Drugs

Rulemaking History for Administrative Procedures for OTC Drug Products

FDA Archive-It webpage:

Rulemaking History for Administrative Procedures for OTC Drug Products 

Use the links below to search for Federal Register documents:

Administrative Procedures for OTC Drug Products found on this page:

Administrative Procedures for OTC Drug Products: Drug Review Procedures

 

Proposed RuleDateFR Citation
Proposed Rule: Review Procedures1/5/197237FR85
Final RuleDateFR Citation
Final Rule: Review Procedures5/11/197237FR9464
         -Correction 5/20/197237FR10358
Technical Amendment: Extend comment period for proposed rules to 90 days10/11/197742FR54800

Administrative Procedures 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

Administrative Procedures 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

Administrative Procedures 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

Administrative Procedures for OTC Drug Products: OTC/Prescription Dual Marketing

Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Public hearing4/27/200065FR24704
Advance Notice of Proposed Rulemaking 9/1/200570FR52050

 

 

 

Page Last Updated: 11/29/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English