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Rulemaking History for OTC Otic Drug Products
View by Topic

Final Monograph (21 CFR part 344):  
Topical Otic Drug Products for Over-the-Counter Human Use

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Date Federal Register Citation Description
12/16/1977 42FR63556 PDF document Advance Notice of Proposed Rulemaking
12/12/1978 43FR18401 PDF document Correction: Advance Notice of Proposed Rulemaking
3/21/1980 45FR58097 PDF document Reopening of Administrative Record
7/9/1982 47FR30012 PDF document Tentative Final Monograph
8/13/1982 47FR35249 PDF document Correction: Tentative Final Monograph
7/30/1986 51FR27366 PDF document Proposed Rule: Includes labeling but no GRASE active ingredients for swimmer's ear and water-clogged ears
8/8/1986 51FR28656 PDF document Final Monograph
11/25/1986 51FR42676 PDF document Correction: 7/30/1986 Proposed Rule
3/13/1987 52FR7830 PDF document Correction: 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
1/30/1992 57FR3526 PDF document Technical Amendment: Correct an ingredient name (11/7/1990 Final Rule)
2/15/1995 60FR8916 PDF document
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Final Rule: No GRASE active ingredients for swimmer's ear and water-clogged ears
4/6/1995 60FR17611 PDF document
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Correction: 2/15/1995 Final Rule
4/28/1995 60FR20897 PDF document
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Correction: 2/15/1995 Final Rule
8/16/1995 60FR42435 PDF document
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Stay: Water-clogged ears (2/15/1995 Final Rule)
8/17/1999 64FR44671 PDF document
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Proposed Rule: Revises 2/15/1995 Final Rule to include labeling and GRASE active ingredient for water-clogged ears
8/10/2000 65FR48902 PDF document
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Final Rule: Includes labeling and GRASE active ingredients for water-clogged ears

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Date updated: December 28, 2006

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