Rulemaking History for OTC Topical Antimicrobial Drug Products
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Date	Federal Register Citation	Description
1/7/1972	37FR219	Proposed Rule: hexachlorophene
1/7/1972	37FR235	Request for Data: hexachlorophene + 7 other ingredients
1/26/1972	37FR1182	Correction: 1/7/1972 Request for Data
9/27/1972	37FR20160	Final Rule: Hexachlorophene
11/4/1972	37FR23537	Technical Amendment: Aerosol content determination (hexachlorophene)
9/13/1974	39FR33102	Proposed Rule: Prohibits certain halogenated salicylanides (e.g., tribromsalan)
9/13/1974	39FR33103	Advance Notice of Proposed Rulemaking
10/17/1974	39FR37066	Extension of Comment Period: 9/13/1974 Advance Notice of Proposed Rulemaking
10/30/1975	40FR50527	Final Rule: Prohibits certain halogenated salicylanides (e.g., tribromsalan)
1/6/1978	43FR1210	Tentative Final Monograph
2/3/1978	43FR4637	Extension of Comment Period: Tentative Final Monograph
3/9/1979	44FR13041	Reopening of the Administrative Record: Tentative Final Monograph
10/26/1979	44FR61609	Reopening of the Administrative Record: Category II and III active ingredients (Tentative Final Monograph)
3/21/1980	45FR18398	Reopening of Administrative Record: First aid antiseptics
5/21/1982	47FR22321	Advance Notice of Proposed Rulemaking: Alcohol products
9/7/1982	47FR39406	Advance Notice of Proposed Rulemaking: Diaper rash
12/7/1982	47FR54981	Correction: 9/7/1982 Advance Notice of Proposed Rulemaking
12/28/1982	47FR57738	Extension of Comment Period: 9/7/1982 Advance Notice of Proposed Rulemaking
6/20/1990	55FR25246	Proposed Rule: Diaper rash
7/22/1991	56FR33644	Proposed Rule: Establishes first aid separate from healthcare antiseptics
1/9/1992	57FR858	Correction: 7/22/1991 Proposed Rule
6/17/1994	59FR31402	Proposed Rule: Establishes healthcare separate from first aid antiseptics
11/15/1994	59FR58799	Extension of Comment Period: 6/17/1994 Proposed Rule
4/22/1998	63FR19799	Final Rule: Classifies category II and III ingredients without data as nonmonograph
5/29/2003	68FR32003 [HTML]	Reopening of Administrative Record: Healthcare antiseptics (6/17/1994 Proposed Rule)
12/31/2003	68FR75585 [HTML]	Call for Data: Miscellaneous products
6/20/2008	73FR34895	Proposed Rule: 60+ Drug Categories

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Date updated: June 23, 2008

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