Drugs
Rulemaking History for Administrative Procedures for OTC Drug Products
Administrative Procedures for OTC Drug Products found on this page:
Administrative Procedures 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 [PDF] | 5/11/1972 | 37FR9464 |
| -Correction [PDF] | 5/20/1972 | 37FR10358 |
| Technical Amendment: Extend comment period for proposed rules to 90 days [PDF] | 10/11/1977 | 42FR54800 |
Administrative Procedures 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 [PDF] | 10/26/1979 | 44FR61608 |
| Proposed Rule | Date | FR Citation |
|---|
| Proposed Rule: Continued marketing of Category III active ingredients until final rule [PDF] | 10/21/1975 | 40FR49097 |
| Proposed Rule: Category III active ingredients become nonmonograph in final rule [PDF] | 5/13/1980 | 45FR31422 |
| Final Rule | Date | FR Citation |
|---|
| Final Rule: Continued marketing of Category III active ingredients until final rule [PDF] | 4/12/1977 | 42FR19137 |
| Final Rule: Category III active ingredients become nonmonograph in final rule [PDF] | 9/29/1981 | 46FR47730 |
Administrative Procedures for OTC Drug Products: Administrative Record| Proposed Rule | Date | FR Citation |
|---|
| Proposed Rule: Content and closing of administrative record [PDF] | 6/4/1974 | 39FR19878 |
| Final Rule | Date | FR Citation |
|---|
| Final Rule: Content and closing of administrative record [PDF] | 11/8/1974 | 39FR39556 |
Administrative Procedures for OTC Drug Products: Miscellaneous Policies | Final Rule | Date | FR Citation |
|---|
| Notice: Guideline available for OTC combination drug products [PDF] | 11/28/1978 | 43FR55466 |
| Notice: Miscellaneous policies (including feedback policy) [PDF] | 9/29/1981 | 46FR47740 |
| Notice: Economic impact analysis available [PDF] | 2/8/1983 | 48FR5806 |
| Notice: Policy on feedback letters [PDF] | 4/1/1983 | 48FR14050 |
| Notice: Policy on feedback meetings [PDF] | 2/4/1985 | 50FR4916 |
| Notice: Withdraws 136 NDAs and ANDAs [PDF] | 3/4/2005 | 70FR10651 |
Administrative Procedures for OTC Drug Products: OTC/Prescription Dual Marketing | Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|
| Notice: Public hearing [PDF] | 4/27/2000 | 65FR24704 |
| Advance Notice of Proposed Rulemaking [PDF] | 9/1/2005 | 70FR52050 |
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