U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Status of OTC Rulemakings
  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
Proposed RuleDateFR Citation
Tentative Final Monograph4/3/198954FR13480
Final RuleDateFR Citation
Final Monograph12/14/199358FR65452
    Technical Amendment: Requires pyrethrin concentration be stated for pyrethrum extracts8/13/199863FR43302
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
    Technical Amendment: Correct an ingredient name10/1/199257FR45295
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