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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 Pediculicide Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Pediculicide Drug Products
  
  	
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    Print**Final Monograph**(21 CFRpart 358 subpart G)**:*****Miscellaneous External Drug Products for Over-the-Counter Human Use: Pediculicide Drug Products*

OTC Pediculicide Drug Products found on this page:

Original Active Ingredients and Labeling
	Nonmonograph Ingredients
	Drug Facts Labeling**Pediculicide Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			6/29/1982
			47FR28314Correction
			8/6/1982
			47FR34166Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			4/3/1989
			54FR13480Correction
			4/27/1989
			54FR18197Final Rule
			Date
			*FR* CitationFinal Monograph
			12/14/1993
			58FR65452Technical Amendment: Requires pyrethrin concentration be stated for pyrethrum extracts
			8/13/1998
			63FR43302Correction
			9/1/1998
			63FR46389Notice: Response to petitions concerning EPA jurisdiction
			12/6/1994
			59FR62569**Pediculicide 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**Pediculicide Drug Products: Drug Facts Labeling**

Proposed Rule
			Date
			*FR* CitationProposed Rule:  Revises labeling to comply with Drug Facts
			5/10/2002
			67FR31739Final Rule
			Date
			*FR* CitationFinal Rule
			12/31/2003
			68FR75414

                                                                                  Content current as of:
      10/03/2017Historical Status of OTC Rulemakings
 
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