Rulemaking History for OTC Skin Bleaching Drug Products
Pending Final Monograph (21 CFR part 358 subpart A):
Miscellaneous External Drug Products for Over-the-Counter Human Use: Skin Bleaching Drug Products
Miscellaneous External Drug Products for Over-the-Counter Human Use: Skin Bleaching Drug Products
OTC Skin Bleaching Drug Products found on this page:
Skin Bleaching Drug Products : Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 11/3/1978 | 43FR51546 |
| Reopening of Administrative Record | 3/21/1980 | 45FR18404 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph: Classifies hydroquinone as only GRASE active ingredient | 9/3/1982 | 47FR39108 |
| Correction | 11/19/1982 | 47FR52200 |
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph | 5/16/1990 | 55FR20434 |
| Correction | 6/7/1990 | 55FR23235 |
| Proposed Rule: Reclassifies hydroquinone as nonmonograph; withdraws tentative final monograph | 8/29/2006 | 71FR51146 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph | 11/7/1990 | 55FR46914 |
| Correction | 12/3/1990 | 55FR49973 |
| Technical Amendment: Correct an ingredient name | 1/30/1992 | 57FR3526 |
Drug Products: Nonmonograph Ingredients
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph | 5/16/1990 | 55FR20434 |
| Correction | 6/7/1990 | 55FR23235 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph | 11/7/1990 | 55FR46914 |
| Correction | 12/3/1990 | 55FR49973 |
| Technical Amendment: Corrects an ingredient name | 1/30/1992 | 57FR3526 |