Drugs

Rulemaking History for OTC Dandruff, Seborrheic, Dermatitis and Psoriasis Drug Products

Final Monograph (21 CFR part 358 subpart H):
Miscellaneous External Drug Products for Over-the-Counter Human Use: Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products

OTC Dandruff, Seborrheic, Dermatitis and Psoriasis Drug Products found on this page:

Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Advisory review panel change [PDF]3/6/197944FR12271
Advance Notice Of Proposed Rulemaking [PDF]12/3/198247FR54646
    Correction [PDF]2/8/198348FR5761
Extension of Comment Period [PDF]2/8/198348FR5762
    Correction [PDF]2/28/198348FR8261
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]7/30/198651FR27346
    Correction [PDF]11/25/198651FR42676
Extension of Comment Period [PDF]10/1/198651FR35003
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: Correct an ingredient name [PDF]1/30/199257FR3526
Final Monograph [PDF]12/4/199156FR63554
    Correction [PDF]1/17/199257FR2136

Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Time and Extent Applications

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Piroctone olamine [PDF]2/18/200469FR7652
    Extension of Comment Period [PDF]5/19/200469FR28932
Request for Data: Climbazole [PDF]12/5/200570FR72448
Time and Extent Applications Proposed Rule Sodium Shale Oil Sulfonate [PDF]4/7/200974FR15741

Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Coal Tar and Menthol

Proposed RuleDateFR Citation
Proposed Rule: Adds combination [PDF]12/9/200570FR73178
Final RuleDateFR Citation
Final Rule [PDF]3/6/2007 72FR9849

Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Selenium Sulfide

Proposed RuleDateFR Citation
Proposed Rule: Adds 0.6% micronized selenium sulfide [PDF]4/5/199358FR17554
Final RuleDateFR Citation
Final Rule [PDF]1/28/199459FR4000

Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/16/199055FR20434
    Correction6/7/199055FR23235
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

 

Page Last Updated: 05/04/2016
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