Rulemaking History for OTC Boil Treatment Drug Products
Final Monograph (21 CFR 310.531):
Drug products containing active ingredients offered over-the-counter for the treatment of boils
OTC Boil Treatment Drug Products found on this page:
Boil Treatment Drug Products:Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] |
6/29/1982 |
47FR28306 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] |
1/26/1988 |
53FR2198 |
| 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: Correct an ingredient name [PDF] | 1/30/1992 | 57FR3526 |
| Final Monograph [PDF] |
11/15/1993 |
58FR60332 |
Boil Treatment Drug Products: Nonmonograph Ingredients
| 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 |