Drugs
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Rulemaking History for OTC Skin Protectant Drug Products
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Final Monograph (21 CFR part 347): |
OTC Skin Protectant Drug Products found on this page:
- Original Active Ingredients and Labeling
- Astringent
- Diaper Rash
- Fever Blister and Cold Sore
- Nonnonograph Ingredients
- Poison Ivy, Oak, Sumac and Insect Bites
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 8/4/1978 | 43FR34628 |
| Correction [PDF] | 9/19/1978 | 43FR42018 |
| Reopening of Administrative Record [PDF] | 3/21/1980 | 45FR18402 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 2/15/1983 | 48FR6820 |
| Correction [PDF] | 4/12/1983 | 48FR15655 |
| Reopening of Administrative Record: To include "hard fat" [PDF] | 12/19/1991 | 56FR65873 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 6/4/2003 | 68FR33362 |
| Technical Amendment: Corrects indications [PDF] | 12/9/2003 | 68FR68509 |
| Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF] | 8/19/2004 | 69FR51362 |
| Technical Amendment: Lip protectant labeling [PDF] | 2/1/2008 | 73FR6014 |
| Availability of Guidance (Labeling) [PDF] | 8/4/2008 | 73FR45227 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 9/7/1982 | 47FR39436 |
| Correction [PDF] | 10/15/1982 | 47FR46117 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule [PDF] | 4/3/1989 | 54FR13490 |
| Correction [PDF] | 4/27/1989 | 54FR18197 |
| Proposed Rule: Revises labeling to be consistent with 6/4/2003 final monograph [PDF] | 6/13/2003 | 68FR35346 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 10/21/1993 | 58FR54458 |
| Final Rule: Revises "Hamamelis water" to "witch hazel" [PDF] | 6/3/1994 | 59FR28767 |
| Direct Final Rule: Revises labeling to be consistent with 6/4/2003 final monograph [PDF] | 6/13/2003 | 68FR35290 |
| Confirmation of effective date [PDF] | 10/9/2003 | 68FR58273 |
| Correction [PDF] | 1/22/2004 | 69FR3005 |
| Technical Amendment: Astringents producing aluminum acetate | 3/6/2009 | 74FR9759 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Reopening of Administrative Record [PDF] | 9/7/1982 | 47FR39436 |
| Correction [PDF] | 10/15/1982 | 47FR46117 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule [PDF] | 6/20/1990 | 55FR25204 |
| Extension of Comment Period: Vitamins A and D [PDF] | 12/18/1990 | 55FR51926 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 6/4/2003 | 68FR33362 |
| Technical Amendment: Corrects indications [PDF] | 12/9/2003 | 68FR68509 |
| Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF] | 8/19/2004 | 69FR51362 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Reopening of Administrative Record [PDF] | 9/7/1982 | 47FR39436 |
| Correction [PDF] | 10/15/1982 | 47FR46117 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule [PDF] | 1/31/1990 | 55FR3362 |
| Correction [PDF] | 3/27/1990 | 55FR11291 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 6/4/2003 | 68FR33362 |
| Technical Amendment: Corrects indications [PDF] | 12/9/2003 | 68FR68509 |
| Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF] | 8/19/2004 | 69FR51362 |
| 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 |
| 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 |
| Proposed Rule: 60+ Drug Categories [PDF] | 6/19/2008 | 73FR34895 |
| 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 |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 5/10/1993 | 58FR27636 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Reopening of Administrative Record [PDF] | 9/7/1982 | 47FR39436 |
| Correction [PDF] | 10/15/1982 | 47FR46117 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule [PDF] |
10/3/1989 |
55FR40808 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 6/4/2003 | 68FR33362 |
| Technical Amendment: Corrects indications [PDF] | 12/9/2003 | 68FR68509 |
| Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545 [PDF] | 8/19/2004 | 69FR51362 |
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