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  7. Rulemaking History for OTC Otic Drug Products
  1. Status of OTC Rulemakings

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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking  12/16/1977 42FR63556
    Correction  12/12/1978 43FR58097
    Reopening of Administrative Record 3/21/1980 45FR18401
Proposed Rule Date FR Citation
Tentative Final Monograph 7/9/1982 47FR30012
    Correction 8/13/1982 47FR35249
Final Rule Date FR Citation
Final Monograph 8/8/1986 51FR28656
    Correction 3/13/1987 52FR7830

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

Proposed Rule Date FR Citation
Proposed Rule: Includes labeling but no GRASE active ingredients 7/30/1986 51FR27366
    Correction 11/25/1986 51FR42676
Proposed Rule: Revises 2/15/1995 to include labeling and GRASE active ingredient for water-clogged ears 8/17/1999 64FR44671
Final Rule Date FR Citation
Final Rule: No GRASE active ingredients 2/15/1995 60FR8916
    Correction 4/6/1995 60FR17611
    Correction 4/28/1995 60FR20897
    Stay: Water-clogged ears 8/16/1995 60FR42435
Final Rule: Includes labeling and GRASE active ingredients for water-clogged ears 8/10/2000 65FR48902

Otic 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