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U.S. Department of Health and Human Services

Drugs

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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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 10/17/1980 45FR69122
    Correction [PDF] 12/23/1980 45FR84836
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 9/3/1982 47FR39096
    Correction [PDF] 11/19/1982 47FR52200
Final Rule Date FR Citation
Final Monograph: No GRASE active ingredients [PDF] 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 [PDF] 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 [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Corrects an ingredient name [PDF] 1/30/1992 57FR3526
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