General Procedures and Policies for OTC Drug Products found on this page:
Proposed Rule Date FR CitationNotice of Availability: Draft Guidance 10/15/2007 72FR58316 Guidance 10/15/2007 Final Rule Date FR CitationNotice of Availability: Final Guidance 7/14/2009 74FR34023 Guidance 7/14/2009
Proposed Rule Date FR CitationProposed Rule: Review Procedures [PDF] 1/5/1972 37FR85 Final Rule Date FR CitationFinal 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
Advance Notice Of Proposed Rulemaking Date FR CitationAdvance Notice of Proposed Rulemaking: Category III active ingredients become nonmonograph in final rule 10/26/1979 44FR61608 Proposed Rule Date FR CitationProposed 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 CitationFinal 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
Proposed Rule Date FR CitationProposed Rule: Content and closing of administrative record 6/4/1974 39FR19878 Final Rule Date FR CitationFinal Rule: Content and closing of administrative record 11/8/1974 39FR39556
Final Rule Date FR CitationNotice: 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
Advance Notice Of Proposed Rulemaking Date FR CitationNotice: Public hearing 4/27/2000 65FR24704 Advance Notice of Proposed Rulemaking 9/1/2005 70FR52050
Content current as of:
03/02/2017
