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

FDA Archive-It webpage:

Search for Federal Register documents:

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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