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 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 Category II and III Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Category II and III Drug Products
  
  	
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    PrintOTC Category II and III Drug Products found on this page:

Additional Ingredients
	Category III (Administrative Procedures)
	Other Ingredients
	Miscellaneous Drug Categories**Category II and III Active Ingredients in OTC Drug Products: Additional Ingredients**

Proposed Rule
			Date
			*FR* CitationProposed Rule: 21 OTC drug categories [PDF]
			5/16/1990
			55FR20434Correction [PDF]
			6/7/1990
			55FR23235Proposed Rule: 7 OTC drug categories [PDF]
			8/25/1992
			57FR38568Correction [PDF]
			9/8/1992
			57FR40944Technical Amendment: Corrects an ingredient name [PDF]
			10/1/1992
			57FR45295Correction [PDF]
			11/9/1992
			57FR53300Final Rule
			Date
			*FR* CitationFinal Rule: 19 OTC drug categories [PDF]
			11/7/1990
			55FR46914Correction [PDF]
			12/3/1990
			55FR49973Technical Amendment: Corrects several ingredient names [PDF]
			1/30/1992
			57FR3526Final Rule: 7 OTC drug categories [PDF]
			5/10/1993
			58FR27636Final Rule: Mercury compounds (first aid antiseptics, antimicrobial diaper rash, and vaginal contraceptive ingredients) [PDF]
			4/22/1998
			63FR19799

**Category II and III Drug Products: Category III (Administrative Procedures)**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationProposed Rule: Intent to revise procedures [PDF]
			10/26/1979
			44FR61608Proposed Rule
			Date
			*FR* CitationProposed Rule: Testing category 3 active ingredients [PDF]
			10/21/1975
			40FR49097Proposed Rule: Revises procedures [PDF]
			5/13/1980
			45FR31422Final Rule
			Date
			*FR* CitationFinal Rule: Testing category 3 Active Ingredients [PDF]
			4/12/1977
			42FR19137Final Rule: Revision of Procedures [PDF]
			9/29/1981
			46FR47730

**Category II and III Drug Products: Other Ingredients**

Final Rule
			Date
			*FR* CitationFinal Rule: Internal analgesic ingredients atropine and ephedrine [PDF]
			8/24/1998
			63FR44996Final Rule: Vaginal contraceptive ingredient octoxynol 9 [PDF]
			5/9/2002
			67FR31123Final Rule: Laxative ingredients *aloe* and *cascara sagrada* [PDF]
			5/9/2002
			67FR31125

**Category II and III Drug Products: Miscellaneous Drug Categories**

Advance Notice of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking: 60+ Drug Categories [PDF]
			12/31/2003
			68FR75585Proposed Rule: 60+ Drug Categories [PDF]
			6/19/2008
			73FR34895

                                                                                  Content current as of:
      01/01/2019Historical Status of OTC Rulemakings
 
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