• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

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 Rulemaking Date FR Citation
Notice: Advisory review panel change [PDF] 3/6/1979 44FR12271
Advance Notice Of Proposed Rulemaking [PDF] 12/3/1982 47FR54646
    Correction [PDF] 2/8/1983 48FR5761
Extension of Comment Period [PDF] 2/8/1983 48FR5762
    Correction [PDF] 2/28/1983 48FR8261
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 7/30/1986 51FR27346
    Correction [PDF] 11/25/1986 51FR42676
Extension of Comment Period [PDF] 10/1/1986 51FR35003
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Correct an ingredient name [PDF] 1/30/1992 57FR3526
Final Monograph [PDF] 12/4/1991 56FR63554
    Correction [PDF] 1/17/1992 57FR2136

Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Time and Extent Applications
Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Piroctone olamine [PDF] 2/18/2004 69FR7652
    Extension of Comment Period [PDF] 5/19/2004 69FR28932
Request for Data: Climbazole [PDF] 12/5/2005 70FR72448
Time and Extent Applications Proposed Rule Sodium Shale Oil Sulfonate [PDF] 4/7/2009 74FR15741

Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Coal Tar and Menthol
Proposed Rule Date FR Citation
Proposed Rule: Adds combination [PDF] 12/9/2005 70FR73178
Final Rule Date FR Citation
Final Rule [PDF] 3/6/2007  72FR9849

Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Selenium Sulfide
Proposed Rule Date FR Citation
Proposed Rule: Adds 0.6% micronized selenium sulfide [PDF] 4/5/1993 58FR17554
Final Rule Date FR Citation
Final Rule [PDF] 1/28/1994 59FR4000

Dandruff, Seborrheic, Dermatitis, and Psoriasis Drug Products: Nonmonograph Ingredients
Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 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 [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Corrects an ingredient name [PDF] 1/30/1992 57FR3526