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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC First Aid Antibiotic Drug Products

Final Monograph (21 CFR part 333 subpart A):  
Topical Antimicrobial Drug Products for Over-the-Counter Human Use: First Aid Antibiotic Drug Products 

OTC Topical Antibiotic Drug Products found on this page:


Topical Antibiotic Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
 Advance Notice of Proposed Rulemaking [PDF] 4/1/1977 42FR17642
    Correction [PDF] 4/29/1977 42FR21816
    Reopening of Administrative Record [PDF] 3/21/1980 45FR18400
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 7/9/1982 47FR29986
    Correction [PDF] 1/9/1992 57FR858
Proposed Rule: Divides monograph into multiple subparts; proposes first aid antiseptic part [PDF] 7/22/1991 56FR33644
Final Rule Date FR Citation
Final Monograph [PDF] 12/11/1987 52FR47312
    Technical Amendment [PDF] 5/25/1988 53FR18837
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 4/22/1998 63FR19799

Topical Antibiotic Drug Products: Allergy Warning
Proposed Rule Date FR Citation
Proposed Rule [PDF] 2/14/1996 61FR5918
Final Rule Date FR Citation
Final Rule [PDF] 11/15/1996 61FR58471

Topical Antibiotic Drug Products: Bacitracin Combinations
Proposed Rule Date FR Citation
Proposed Rule: Classifies bacitracin-polymyxin B sulfate aerosol with suitable anesthetic as GRASE combination [PDF] 8/18/1989 54FR34188
Proposed Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate [PDF] 5/11/1990 55FR19868
Proposed Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE [PDF] 6/8/1990 55FR23450
    Correction [PDF] 6/21/1990 55FR25392
Final Rule Date FR Citation
Final Rule: Classifies bacitracin- polymyxin B sulfate aerosol as GRASE combination [PDF] 3/15/1990 55FR9721
Final Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate [PDF] 10/3/1990 55FR40379
Final Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE [PDF] 12/5/1990 55FR50171

Topical Antibiotic Drug Products: Exemption from Batch Certification
Proposed Rule Date FR Citation
Proposed Rule: Exempts monograph products [PDF] 7/22/1985 50FR29702
Final Rule Date FR Citation
Final Rule [PDF] 7/15/1986 51FR25523
    Correction [PDF] 8/27/1986 51FR30478
    Correction [PDF] 9/24/1986 51FR33897
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