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U.S. Department of Health and Human Services

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Rulemaking History for OTC Topical Antimicrobial Drug Products

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:


Topical Antimicrobial Drug Products: Alcohol Original Indications
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 5/21/1982 47FR22324

Topical Antimicrobial Drug Products: Diaper Rash
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

Topical Antimicrobial Drug Products: First Aid Antiseptic
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

Topical Antimicrobial Drug Products: Healthcare Antiseptic
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

Topical Antimicrobial Drug Products: Nonmonograph Ingredients
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

Topical Antimicrobial Drug Products: Hexachlorophene
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

Topical Antimicrobial Drug Products: Tribromsalan
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