Rulemaking History for OTC Nailbiting and Thumbsucking 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 Nailbiting and Thumbsucking Drug Products
View by Date

Final Monograph (21 CFR 310.536):
Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent

Original Active Ingredients and Labeling
Nonmonograph Ingredients

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

**Nailbiting and Thumbsucking Drug Products: Original Active Ingredients and Labeling**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	10/17/1980	45FR69122
Correction	12/23/1980	45FR84836
Proposed Rule	Date	FR Citation
Tentative Final Monograph	9/3/1982	47FR39096
Correction	11/19/1982	47FR52200
Final Rule	Date	FR Citation
Final Monograph: No GRASE active ingredients	9/2/1993	58FR46749

**Nailbiting and Thumbsucking 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