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In this section: 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:

Adverse Event Reporting
Drug Review Procedures
Category II Active Ingredients
Administrative Record
Miscellaneous Policies
OTC/Prescription Dual Marketing

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Notice of Availability: Draft Guidance	10/15/2007	72FR58316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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