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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 Dandruff, Seborrheic, Dermatitis and Psoriasis Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Dandruff, Seborrheic, Dermatitis and Psoriasis Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 358 subpart H)**:***Miscellaneous External Drug Products for Over-the-Counter Human Use: Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products*

OTC Dandruff, Seborrheic, Dermatitis and Psoriasis Drug Products found on this page:

Original Active Ingredients and Labeling
	Time and Extent Applications
	Coal Tar and Menthol
	Selenium Sulfide
	Nonmonograph Ingredients**Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvisory review panel change
			3/6/1979
			44FR12271Advance Notice Of Proposed Rulemaking
			12/3/1982
			47FR54646Correction
			2/8/1983
			48FR5761Extension of Comment Period
			2/8/1983
			48FR5762Correction
			2/28/1983
			48FR8261Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			7/30/1986
			51FR27346Correction
			11/25/1986
			51FR42676Extension of Comment Period
			10/1/1986
			51FR35003Proposed 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: Correct an ingredient name
			1/30/1992
			57FR3526Final Monograph
			12/4/1991
			56FR63554Correction
			1/17/1992
			57FR2136

**Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Time and Extent Applications**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: Piroctone olamine
			2/18/2004
			69FR7652Extension of Comment Period
			5/19/2004
			69FR28932Request for Data: Climbazole
			12/5/2005
			70FR72448Time and Extent Applications Proposed Rule Sodium Shale Oil Sulfonate
			4/7/2009
			74FR15741

**Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Coal Tar and Menthol**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds combination
			12/9/2005
			70FR73178Final Rule
			Date
			*FR* CitationFinal Rule
			3/6/2007
			72FR9849

**Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Selenium Sulfide**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds 0.6% micronized selenium sulfide
			4/5/1993
			58FR17554Final Rule
			Date
			*FR* CitationFinal Rule
			1/28/1994
			59FR4000

**Dandruff, Seborrheic, Dermatitis, and Psoriasis 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

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                                                                                  Content current as of:
      01/02/2020Historical Status of OTC Rulemakings
 
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