Drugs
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Rulemaking History for OTC Acne Drug Products
Final Monograph (21 CFR part 333 subpart D): |
OTC Acne Drug Products found on this page:
- Original Active Ingredients & Labeling
- Benzoyl Peroxide
- Nonmonograph Ingredients
- Time and Extent Application
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 3/23/1982 | 47FR12430 |
| Correction [PDF] | 4/23/1982 | 47FR17575 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 1/15/1985 | 50FR2172 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 8/16/1991 | 56FR41008 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 3/23/1982 | 47FR12430 |
| Correction [PDF] | 4/23/1982 | 47FR17575 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 1/15/1985 | 50FR2172 |
| Proposed Rule: Reclassifies benzoyl peroxide from GRASE to Category III [PDF] | 8/7/1991 | 56FR37622 |
| Correction [PDF] | 10/8/1991 | 56FR50754 |
| Proposed Rule: Additional labeling [PDF] | 2/17/1995 | 60FR9554 |
| Extension of Comment Period [PDF] | 5/19/1995 | 60FR26853 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF and HTML] | 3/4/2010 | 75FR9767 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 5/16/1990 | 55FR20434 |
| Correction [PDF] | 6/7/1990 | 55FR23235 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 11/7/1990 | 55FR46914 |
| Correction [PDF] | 12/3/1990 | 55FR49973 |
| Technical Amendment: Corrects an ingredient name [PDF] | 1/30/1992 | 57FR3526 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Request for Data: triclosan [PDF] | 12/5/2005 | 70FR72447 |
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