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:

• Original Active Ingredients and Labeling
• Swimmer's Ear and Water-Clogged Ears
• Nonmonograph Ingredients

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