Rulemaking History for OTC Anorectal 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 Anorectal Drug Products
View by Date

Final Monograph (21 CFR part 346):
Anorectal Drug Products for Over-the-Counter Human Use

OTC Anorectal Drug Products found on this page:

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

**Anorectal Drug Products: Original Active Ingredients & Labeling**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	5/27/1980	45FR35576
Correction	7/22/1980	45FR48920
Correction	8/15/1980	45FR54354
Reopening of Administrative Record: Camphor-containing products	9/26/1980	45FR63876
Proposed Rule	Date	FR Citation
Tentative Final Monograph	8/15/1988	53FR30756
Final Rule	Date	FR Citation
Final Monograph	8/3/1990	55FR31776
Technical Amendment: Live yeast cell derivative (LYCD)	9/2/1993	58FR46746
Technical Amendment: USP name change ("Hamamelis water" to "witch hazel")	6/3/1994	59FR28766
Technical Amendment: Combination of hydrocortisone and pramoxine hydrochloride is nonmonograph	8/26/2003	68FR51167

**Anorectal Drug Products: Sodium Labeling**
Proposed Rule	Date	FR Citation
Proposed Rule: Sodium phosphate-containing products	3/24/2004	69FR13765
Final Rule	Date	FR Citation
Final Rule	11/29/2004	69FR69278

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