Drugs
-
Rulemaking History for OTC Topical Antimicrobial Drug Products
|
Final Monograph (21 CFR part 333): |
OTC Topical Antimicrobial Drug Products found on this page:
- Alcohol
- Diaper Rash
- First Aid Antiseptic
- Healthcare Antiseptic
- Nonmonograph Ingredients
- Hexachlorophene
- Tribromsalan
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 5/21/1982 | 47FR22324 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 9/7/1982 | 47FR39406 |
| Correction [PDF] | 12/7/1982 | 47FR54981 |
| Extension of Comment Period [PDF] | 12/28/1982 | 47FR57738 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule [PDF] | 6/20/1990 | 55FR25246 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 9/13/1974 | 39FR33103 |
| Extension of Comment Period [PDF] | 10/17/1974 | 39FR37066 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 1/6/1978 | 43FR1210 |
| Extension of Comment Period [PDF] | 2/3/1978 | 43FR4637 |
| Reopening of Administrative Record [PDF] | 3/9/1979 | 44FR13041 |
| Reopening of Administrative Record: Category II & III active ingredients [PDF] | 10/26/1979 | 44FR61609 |
| Reopening of Administrative Record [PDF] | 3/21/1980 | 45FR18398 |
| Proposed Rule: Establishes first aid separate from healthcare antiseptics [PDF] | 7/22/1991 | 56FR33644 |
| Correction [PDF] | 1/9/1992 | 57FR858 |
| Call for Data: Miscellaneous products [PDF] | 12/31/2003 | 68FR75585 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 9/13/1974 | 39FR33103 |
| Extension of Comment Period [PDF] | 10/17/1974 | 39FR37066 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 1/6/1978 | 43FR1210 |
| Extension of Comment Period [PDF] | 2/3/1978 | 43FR4637 |
| Reopening of Administrative Record [PDF] | 3/9/1979 | 44FR13041 |
| Reopening of Administrative Record [PDF] | 10/26/1979 | 44FR61609 |
| Proposed Rule: Establishes healthcare separate from first aid antiseptics [PDF] | 6/17/1994 | 59FR31402 |
| Extension of Comment Period [PDF] | 11/15/1994 | 59FR58799 |
| Reopening of Administrative Record [PDF] | 5/29/2003 | 68FR32003 |
| Call for Data: Miscellaneous products [PDF] | 12/31/2003 | 68FR75585 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 8/25/1992 | 57FR38568 |
| Correction [PDF] | 9/8/1992 | 57FR40944 |
| Technical Amendment: Correct an ingredient name [PDF] | 10/1/1992 | 57FR45295 |
| Correction [PDF] | 11/9/1992 | 57FR53300 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 4/22/1998 | 63FR19799 |
| Proposed Rule: 60+ Drug Categories [PDF] | 6/19/2008 | 73FR34895 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule [PDF] | 1/7/1972 | 37FR219 |
| Request for Data: Hexachlorophene + 7 other ingredients [PDF] | 1/7/1972 | 37FR235 |
| Correction:1/7/1972 Request for Data [PDF] | 1/26/1972 | 37FR1182 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 9/27/1972 | 37FR20160 |
| Technical Amendment: Aerosol content determination [PDF] | 11/4/1972 | 37FR23537 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Prohibits certain halogenated salicylanilides [PDF] | 9/13/1974 | 39FR33102 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 10/30/1975 | 40FR50527 |
-
-
