Drugs

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 Rulemaking11/3/197843FR51546disclaimer icon
    Reopening of Administrative Record3/21/198045FR18404disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph: Classifies hydroquinone as only GRASE active ingredient9/3/198247FR39108disclaimer icon
    Correction11/19/198247FR52200disclaimer icon
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434disclaimer icon
    Correction6/7/199055FR23235disclaimer icon
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 nonmonograph11/7/199055FR46914disclaimer icon
    Correction12/3/199055FR49973disclaimer icon
    Technical Amendment: Correct an ingredient name1/30/199257FR3526disclaimer icon

Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434disclaimer icon
   Correction6/7/199055FR23235disclaimer icon
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914disclaimer icon
    Correction12/3/199055FR49973disclaimer icon
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526disclaimer icon

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Page Last Updated: 02/23/2017
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