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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for General Procedures and Policies for OTC Drug Products

General Procedures and Policies for OTC Drug Products found on this page:


General Procedures and Policies for OTC Drug Products: Adverse Event Reporting
 Proposed RuleDateFR Citation
Notice of Availability: Draft Guidance [PDF]10/15/200772FR58316
         Guidance [PDF]10/15/2007 
Final RuleDateFR Citation
Notice of Availability: Final Guidance [PDF]7/14/200974FR34023
         Guidance [PDF]7/14/2009 

General Procedures and Policies for OTC Drug Products: Drug Review Procedures
Proposed RuleDateFR Citation
Proposed Rule: Review Procedures [PDF]1/5/197237FR85
Final RuleDateFR Citation
Final Rule: Review Procedures [PDF]5/11/197237FR9464
          Correction [PDF]5/20/197237FR10358
Technical Amendment: Extend comment period for proposed rules to 90 days [PDF]10/11/197742FR54800

General Procedures and Policies for OTC Drug Products: Category III Active Ingredients
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking: Category III active ingredients become nonmonograph in final rule [PDF]10/26/197944FR61608
Proposed RuleDateFR Citation
Proposed Rule: Continued marketing of Category III active ingredients until final rule [PDF]10/21/197540FR49097
Proposed Rule: Category III active ingredients become nonmonograph in final rule [PDF]5/13/198045FR31422
Final RuleDateFR Citation
Final Rule: Continued marketing of Category III active ingredients until final rule [PDF]4/12/197742FR19137
Final Rule: Category III active ingredients become nonmonograph in final rule [PDF]9/29/198146FR47730

General Procedures and Policies for OTC Drug Products: Administrative Record
Proposed RuleDateFR Citation
Proposed Rule: Content and closing of administrative record [PDF]6/4/197439FR19878
Final RuleDateFR Citation
Final Rule: Content and closing of administrative record [PDF]11/8/197439FR39556

General Procedures and Policies for OTC Drug Products: Miscellaneous Policies
Final RuleDateFR Citation
Notice: Guideline available for OTC combination drug products [PDF]11/28/197843FR55466
Notice: Miscellaneous policies (including feedback policy) [PDF]9/29/198146FR47740
Notice: Economic impact analysis available [PDF]2/8/198348FR5806
Notice: Policy on feedback letters [PDF]4/1/198348FR14050
Notice: Policy on feedback meetings [PDF]2/4/198550FR4916
Notice: Withdraws 136 NDAs and ANDAs [PDF]3/4/200570FR10651

General Procedures and Policies for OTC Drug Products: OTC/Prescription Dual Marketing
Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Public hearing [PDF]4/27/200065FR24704
Advance Notice of Proposed Rulemaking [PDF]9/1/200570FR52050