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  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Dandruff, Seborrheic, Dermatitis and Psoriasis Drug Products
  1. Historical Status of OTC Rulemakings

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
Advisory review panel change 3/6/1979 44FR12271
Advance Notice Of Proposed Rulemaking 12/3/1982 47FR54646
   Correction 2/8/1983 48FR5761
Extension of Comment Period 2/8/1983 48FR5762
   Correction 2/28/1983 48FR8261
Proposed Rule Date FR Citation
Tentative Final Monograph 7/30/1986 51FR27346
   Correction 11/25/1986 51FR42676
Extension of Comment Period 10/1/1986 51FR35003
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: Correct an ingredient name 1/30/1992 57FR3526
Final Monograph 12/4/1991 56FR63554
   Correction 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 2/18/2004 69FR7652
Extension of Comment Period 5/19/2004 69FR28932
Request for Data: Climbazole 12/5/2005 70FR72448
Time and Extent Applications Proposed Rule Sodium Shale Oil Sulfonate 4/7/2009 74FR15741

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

Proposed Rule Date FR Citation
Proposed Rule: Adds combination 12/9/2005 70FR73178
Final Rule Date FR Citation
Final Rule 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 4/5/1993 58FR17554
Final Rule Date FR Citation
Final Rule 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 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

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