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