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Rulemaking History for OTC Acne Drug Products
View by Date

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:

Note: This page links to PDF files which require the free Adobe Acrobat Reader.


Acne Drug Products: Original Active Ingredients & Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 2/23/1982 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 2/23/1982 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

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

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Date created: December 28, 2006; Last updated: May 4, 2007

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