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  7. Rulemaking History for OTC Pediculicide Drug Products
  1. 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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking6/29/198247FR28314
    Correction8/6/198247FR34166
Proposed RuleDateFR Citation
Tentative Final Monograph4/3/198954FR13480
    Correction4/27/198954FR18197
Final RuleDateFR Citation
Final Monograph12/14/199358FR65452
    Technical Amendment: Requires pyrethrin concentration be stated for pyrethrum extracts8/13/199863FR43302
         Correction9/1/199863FR46389
Notice: Response to petitions concerning EPA jurisdiction12/6/199459FR62569

Pediculicide Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph8/25/199257FR38568
    Correction9/8/199257FR40944
    Technical Amendment: Correct an ingredient name10/1/199257FR45295
    Correction11/9/199257FR53300
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph5/10/199358FR27636

Pediculicide Drug Products: Drug Facts Labeling

Proposed RuleDateFR Citation
Proposed Rule:  Revises labeling to comply with Drug Facts5/10/200267FR31739
Final RuleDateFR Citation
Final Rule12/31/200368FR75414