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

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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 Rulemaking4/1/197742FR17642
   Correction4/29/197742FR21816
   Reopening of Administrative Record3/21/198045FR18400
Proposed RuleDateFR Citation
Tentative Final Monograph7/9/198247FR29986
   Correction1/9/199257FR858
Proposed Rule: Divides monograph into multiple subparts; proposes first aid antiseptic part7/22/199156FR33644
Final RuleDateFR Citation
Final Monograph12/11/198752FR47312
   Technical Amendment5/25/198853FR18837
Final Rule: Classifies category II and III ingredients without data as nonmonograph4/22/199863FR19799

Topical Antibiotic Drug Products: Allergy Warning

Proposed RuleDateFR Citation
Proposed Rule2/14/199661FR5918
Final RuleDateFR Citation
Final Rule11/15/199661FR58471

Topical Antibiotic Drug Products: Bacitracin Combinations

Proposed RuleDateFR Citation
Proposed Rule: Classifies bacitracin-polymyxin B sulfate aerosol with suitable anesthetic as GRASE combination8/18/198954FR34188
Proposed Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate5/11/199055FR19868
Proposed Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE6/8/199055FR23450
   Correction6/21/199055FR25392
Final RuleDateFR Citation
Final Rule: Classifies bacitracin- polymyxin B sulfate aerosol as GRASE combination3/15/199055FR9721
Final Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate10/3/199055FR40379
Final Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE12/5/199055FR50171

Topical Antibiotic Drug Products: Exemption from Batch Certification

Proposed RuleDateFR Citation
Proposed Rule: Exempts monograph products7/22/198550FR29702
Final RuleDateFR Citation
Final Rule7/15/198651FR25523
   Correction8/27/198651FR30478
   Correction9/24/198651FR33897

 

Page Last Updated: 12/02/2016
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