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