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  7. Rulemaking History for OTC First Aid Antibiotic Drug Products
  1. Status of OTC Rulemakings

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 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