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Rulemaking History for OTC Antiperspirant Drug Products
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Final Monograph (21 CFR part 350):  
Antiperspirant Drug Products for Over-the-Counter Human Use


Date Federal Register Citation Description
6/5/1975

40FR24328 PDF document

Proposed Rule: Classified zirconium aerosols as nonmonograph
6/13/1975

40FR25218 PDF document

Correction: 6/5/1975 Proposed Rule
8/21/1975

40FR36574 PDF document

Extension of Comment Period: 6/5/1975 Proposed Rule
8/16/1977

42FR41374 PDF document

Final Rule: Classified zirconium aerosols as nonmonograph
10/10/1978

43FR46694 PDF document

Advance Notice of Proposed Rulemaking

11/7/1978

43FR51806 PDF document

Correction: Advance Notice of Proposed Rulemaking
12/29/1978

43FR60957 PDF document

Correction: Advance Notice of Proposed Rulemaking
3/21/1980

45FR18403 PDF document

Reopening of Administrative Record
8/20/1982

47FR36492 PDF document

Tentative Final Monograph
5/16/1990 55FR20434 PDF document Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
6/7/1990 55FR23235 PDF document Correction: 5/16/1900 Proposed Rule
11/7/1990 55FR46914 PDF document Final Rule: Classifies category II and III ingredients without data as nonmonograph
12/3/1990 55FR49973 PDF document Correction: 11/7/1990 Final Rule
1/30/1992 57FR3526 PDF document Technical Amendment: Corrects an ingredient name (11/7/1990 Final Rule)
3/23/1993

58FR15452 PDF document

Request for Comments: Petitions regarding aluminum-containing products
7/19/1993

58FR38541 PDF document

Extension of Comment Period: Request for Comments

6/9/2003

68FR34273 PDF document
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Final Monograph

10/15/2004 69FR61148 PDF document
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Partial Stay; Reopening of the Administrative Record: Final Monograph

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Date updated: May 8, 2007

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