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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Pediculicide Drug Products

Final Monograph (21 CFR part 358 subpart G):  
Miscellaneous External Drug Products for Over-the-Counter Human Use: Pediculicide Drug Products 

OTC Pediculicide Drug Products found on this page:


Pediculicide Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 6/29/1982 47FR28314
    Correction [PDF] 8/6/1982 47FR34166
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 4/3/1989 54FR13480
    Correction [PDF] 4/27/1989 54FR18197
Final Rule Date FR Citation
Final Monograph [PDF] 12/14/1993 58FR65452
    Technical Amendment: Requires pyrethrin concentration be stated for pyrethrum extracts [PDF] 8/13/1998 63FR43302
         Correction [PDF] 9/1/1998 63FR46389
Notice: Response to petitions concerning EPA jurisdiction [PDF] 12/6/1994 59FR62569
 
Pediculicide Drug Products: Nonmonograph Ingredients
Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 8/25/1992 57FR38568
    Correction [PDF] 9/8/1992 57FR40944
    Technical Amendment: Correct an ingredient name [PDF] 10/1/1992 57FR45295
    Correction [PDF] 11/9/1992 57FR53300
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/10/1993 58FR27636
 
Pediculicide Drug Products: Drug Facts Labeling
Proposed Rule Date FR Citation
Proposed Rule:  Revises labeling to comply with Drug Facts [PDF] 5/10/2002 67FR31739
Final Rule Date FR Citation
Final Rule [PDF] 12/31/2003 68FR75414
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