[Skip navigation] FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
 
Powered by Google
 

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

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


Date Federal Register Citation Description

3/6/1979

44FR12271 PDF document

Notice: Advisory review panel change

12/3/1982

47FR54646 PDF document

Advance Notice of Proposed Rulemaking

2/8/1983

48FR5761 PDF document

Correction: Advance Notice of Proposed Rulemaking

2/8/1983

48FR5762 PDF document

Extension of comment period

2/28/1983 48FR8261 PDF document Correction: Advance Notice of Proposed Rulemaking

7/30/1986

51FR27346 PDF document

Tentative Final Monograph

10/1/1986

51FR35003 PDF document

Extension of Comment Period: Tentative Final Monograph

11/25/1986

51FR42676 PDF document

Correction: Tentative Final Monograph

5/16/1990 55FR20434 PDF document Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
6/7/1990 55FR23235 PDF document Correction: 5/16/1900 Proposed Rule
11/7/1990 55FR46914 PDF document Final Rule: Classifies category II and III ingredients without data as nonmonograph
12/3/1990 55FR49973 PDF document Correction: 11/7/1990 Final Rule
1/30/1992 57FR3526 PDF document Technical Amendment: Corrects an ingredient name (11/7/1990 Final Rule)

12/4/1991

56FR63554 PDF document

Final Monograph

1/17/1992

57FR2136 PDF document

Correction: Final Monograph

4/5/1993

58FR17554 PDF document

Proposed Rule: Adds 0.6% micronized selenium sulfide as GRASE

1/28/1994

59FR4000 PDF document

Final Rule: Adds micronized selenium sulfide as GRASE

2/18/2004 69FR7652 PDF document Request for Data: Piroctone olamine (Time and Extent Application)
12/5/2005 69FR28932 PDF document Extension of Comment Period: Request for Data
12/5/2005 70FR72448 PDF document
[HTML]    
Request for Data: Climbazole (Time and Extent Application)

12/9/2005

70FR73178 PDF document
[HTML]    

Proposed Rule: Adds combination of coal tar and menthol as GRASE

3/6/2007 72FR9849 PDF document
[HTML]    
Final Rule: Adds combination of coal tar and menthol as GRASE

PDF document PDF requires the free Adobe Acrobat Reader

top arrow Back to Top     back arrow Back to Rulemaking Index

Date updated: May 9, 2007

horizonal rule