Rulemaking History for OTC Otic Drug Products

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

OTC Otic Drug Products found on this page:

Otic Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking 12/16/197742FR63556
    Correction 12/12/197843FR58097
    Reopening of Administrative Record3/21/198045FR18401
Proposed RuleDateFR Citation
Tentative Final Monograph7/9/198247FR30012
Final RuleDateFR Citation
Final Monograph8/8/198651FR28656

Otic Drug Products: Swimmer's Ear and Water-Clogged Ears

Proposed RuleDateFR Citation
Proposed Rule: Includes labeling but no GRASE active ingredients7/30/198651FR27366
Proposed Rule: Revises 2/15/1995 to include labeling and GRASE active ingredient for water-clogged ears8/17/199964FR44671
Final RuleDateFR Citation
Final Rule: No GRASE active ingredients2/15/199560FR8916
    Stay: Water-clogged ears8/16/199560FR42435
Final Rule: Includes labeling and GRASE active ingredients for water-clogged ears8/10/200065FR48902

Otic Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526


Page Last Updated: 01/19/2017
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