Drugs
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Rulemaking History for OTC Otic Drug Products
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Final Monograph (21 CFR part 344): |
OTC Otic Drug Products found on this page:
- Original Active Ingredients and Labeling
- Swimmer's Ear and Water-Clogged Ears
- Nonmonograph Ingredients
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 12/16/1977 | 42FR63556 |
| Correction [PDF] | 12/12/1978 | 43FR58097 |
| Reopening of Administrative Record [PDF] | 3/21/1980 | 45FR18401 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 7/9/1982 | 47FR30012 |
| Correction [PDF] | 8/13/1982 | 47FR35249 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 8/8/1986 | 51FR28656 |
| Correction [PDF] | 3/13/1987 | 52FR7830 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Includes labeling but no GRASE active ingredients [PDF] | 7/30/1986 | 51FR27366 |
| Correction [PDF] | 11/25/1986 | 51FR42676 |
| Proposed Rule: Revises 2/15/1995 to include labeling and GRASE active ingredient for water-clogged ears [PDF] | 8/17/1999 | 64FR44671 |
| Final Rule | Date | FR Citation |
| Final Rule: No GRASE active ingredients [PDF] | 2/15/1995 | 60FR8916 |
| Correction [PDF] | 4/6/1995 | 60FR17611 |
| Correction [PDF] | 4/28/1995 | 60FR20897 |
| Stay: Water-clogged ears [PDF] | 8/16/1995 | 60FR42435 |
| Final Rule: Includes labeling and GRASE active ingredients for water-clogged ears [PDF] | 8/10/2000 | 65FR48902 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 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 [PDF] | 11/7/1990 | 55FR46914 |
| Correction [PDF] | 12/3/1990 | 55FR49973 |
| Technical Amendment: Corrects an ingredient name [PDF] | 1/30/1992 | 57FR3526 |
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