Rulemaking History for OTC Antiperspirant Drug Products

Final Monograph (21 CFR part 350):
Antiperspirant Drug Products for Over-the-Counter Human Use 

OTC Antiperspirant Drug Products found on this page:

Antiperspirant Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]10/10/197843FR46694
    Correction [PDF]11/7/197843FR51806
    Correction [PDF]12/29/197843FR60957
Reopening of Administrative Record [PDF]3/21/198045FR18403
Request for Comments: Petitions regarding aluminum-containing products [PDF]3/23/199358FR15452
    Extension of Comment Period [PDF]7/19/199358FR38541
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]


Final RuleDateFR Citation
Final Monograph [PDF]6/9/200368FR34273
    Partial Stay; Reopening of Administrative Record [PDF]10/15/200469FR61148

Antiperspirant Drug Products: Nonmonograph Ingredients
Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph[PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name [PDF]1/30/199257FR3526

Antiperspirant Drug Products: Zirconium
Proposed RuleDateFR Citation
Proposed Rule: Classifies zirconium aerosols as nonmonograph [PDF]6/5/197540FR24328
    Correction [PDF]6/13/197540FR25218
    Extension of Comment Period [PDF]8/21/197540FR36574
Final RuleDateFR Citation
Final Rule [PDF]8/16/197742FR41374


Page Last Updated: 10/23/2014
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