Rulemaking History for OTC Dandruff, Seborrheic, Dermatitis and Psoriasis Drug Products

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research

Rulemaking History for OTC Dandruff, Seborrheic, Dermatitis and Psoriasis Drug Products
View by Date

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:

Original Active Ingredients and Labeling
Time and Extent Applications
Coal Tar and Menthol
Selenium Sulfide
Nonmonograph Ingredients

Note: This page links to PDF files which require the free Adobe Acrobat Reader.

**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	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

**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

Date created: December 28, 2006; Last updated: May 4, 2007