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