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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 Acne Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History  for OTC Acne Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 333 subpart D)*Topical Anti-Microbial Drug Products for Over-the-Counter Human Use*

OTC Acne Drug Products found on this page:

Original Active Ingredients & Labeling
	Benzoyl Peroxide
	Nonmonograph Ingredients
	Time and Extent ApplicationAcne Drug Products: Original Active Ingredients & Labeling

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			3/23/1982
			47FR12430Correction
			4/23/1982
			47FR17575Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			1/15/1985
			50FR2172Final Rule
			Date
			*FR* CitationFinal Monograph
			8/16/1991
			56FR41008

Acne Drug Products: Benzoyl Peroxide

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			3/23/1982
			47FR12430Correction
			4/23/1982
			47FR17575Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			1/15/1985
			50FR2172Proposed Rule: Reclassifies benzoyl peroxide from GRASE to Category III
			8/7/1991
			56FR37622Correction
			10/8/1991
			56FR50754Proposed Rule: Additional labeling
			2/17/1995
			60FR9554Extension of Comment Period
			5/19/1995
			60FR26853Final Rule
			Date
			*FR* CitationFinal Monograph
			3/4/2010
			75FR9767

Acne Drug Products: Nonmonograph Ingredients

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph
			5/16/1990
			55FR20434Correction
			6/7/1990
			55FR23235Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			11/7/1990
			55FR46914Correction
			12/3/1990
			55FR49973Technical Amendment: Corrects an ingredient name
			1/30/1992
			57FR3526

Acne Drug Products: Time and Extent Application

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: triclosan
			12/5/2005
			70FR72447

                                                                                  Content current as of:
      05/02/2018Historical Status of OTC Rulemakings
 
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