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                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 Anorectal Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Anorectal Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 346)**:***Anorectal Drug Products for Over-the-Counter Human Use*



OTC Anorectal Drug Products found on this page:

Original Active Ingredients & Labeling
	Sodium Labeling**Anorectol Drug Products: Original Active Ingredients & Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking [PDF]
			5/27/1980
			45FR35576Correction [PDF]
			7/22/1980
			45FR48920Correction [PDF]
			8/15/1980
			45FR54354Reopening of Administrative Record: Camphor-containing products [PDF]
			9/26/1980
			45FR63876Proposed Rule
			Date
			*FR* CitationTentative Final Monograph [PDF]
			8/15/1988
			53FR30756Final Rule
			Date
			*FR* CitationFinal Monograph [PDF]
			8/3/1990
			55FR31776Technical Amendment: Live yeast cell derivative (LYCD) [PDF]
			9/2/1993
			58FR46746Technical Amendment: USP name change ("Hamamelis water" to "witch hazel") [PDF]
			6/3/1994
			59FR28766Technical Amendment: Combination of hydrocortisone and pramoxine hydrochloride is nonmonograph [PDF]
			8/26/2003
			68FR51167

**Anorectal Drug Products: Sodium Labeling**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Sodium phosphate-containing products [PDF]
			3/24/2004
			69FR13765Final Rule
			Date
			*FR* CitationFinal Rule [PDF]
			11/29/2004
			69FR69278

                                                                                  Content current as of:
      02/04/2020Historical Status of OTC Rulemakings
 
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