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
Advisory review panel change3/6/197944FR12271disclaimer icon
Advance Notice Of Proposed Rulemaking12/3/198247FR54646disclaimer icon
   Correction2/8/198348FR5761disclaimer icon
Extension of Comment Period2/8/198348FR5762disclaimer icon
   Correction2/28/198348FR8261disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph7/30/198651FR27346disclaimer icon
   Correction11/25/198651FR42676disclaimer icon
Extension of Comment Period10/1/198651FR35003disclaimer icon
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434disclaimer icon
   Correction6/7/199055FR23235disclaimer icon
Final RuleDateFR Citation
Final Rule Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914disclaimer icon
   Correction12/3/199055FR49973disclaimer icon
Technical Amendment: Correct an ingredient name1/30/199257FR3526disclaimer icon
Final Monograph12/4/199156FR63554disclaimer icon
   Correction1/17/199257FR2136disclaimer icon

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 sulfide4/5/199358FR17554disclaimer icon
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 nonmonograph5/16/199055FR20434disclaimer icon
   Correction6/7/199055FR23235disclaimer icon
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914disclaimer icon
   Correction12/3/199055FR49973disclaimer icon
   Technical Amendment: Corrects an ingredient name1/30/199257FR3526disclaimer icon

Back to Top

Page Last Updated: 02/09/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English