Drugs

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 RulemakingDateFR Citation
 Advance Notice of Proposed Rulemaking [PDF]4/1/197742FR17642
    Correction [PDF]4/29/197742FR21816
    Reopening of Administrative Record [PDF]3/21/198045FR18400
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]7/9/198247FR29986
    Correction [PDF]1/9/199257FR858
Proposed Rule: Divides monograph into multiple subparts; proposes first aid antiseptic part [PDF]7/22/199156FR33644
Final RuleDateFR Citation
Final Monograph [PDF]12/11/198752FR47312
    Technical Amendment [PDF]5/25/198853FR18837
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]4/22/199863FR19799

Topical Antibiotic Drug Products: Allergy Warning
Proposed RuleDateFR Citation
Proposed Rule [PDF]2/14/199661FR5918
Final RuleDateFR Citation
Final Rule [PDF]11/15/199661FR58471

Topical Antibiotic Drug Products: Bacitracin Combinations
Proposed RuleDateFR Citation
Proposed Rule: Classifies bacitracin-polymyxin B sulfate aerosol with suitable anesthetic as GRASE combination [PDF]8/18/198954FR34188
Proposed Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate [PDF]5/11/199055FR19868
Proposed Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE [PDF]6/8/199055FR23450
    Correction [PDF]6/21/199055FR25392
Final RuleDateFR Citation
Final Rule: Classifies bacitracin- polymyxin B sulfate aerosol as GRASE combination [PDF]3/15/199055FR9721
Final Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate [PDF]10/3/199055FR40379
Final Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE [PDF]12/5/199055FR50171

Topical Antibiotic Drug Products: Exemption from Batch Certification
Proposed RuleDateFR Citation
Proposed Rule: Exempts monograph products [PDF]7/22/198550FR29702
Final RuleDateFR Citation
Final Rule [PDF]7/15/198651FR25523
    Correction [PDF]8/27/198651FR30478
    Correction [PDF]9/24/198651FR33897

 

Page Last Updated: 11/19/2014
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