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

Topical Antibiotic Drug Products: Allergy Warning

Proposed Rule Date FR Citation
Proposed Rule 2/14/1996 61FR5918
Final Rule Date FR Citation
Final Rule 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 8/18/1989 54FR34188
Proposed Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate 5/11/1990 55FR19868
Proposed Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE 6/8/1990 55FR23450
   Correction 6/21/1990 55FR25392
Final Rule Date FR Citation
Final Rule: Classifies bacitracin- polymyxin B sulfate aerosol as GRASE combination 3/15/1990 55FR9721
Final Rule: Revises GRASE concentrations of bacitracin zinc- polymyxin B sulfate 10/3/1990 55FR40379
Final Rule: Classifies bacitracin zinc, polymyxin B sulfate, and neomycin sulfate with suitable anesthetic as GRASE 12/5/1990 55FR50171

Topical Antibiotic Drug Products: Exemption from Batch Certification

Proposed Rule Date FR Citation
Proposed Rule: Exempts monograph products 7/22/1985 50FR29702
Final Rule Date FR Citation
Final Rule 7/15/1986 51FR25523
   Correction 8/27/1986 51FR30478
   Correction 9/24/1986 51FR33897