Drugs

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 Rulemaking10/10/197843FR46694
    Correction11/7/197843FR51806
    Correction12/29/197843FR60957
Reopening of Administrative Record3/21/198045FR18403
Request for Comments: Petitions regarding aluminum-containing products3/23/199358FR15452
    Extension of Comment Period7/19/199358FR38541
Proposed RuleDateFR Citation
Tentative Final Monograph

8/20/1982

47FR36492
Final RuleDateFR Citation
Final Monograph6/9/200368FR34273
    Partial Stay; Reopening of Administrative Record10/15/200469FR61148

Antiperspirant 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

Antiperspirant Drug Products: Zirconium

Proposed RuleDateFR Citation
Proposed Rule: Classifies zirconium aerosols as nonmonograph6/5/197540FR24328
    Correction6/13/197540FR25218
    Extension of Comment Period8/21/197540FR36574
Final RuleDateFR Citation
Final Rule8/16/197742FR41374

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Page Last Updated: 04/24/2017
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