Drugs
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Rulemaking History for OTC Ophthalmic Drug Products
Final Monograph (21 CFR part 349): |
OTC Ophthalmic Drug Products found on this page:
- Original Active Ingredients and Labeling
- Emergency First Aid Eyewashes
- Contact Lens Solution
- Vasoconstrictor Warning
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 5/6/1980 | 45FR30002 |
| Correction [PDF] | 7/22/1980 | 45FR48920 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 6/28/1983 | 48FR29788 |
| Correction [PDF] | 7/19/1983 | 48FR32837 |
| Reopening of Administrative Record: Yellow mercuric oxide (anti-infective) excluded from final monograph [PDF] | 3/4/1988 | 53FR6997 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 3/4/1988 | 53FR7076 |
| Correction [PDF] | 4/21/1988 | 53FR13217 |
| Technical Amendment: Revises "hydroxypropyl methylcellulose" to "hypromellose" [PDF] | 6/3/2003 | 68FR32981 |
| Technical Amendment: Clarifies Labeling of Active/Inactive Ingredients [PDF] | 2/19/2003 | 68FR7919 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Request for Data [PDF] | 12/5/1989 | 54FR50240 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule [PDF] | 2/19/2003 | 68FR7951 |
| Final Rule | Date | FR Citation |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Notice: Reclassifies contact lens solution from OTC drug to device [PDF] | 3/6/1979 | 44FR12270 |
| Proposed Amendment of Final Monograph | Date | FR Citation |
|---|---|---|
| Proposed Amendment of Final Monograph [PDF] | 2/23/1998 | 63FR8888 |
| Amendment of Final Monograph | Date | FR Citation |
| Amendment of Final Monograph [PDF] | 6/21/2000 | 65FR38426 |
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