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  6. Status of OTC Rulemakings
  7. Rulemaking History for OTC Dandruff, Seborrheic, Dermatitis and Psoriasis Drug Products
  1. 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 RulemakingDateFR Citation
Advisory review panel change3/6/197944FR12271
Advance Notice Of Proposed Rulemaking12/3/198247FR54646
   Correction2/8/198348FR5761
Extension of Comment Period2/8/198348FR5762
   Correction2/28/198348FR8261
Proposed RuleDateFR Citation
Tentative Final Monograph7/30/198651FR27346
   Correction11/25/198651FR42676
Extension of Comment Period10/1/198651FR35003
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
   Correction6/7/199055FR23235
Final RuleDateFR Citation
Final Rule Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
   Correction12/3/199055FR49973
Technical Amendment: Correct an ingredient name1/30/199257FR3526
Final Monograph12/4/199156FR63554
   Correction1/17/199257FR2136

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

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Piroctone olamine2/18/200469FR7652
Extension of Comment Period5/19/200469FR28932
Request for Data: Climbazole12/5/200570FR72448
Time and Extent Applications Proposed Rule Sodium Shale Oil Sulfonate4/7/200974FR15741

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

Proposed RuleDateFR Citation
Proposed Rule: Adds combination12/9/200570FR73178
Final RuleDateFR Citation
Final Rule3/6/200772FR9849

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

Proposed RuleDateFR Citation
Proposed Rule: Adds 0.6% micronized selenium sulfide4/5/199358FR17554
Final RuleDateFR Citation
Final Rule1/28/199459FR4000

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

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
   Correction6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
   Correction12/3/199055FR49973
   Technical Amendment: Corrects an ingredient name1/30/199257FR3526

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