Rulemaking History for OTC Ophthalmic Drug Products

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

OTC Ophthalmic Drug Products found on this page:

Ophthalmic Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
 Advance Notice of Proposed Rulemaking 5/6/198045FR30002
Proposed RuleDateFR Citation
 Tentative Final Monograph6/28/1983 48FR29788
     Correction7/19/1983 48FR32837
     Reopening of Administrative Record: Yellow mercuric oxide (anti-infective) excluded from
     final monograph
Final RuleDateFR Citation
 Final Monograph3/4/1988 53FR7076 
     Technical Amendment: Revises "hydroxypropyl methylcellulose" to "hypromellose"6/3/200368FR32981
     Technical Amendment: Clarifies Labeling of Active/Inactive Ingredients2/19/200368FR7919

Ophthalmic Drug Products: Emergency First Aid Eyewashes

Advance Notice Of Proposed RulemakingDateFR Citation
 Request or Data12/5/198954FR50240
Proposed RuleDateFR Citation
 Proposed Rule2/19/200368FR7951
Final RuleDateFR Citation

Ophthalmic Drug Products: Contact Lens Solution

Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Reclassifies contact lens solution from OTC drug to device3/6/197944FR12270

Ophthalmic Drug Products: Vasoconstrictor Warning

Proposed Amendment of Final MonographDateFR Citation
Proposed Amendment of Final Monograph2/23/199863FR8888
Amendment of Final MonographDateFR Citation
Amendment of Final Monograph6/21/200065FR38426

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Page Last Updated: 07/24/2017
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