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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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF]

6/29/1982

47FR28306
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF]

1/26/1988

53FR2198
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Correct an ingredient name [PDF] 1/30/1992 57FR3526
Final Monograph [PDF]

11/15/1993

58FR60332

Boil Treatment Drug Products: Nonmonograph Ingredients

Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Corrects an ingredient name [PDF] 1/30/1992 57FR3526