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U.S. Department of Health and Human Services

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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 [PDF]5/6/198045FR30002
    Correction [PDF]7/22/198045FR48920
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]6/28/198348FR29788
     Correction [PDF]7/19/198348FR32837
    Reopening of Administrative Record: Yellow mercuric oxide (anti-infective) excluded from final monograph [PDF]3/4/198853FR6997
Final RuleDateFR Citation
Final Monograph [PDF]3/4/198853FR7076
    Correction [PDF]4/21/198853FR13217
    Technical Amendment: Revises "hydroxypropyl methylcellulose" to "hypromellose" [PDF]6/3/200368FR32981
    Technical Amendment: Clarifies Labeling of Active/Inactive Ingredients [PDF]2/19/200368FR7919

Ophthalmic Drug Products: Emergency First Aid Eyewashes
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data [PDF]12/5/198954FR50240
Proposed RuleDateFR Citation
Proposed Rule [PDF]2/19/200368FR7951
Final RuleDateFR Citation
   

Ophthalmic Drug Products: Contact Lens Solution
Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Reclassifies contact lens solution from OTC drug to device [PDF]3/6/197944FR12270


Ophthalmic Drug Products: Vasoconstrictor Warning
Proposed Amendment of Final MonographDateFR Citation
Proposed Amendment of Final Monograph [PDF]2/23/199863FR8888
Amendment of Final MonographDateFR Citation
Amendment of Final Monograph [PDF]6/21/200065FR38426