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  7. Rulemaking History for OTC Acne Drug Products
  1. Status of OTC Rulemakings

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 Rulemaking Date FR Citation
 Advance Notice of Proposed Rulemaking  3/23/1982 47FR12430
     Correction  4/23/1982 47FR17575
Proposed Rule Date FR Citation
 Tentative Final Monograph  1/15/1985 50FR2172
Final Rule Date FR Citation
 Final Monograph  8/16/1991 56FR41008

Acne Drug Products: Benzoyl Peroxide

Advance Notice Of Proposed Rulemaking Date FR Citation
 Advance Notice of Proposed Rulemaking  3/23/1982 47FR12430
     Correction  4/23/1982 47FR17575
Proposed Rule Date FR Citation
 Tentative Final Monograph  1/15/1985 50FR2172
Proposed Rule: Reclassifies benzoyl peroxide from GRASE to Category III 8/7/1991 56FR37622
    Correction  10/8/1991 56FR50754
Proposed Rule: Additional labeling 2/17/1995 60FR9554
    Extension of Comment Period  5/19/1995 60FR26853
Final Rule Date FR Citation
Final Monograph 3/4/2010 75FR9767

Acne Drug Products: Nonmonograph Ingredients

Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph 5/16/1990 55FR20434
    Correction  6/7/1990 55FR23235
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph 11/7/1990 55FR46914
    Correction  12/3/1990 55FR49973
    Technical Amendment: Corrects an ingredient name 1/30/1992 57FR3526

Acne Drug Products: Time and Extent Application

Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: triclosan 12/5/2005 70FR72447