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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Pediculicide Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Pediculicide Drug Products

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:

Pediculicide Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 6/29/1982 47FR28314
    Correction 8/6/1982 47FR34166
Proposed Rule Date FR Citation
Tentative Final Monograph 4/3/1989 54FR13480
    Correction 4/27/1989 54FR18197
Final Rule Date FR Citation
Final Monograph 12/14/1993 58FR65452
    Technical Amendment: Requires pyrethrin concentration be stated for pyrethrum extracts 8/13/1998 63FR43302
         Correction 9/1/1998 63FR46389
Notice: Response to petitions concerning EPA jurisdiction 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 8/25/1992 57FR38568
    Correction 9/8/1992 57FR40944
    Technical Amendment: Correct an ingredient name 10/1/1992 57FR45295
    Correction 11/9/1992 57FR53300
Final Rule Date FR Citation
Final 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 Citation
Proposed Rule:  Revises labeling to comply with Drug Facts 5/10/2002 67FR31739
Final Rule Date FR Citation
Final Rule 12/31/2003 68FR75414
 
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