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U.S. Department of Health and Human Services

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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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 11/3/1978 43FR51546
    Reopening of Administrative Record [PDF] 3/21/1980 45FR18404
Proposed Rule Date FR Citation
Tentative Final Monograph: Classifies hydroquinone as only GRASE active ingredient [PDF] 9/3/1982 47FR39108
    Correction [PDF] 11/19/1982 47FR52200
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Proposed Rule: Reclassifies hydroquinone as nonmonograph; withdraws tentative final monograph [PDF] 8/29/2006 71FR51146
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

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