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Rulemaking History for OTC Skin Bleaching Drug Products
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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:

Note: This page links to PDF files which require the free Adobe Acrobat Reader.


Skin Bleaching Drug Products : Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 11/2/1978 43FR51546
    Reopening of Administrative Record 3/21/1980 45FR18404
Proposed Rule Date FR Citation
Tentative Final Monograph: Classifies hydroquinone as only GRASE active ingredient 9/3/1982 47FR39108
    Correction 11/19/1982 47FR52200
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph 5/16/1990 55FR20434
    Correction 6/7/1990 55FR23235
Proposed Rule: Reclassifies hydroquinone as nonmonograph; withdraws tentative final monograph 8/29/2006 71FR51146
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph 11/7/1990 55FR46914
    Correction 12/3/1990 55FR49973
    Technical Amendment: Correct an ingredient name 1/30/1992 57FR3526
Drug Products: Nonmonograph Ingredients

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

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Date created: December 28, 2006; Last updated: April 30, 2007

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