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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 Topical Antimicrobial Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Topical Antimicrobial Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 333)**:***Topical Antimicrobial Drug Products for Over-the-Counter Human Use*

OTC Topical Antimicrobial Drug Products found on this page:

Alcohol
	Diaper Rash
	First Aid Antiseptic
	Healthcare Antiseptic
	Consumer Antiseptic
	Nonmonograph Ingredients
	Hexachlorophene
	Tribromsalan**Topical Antimicrobial Drug Products: Alcohol Original Indications**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			5/21/1982
			47FR22324

**Topical Antimicrobial Drug Products: Diaper Rash**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			9/7/1982
			47FR39406Correction
			12/7/1982
			47FR54981Extension of Comment Period
			12/28/1982
			47FR57738Proposed Rule
			Date
			*FR* CitationProposed Rule
			6/20/1990
			55FR25246

**Topical Antimicrobial Drug Products: First Aid Antiseptic**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			9/13/1974
			39FR33103Extension of Comment Period
			10/17/1974
			39FR37066Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			1/6/1978
			43FR1210Extension of Comment Period
			2/3/1978
			43FR4637Reopening of Administrative Record
			3/9/1979
			44FR13041Reopening of Administrative Record: Category II & III active ingredients
			10/26/1979
			44FR61609Reopening of Administrative Record
			3/21/1980
			45FR18398Proposed Rule: Establishes first aid separate from healthcare antiseptics
			7/22/1991
			56FR33644Correction
			1/9/1992
			57FR858Call for Data: Miscellaneous products
			12/31/2003
			68FR75585

**Topical Antimicrobial Drug Products: Healthcare Antiseptic**

Advance Notice of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			9/13/1974
			39FR33103Extension of Comment Period
			10/17/1974
			39FR37066Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			1/6/1978
			43FR1210Extension of Comment Period
			2/3/1978
			43FR4637Reopening of Administrative Record
			3/9/1979
			44FR13041Reopening of Administrative Record
			10/26/1979
			44FR61609Proposed Rule: Establishes healthcare separate from first aid antiseptics
			6/17/1994
			59FR31402Extension of Comment Period
			11/15/1994
			59FR58799Reopening of Administrative Record
			5/29/2003
			68FR32003Call for Data: Miscellaneous products
			12/31/2003
			68FR75585Notice: Public Hearing and Request for Comment
			11/21/2012
			77FR69863Proposed Rule: Establishes GRAS/E conditions for healthcare antiseptics
			5/1/2015
			80FR25166Final Rule: Finalizes rulemaking for healthcare antiseptics
			12/20/2017
			FR  12/20/2017

**Topical Antimicrobial Drug Products: Consumer Antiseptic**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			9/13/1974
			39FR33103Extension of Comment Period
			10/17/1974
			39FR37066Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			1/6/1978
			43FR1210Extension of Comment Period
			2/3/1978
			43FR4637Reopening of Administrative Record
			3/9/1979
			44FR13041Reopening of Administrative Record
			10/26/1979
			44FR61609Proposed Rule: Establishes healthcare separate from first aid antiseptics
			6/17/1994
			59FR31402Extension of Comment Period
			11/15/1994
			59FR58799Reopening of Administrative Record
			5/29/2003
			68FR32003Call for Data: Miscellaneous products
			12/31/2003
			68FR75585Proposed Rule:  Establishes consumer antiseptic washes separate from healthcare antiseptics
			12/17/2013
			78FR76444Proposed Rule: Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use (Consumer Antiseptic Rubs); Tentative Final Monograph
			6/29/2016
			81FR42911Final Rule: Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use (Consumer Antiseptic Washes); Final Monograph
			9/06/2016
			81FR61106Final Rule: Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use (Consumer Antiseptic Rubs); Final Monograph
			4/12/2019
			84FR14847

**Topical Antimicrobial Drug Products: Nonmonograph Ingredients**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph
			8/25/1992
			57FR38568Correction
			9/8/1992
			57FR40944Technical Amendment: Correct an ingredient name
			10/1/1992
			57FR45295Correction
			11/9/1992
			57FR53300Proposed Rule: 60+ Drug Categories
			6/19/2008
			73FR34895Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			4/22/1998
			63FR19799

**Topical Antimicrobial Drug Products: Hexachlorophene**

Proposed Rule
			Date
			*FR* CitationProposed Rule
			1/7/1972
			37FR219Request for Data: Hexachlorophene + 7 other ingredients
			1/7/1972
			37FR235Correction:1/7/1972 Request for Data
			1/26/1972
			37FR1182Final Rule
			Date
			*FR* CitationFinal Rule
			9/27/1972
			37FR20160Technical Amendment: Aerosol content determination
			11/4/1972
			37FR23537

**Topical Antimicrobial Drug Products: Tribromsalan**

Proposed Rule
			Date
			*FR* CitationProposed Rule:  Prohibits certain halogenated salicylanilides
			9/13/1974
			39FR33102Final Rule
			Date
			*FR* CitationFinal Rule
			10/30/1975
			40FR50527

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                                                                                  Content current as of:
      01/08/2020
              
              
Regulated Product(s)
		 DrugsHistorical Status of OTC Rulemakings
 
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