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U.S. Department of Health and Human Services

Drugs

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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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 10/10/1978 43FR46694
    Correction [PDF] 11/7/1978 43FR51806
    Correction [PDF] 12/29/1978 43FR60957
Reopening of Administrative Record [PDF] 3/21/1980 45FR18403
Request for Comments: Petitions regarding aluminum-containing products [PDF] 3/23/1993 58FR15452
    Extension of Comment Period [PDF] 7/19/1993 58FR38541
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF]

8/20/1982

47FR36492
Final Rule Date FR Citation
Final Monograph [PDF] 6/9/2003 68FR34273
    Partial Stay; Reopening of Administrative Record [PDF] 10/15/2004 69FR61148

Antiperspirant 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

Antiperspirant Drug Products: Zirconium
Proposed Rule Date FR Citation
Proposed Rule: Classifies zirconium aerosols as nonmonograph [PDF] 6/5/1975 40FR24328
    Correction [PDF] 6/13/1975 40FR25218
    Extension of Comment Period [PDF] 8/21/1975 40FR36574
Final Rule Date FR Citation
Final Rule [PDF] 8/16/1977 42FR41374