Rulemaking History for OTC Acne Drug Products

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Rulemaking History for OTC Topical Antimicrobial Drug Products
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Final Monograph (21 CFR part 333):
Topical Antimicrobial Drug Products for Over-the-Counter Human Use

OTC Topical Antimicrobial Drug Products found on this page:

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**Topical Antimicrobial Drug Products: Alcohol Original Indications**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	5/21/1982	47FR2234

**Topical Antimicrobial Drug Products: Diaper Rash**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	9/7/1982	47FR39406
Correction	12/7/1982	47FR54981
Extension of Comment Period	12/28/1982	47FR57738
Proposed Rule	Date	FR Citation
Proposed Rule	6/20/1990	55FR25246

**Topical Antimicrobial Drug Products: First Aid Antiseptic**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	9/13/1974	39FR33103
Extension of Comment Period	10/17/1974	39FR37066
Proposed Rule	Date	FR Citation
Tentative Final Monograph	1/6/1978	43FR1210
Extension of Comment Period	2/3/1978	43FR4637
Reopening of Administrative Record	3/9/1979	44FR13041
Reopening of Administrative Record: Category II & III active ingredients	10/26/1979	44FR61609
Reopening of Administrative Record	3/21/1980	45FR18398
Proposed Rule: Establishes first aid separate from healthcare antiseptics	7/22/1991	56FR33644
Correction	1/9/1992	57FR858
Call for Data: Miscellaneous products	12/31/2003	68FR75585

**Topical Antimicrobial Drug Products: Healthcare Antiseptic**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	9/13/1974	39FR33103
Extension of Comment Period	10/17/1974	39FR37066
Proposed Rule	Date	FR Citation
Tentative Final Monograph	1/6/1978	43FR1210
Extension of Comment Period	2/3/1978	43FR4637
Reopening of Administrative Record	3/9/1979	44FR13041
Reopening of Administrative Record	10/26/1979	44FR61609
Proposed Rule: Establishes healthcare separate from first aid antiseptics	6/17/1994	59FR31402
Extension of Comment Period	11/15/1994	59FR58799
Reopening of Administrative Record	5/29/2003	68FR32003
Call for Data: Miscellaneous products	12/31/2003	68FR75585

**Topical Antimicrobial Drug Products: Nonmonograph Ingredients**
Proposed Rule	Date	FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	8/25/1992	57FR38568
Correction	9/8/1992	57FR40944
Technical Amendment: Correct an ingredient name	10/1/1992	57FR45295
Correction	11/9/1992	57FR53300
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	4/22/1998	63FR19799
Proposed Rule: 60+ Drug Categories	6/19/2008	73FR34895

**Topical Antimicrobial Drug Products: Hexachlorophene**
Proposed Rule	Date	FR Citation
Proposed Rule	1/7/1972	37FR219
Request for Data: Hexachlorophene + 7 other ingredients	1/7/1972	37FR235
Correction:1/7/1972 Request for Data	1/26/1972	37FR1182
Final Rule	Date	FR Citation
Final Rule	9/27/1972	37FR20160
Technical Amendment: Aerosol content determination	11/4/1972	37FR23537

**Topical Antimicrobial Drug Products: Tribromsalan**
Proposed Rule	Date	FR Citation
Proposed Rule: Prohibits certain halogenated salicylanilides	9/13/1974	39FR33102
Final Rule	Date	FR Citation
Final Rule	10/30/1975	40FR50527

Date created: December 28, 2006;Last updated: June 23, 2008