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  7. Rulemaking History for General Procedures and Policies for OTC Drug Products
  1. Status of OTC Rulemakings

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 Guidance10/15/200772FR58316
        Guidance10/15/2007 
Final RuleDateFR Citation
Notice of Availability: Final Guidance7/14/200974FR34023
        Guidance7/14/2009 

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 Procedures5/11/197237FR9464
        Correction5/20/197237FR10358
Technical Amendment: Extend comment period for proposed rules to 90 days10/11/197742FR54800

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 rule10/26/197944FR61608
Proposed RuleDateFR Citation
Proposed Rule: Continued marketing of Category III active ingredients until final rule10/21/197540FR49097
Proposed Rule: Category III active ingredients become nonmonograph in final rule5/13/198045FR31422
Final RuleDateFR Citation
Final Rule: Continued marketing of Category III active ingredients until final rule4/12/197742FR19137
Final Rule: Category III active ingredients become nonmonograph in final rule9/29/198146FR47730

General Procedures and Policies for OTC Drug Products: Administrative Record

Proposed RuleDateFR Citation
Proposed Rule: Content and closing of administrative record6/4/197439FR19878
Final RuleDateFR Citation
Final Rule: Content and closing of administrative record11/8/197439FR39556

General Procedures and Policies for OTC Drug Products: Miscellaneous Policies

Final RuleDateFR Citation
Notice: Guideline available for OTC combination drug products11/28/197843FR55466
Notice: Miscellaneous policies (including feedback policy)9/29/198146FR47740
Notice: Economic impact analysis available2/8/198348FR5806
Notice: Policy on feedback letters4/1/198348FR14050
Notice: Policy on feedback meetings2/4/198550FR4916
Notice: Withdraws 136 NDAs and ANDAs3/4/200570FR10651

General Procedures and Policies for OTC Drug Products: OTC/Prescription Dual Marketing

Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Public hearing4/27/200065FR24704
Advance Notice of Proposed Rulemaking9/1/200570FR52050