Rulemaking History for OTC Ophthalmic Drug Products

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Rulemaking History for OTC Ophthalmic Drug Products
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Final Monograph (21 CFR part 349):
Ophthalmic Drug Products for Over-the-Counter Human Use

OTC Ophthalmic Drug Products found on this page:

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**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

**Ophthalmic Drug Products: Emergency First Aid Eyewashes**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data	12/5/1989	54FR50240
Proposed Rule	Date	FR Citation
Proposed Rule	2/19/2003	68FR7951
Final Rule	Date	FR Citation
Technical Amendment: Incorporates emergency first aid eyewashes in monograph	2/19/2003	68FR7919

**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

Date created: December 28, 2006; Last updated: May 4, 2007