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  6. Status of OTC Rulemakings
  7. Rulemaking History for OTC Antiperspirant Drug Products
  1. Status of OTC Rulemakings

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

8/20/1982

47FR36492
Final Rule Date FR Citation
Final Monograph 6/9/2003 68FR34273
    Partial Stay; Reopening of Administrative Record 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 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

Antiperspirant Drug Products: Zirconium

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

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