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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 Menstrual Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Menstrual Drug Products
  
  	
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    Print**Pending Final Monograph**(21 CFR part 357 subpart K)**:*****Miscellaneous Internal Drug Products for Over-the-Counter Human Use*

FDA Archive-It webpage:
Rulemaking History for OTC Menstrual Drug ProductsSearch for Federal Register documents:

GPO Federal Register Database (1994 to present)
	HeinOnline provides online access to Federal Registers from 1936-forward

OTC Menstrual Drug Products found on this page:

Original Active Ingredients and Labeling
	Nonmonograph Ingredients**Menstrual Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice Of Proposed Rulemaking
			12/7/1982
			47FR55076Correction
			1/14/1983
			48FR1758Correction
			2/18/1983
			48FR7202Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			11/16/1988
			53FR46194Correction
			1/18/1989
			54FR2039Proposed 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
			57FR53300Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			5/10/1993
			58FR27636

**Menstrual 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
			57FR53300Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			5/10/1993
			58FR27636

                                                                                  Content current as of:
      07/12/2017Historical Status of OTC Rulemakings
 
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