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Rulemaking History for OTC Acne Drug Products
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Final Monograph (21 CFR part 333 subpart D):  
Topical Anti-Microbial Drug Products for Over-the-Counter Human Use
 


Date Federal Register Citation Description
2/23/1982 47FR12430 PDF document Advance Notice of Proposed Rulemaking
4/23/1982 47FR17575 PDF document Correction: Advance Notice of Proposed Rulemaking
1/15/1985 50FR2172 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: 5/16/1990 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
8/7/1991 56FR37622 PDF document Proposed Rule: Reclassifes benzoyl peroxide as Category III
8/16/1991 56FR41008 PDF document Final Monograph
10/8/1991 56FR50754 PDF document Correction: 8/7/1991 Proposed Rule
1/30/1992 57FR3526 PDF document Technical Amendment: Corrects an ingredient name (11/7/1990 Final Rule)
2/17/1995 60FR9554 PDF document
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Proposed Rule: Labeling for benzoyl peroxide 
5/19/1995 60FR26853 PDF document
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Extension of comment period: 2/17/1995 Proposed Rule
12/5/2005 70FR72447 PDF document
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Request for data: triclosan

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Date updated: May 9, 2007

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