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  7. Rulemaking History for OTC Boil Treatment Drug Products
  1. Status of OTC Rulemakings

Rulemaking History for OTC Boil Treatment Drug Products

Final Monograph (21 CFR 310.531):
Drug products containing active ingredients offered over-the-counter for the treatment of boils
 

OTC Boil Treatment Drug Products found on this page:

Boil Treatment Drug Products:Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]

6/29/1982

47FR28306
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]

1/26/1988

53FR2198
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Correct an ingredient name [PDF]1/30/199257FR3526
Final Monograph [PDF]

11/15/1993

58FR60332

Boil Treatment Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name [PDF]1/30/199257FR3526