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U.S. Department of Health and Human Services

Drugs

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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 [PDF]3/23/198247FR12430
     Correction [PDF]4/23/198247FR17575
Proposed RuleDateFR Citation
 Tentative Final Monograph [PDF]1/15/198550FR2172
Final RuleDateFR Citation
 Final Monograph [PDF]8/16/199156FR41008

Acne Drug Products: Benzoyl Peroxide
Advance Notice Of Proposed RulemakingDateFR Citation
 Advance Notice of Proposed Rulemaking [PDF]3/23/198247FR12430
     Correction [PDF]4/23/198247FR17575
Proposed RuleDateFR Citation
 Tentative Final Monograph [PDF]1/15/198550FR2172
Proposed Rule: Reclassifies benzoyl peroxide from GRASE to Category III [PDF]8/7/199156FR37622
    Correction [PDF]10/8/199156FR50754
Proposed Rule: Additional labeling [PDF]2/17/199560FR9554
    Extension of Comment Period [PDF]5/19/199560FR26853
Final RuleDateFR Citation
Final Monograph [PDF and HTML]3/4/201075FR9767

Acne Drug Products: Nonmonograph Ingredients
Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name [PDF]1/30/199257FR3526

Acne Drug Products: Time and Extent Application
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: triclosan [PDF]12/5/200570FR72447