Drugs

Rulemaking History for OTC Acne Drug Products

Final Monograph (21 CFR part 333 subpart D)
Topical Anti-Microbial Drug Products for Over-the-Counter Human Use

OTC Acne Drug Products found on this page:

Acne Drug Products: Original Active Ingredients & Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
 Advance Notice of Proposed Rulemaking 3/23/198247FR12430
     Correction 4/23/198247FR17575
Proposed RuleDateFR Citation
 Tentative Final Monograph 1/15/198550FR2172
Final RuleDateFR Citation
 Final Monograph 8/16/199156FR41008

Acne Drug Products: Benzoyl Peroxide

Advance Notice Of Proposed RulemakingDateFR Citation
 Advance Notice of Proposed Rulemaking 3/23/198247FR12430
     Correction 4/23/198247FR17575
Proposed RuleDateFR Citation
 Tentative Final Monograph 1/15/198550FR2172
Proposed Rule: Reclassifies benzoyl peroxide from GRASE to Category III8/7/199156FR37622
    Correction 10/8/199156FR50754
Proposed Rule: Additional labeling2/17/199560FR9554
    Extension of Comment Period 5/19/199560FR26853
Final RuleDateFR Citation
Final Monograph3/4/201075FR9767

Acne Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
    Correction 6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction 12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526

Acne Drug Products: Time and Extent Application

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: triclosan12/5/200570FR72447

 

Page Last Updated: 03/09/2017
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