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 Weight Control Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Weight Control Drug Products
  
  	
    Share
    Post
    Linkedin

    Email
    Print**Final Monograph**(21 CFR 310.545(a)(20)):*Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses*

OTC Weight Control Drug Products found on this page:

Benzocaine
	Original Active Ingredients and Labeling
	Nonmonograph Ingredients
	Phenylpropanolamine (PPA)
	Water-Soluble Gums**Weight Control Drug Products: Benzocaine**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			2/26/1982
			47FR8466Correction
			4/20/1982
			47FR16796Correction
			4/27/1982
			47FR18004Proposed Rule
			Date
			*FR* CitationProposed Rule: Proposes to reclassify benzocaine as nonmonograph
			3/9/2011
			76FR12916

**Weight Control Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			2/26/1982
			47FR8466Correction
			4/20/1982
			47FR16796Correction
			4/27/1982
			47FR18004Extension of Comment Period: Phenylpropanolamine safety
			4/23/1982
			47FR17576Notice: Combinations containing caffeine, phenylpropanolamine, and ephedrine are nonmonograph
			8/13/1982
			47FR35344Notice: Combinations containing caffeine, phenylpropanolamine, and ephedrine are nonmonograph
			11/18/1983
			48FR52513Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			10/30/1990
			55FR45788Correction
			11/26/1990
			55FR49200Final Rule
			Date
			*FR* CitationFinal Monograph: No GRASE active ingredients
			8/8/1991
			56FR37792Correction
			9/16/1991
			56FR46823

**Weight Control Drug Products: Nonmonograph Ingredients**

Proposed Rule
			Date
			*FR* CitationProposed Rule: 60+ Drug Categories
			6/19/2008
			73FR34895

**Weight Control Drug Products: Phenylpropanolamine (PPA)**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			2/26/1982
			47FR8466Correction
			4/20/1982
			47FR16796Correction
			4/27/1982
			47FR18004Extension of Comment Period: Phenylpropanolamine safety
			4/23/1982
			47FR17576Reopening of Administrative Record: Advisory Committee meeting
			4/1/1991
			56FR13295Correction
			4/11/1991
			56FR14730Extension of Comment Period
			8/13/1991
			56FR38391Notice: Advisory Committee meeting
			8/30/2000
			65FR52775Proposed Rule
			Date
			*FR* CitationProposed Rule: Reclassifies phenylpropanolamine from category I to II
			12/22/2005
			70FR75988

**Weight Control Drug Products: Water-Soluble Gums**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Requires choking warning
			10/30/1990
			55FR45782Correction
			11/27/1990
			55FR49377Clarification: Guar gums remain nonmonograph
			3/6/1991
			56FR9312Final Rule
			Date
			*FR* CitationFinal Rule
			8/26/1993
			58FR45194Back to Top

                                                                                  Content current as of:
      01/08/2020Historical 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