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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

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Date Federal Register Citation Description
3/6/1979 44FR12270 PDF document Notice: Classifies contact lens solution is device (not drug)
5/6/1980 45FR30002 PDF document Advance Notice of Proposed Rulemaking
7/22/1980 45FR48920 PDF document Correction: Advance Notice of Proposed Rulemaking
6/28/1983 48FR29788 PDF document Tentative Final Monograph
7/19/1983 48FR32837 PDF document Correction: Tentative Final Monograph
3/4/1988 53FR6997 PDF document Reopening of Administrative Record: Yellow mercuric oxide (anti-infective) excluded from final monograph
3/4/1988 53FR7076 PDF document Final Monograph
4/21/1988 53FR13217 PDF document
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Correction: Final Monograph
12/5/1989 54FR50240 PDF document
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Request for Data: Emergency first aid eyewashes
2/19/2003 68FR7951 PDF document
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Proposed Rule: Emergency first aid eyewashes
2/19/2003 68FR7919 PDF document
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Technical Amendment: Incorporates emergency first aid eyewashes in monograph
6/3/2003 68FR32981 PDF document
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Technical Amendment: Revises "hydroxypropyl methylcellulose" to "hypromellose"

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Date updated: December 28, 2006; April 12, 2007

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