Rulemaking History for OTC Nailbiting and Thumbsucking Drug Products

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

Nailbiting and Thumbsucking Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking10/17/198045FR69122
Proposed RuleDateFR Citation
Tentative Final Monograph9/3/198247FR39096
Final RuleDateFR Citation
Final Monograph: No GRASE active ingredients9/2/199358FR46749

Nailbiting and Thumbsucking Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526
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Page Last Updated: 07/21/2017
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