proposed RulemakingDate*FR* CitationAdvance Notice of Proposed Rulemaking11/3/197843FR51546Reopening of Administrative Record3/21/198045FR18404Proposed RuleDate*FR* CitationTentative Final Monograph: Classifies hydroquinone as only GRASE active ingredient9/3/198247FR39108Correction11/19/198247FR52200Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434Correction6/7/199055FR23235Proposed Rule: Reclassifies hydroquinone as nonmonograph; withdraws tentative final monograph8/29/200671FR51146Final RuleDate*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914Correction12/3/199055FR49973Technical Amendment: Correct an ingredient name1/30/199257FR3526**Drug Products: Nonmonograph Ingredients**Proposed RuleDate*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434Correction6/7/199055FR23235Final RuleDate*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914Correction12/3/199055FR49973Technical Amendment: Corrects an ingredient name1/30/199257FR3526Back to Top

                                                                                  Content current as of:
      10/04/2017Historical 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