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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for General Procedures and Policies for OTC Drug Products
  1. Historical 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 Rule Date FR Citation
Notice of Availability: Draft Guidance 10/15/2007 72FR58316
        Guidance 10/15/2007  
Final Rule Date FR Citation
Notice of Availability: Final Guidance 7/14/2009 74FR34023
        Guidance 7/14/2009  

General Procedures and Policies for OTC Drug Products: Drug Review Procedures

Proposed Rule Date FR Citation
Proposed Rule: Review Procedures [PDF] 1/5/1972 37FR85
Final Rule Date FR Citation
Final Rule: Review Procedures 5/11/1972 37FR9464
        Correction 5/20/1972 37FR10358
Technical Amendment: Extend comment period for proposed rules to 90 days 10/11/1977 42FR54800

General Procedures and Policies for OTC Drug Products: Category III Active Ingredients

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking: Category III active ingredients become nonmonograph in final rule 10/26/1979 44FR61608
Proposed Rule Date FR Citation
Proposed Rule: Continued marketing of Category III active ingredients until final rule 10/21/1975 40FR49097
Proposed Rule: Category III active ingredients become nonmonograph in final rule 5/13/1980 45FR31422
Final Rule Date FR Citation
Final Rule: Continued marketing of Category III active ingredients until final rule 4/12/1977 42FR19137
Final Rule: Category III active ingredients become nonmonograph in final rule 9/29/1981 46FR47730

General Procedures and Policies for OTC Drug Products: Administrative Record

Proposed Rule Date FR Citation
Proposed Rule: Content and closing of administrative record 6/4/1974 39FR19878
Final Rule Date FR Citation
Final Rule: Content and closing of administrative record 11/8/1974 39FR39556

General Procedures and Policies for OTC Drug Products: Miscellaneous Policies

Final Rule Date FR Citation
Notice: Guideline available for OTC combination drug products 11/28/1978 43FR55466
Notice: Miscellaneous policies (including feedback policy) 9/29/1981 46FR47740
Notice: Economic impact analysis available 2/8/1983 48FR5806
Notice: Policy on feedback letters 4/1/1983 48FR14050
Notice: Policy on feedback meetings 2/4/1985 50FR4916
Notice: Withdraws 136 NDAs and ANDAs 3/4/2005 70FR10651

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

Advance Notice Of Proposed Rulemaking Date FR Citation
Notice: Public hearing 4/27/2000 65FR24704
Advance Notice of Proposed Rulemaking 9/1/2005 70FR52050

 

 

 
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