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  7. Rulemaking History for OTC Skin Bleaching Drug Products
  1. Status of OTC Rulemakings

Rulemaking History for OTC Skin Bleaching Drug Products

Pending Final Monograph (21 CFR part 358 subpart A):
Miscellaneous External Drug Products for Over-the-Counter Human Use: Skin Bleaching Drug Products

OTC Skin Bleaching Drug Products found on this page:

Skin Bleaching Drug Products : Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking11/3/197843FR51546
    Reopening of Administrative Record3/21/198045FR18404
Proposed RuleDateFR Citation
Tentative Final Monograph: Classifies hydroquinone as only GRASE active ingredient9/3/198247FR39108
    Correction11/19/198247FR52200
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
    Correction6/7/199055FR23235
Proposed Rule: Reclassifies hydroquinone as nonmonograph; withdraws tentative final monograph8/29/200671FR51146
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction12/3/199055FR49973
    Technical Amendment: Correct an ingredient name1/30/199257FR3526

Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
   Correction6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526

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