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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Smoking Deterrent Drug Products

Final Monographs (21 CFR 310.544):
Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent

OTC Smoking Deterrent Drug Products found on this page:

 
Smoking Deterrent Drug Products: Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 1/5/1982 47FR490
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 7/3/1985 50FR27552
    Extension of Comment Period [PDF] 7/17/1986 51FR25899
Final Rule Date FR Citation
Final Rule: No GRASE active ingredients [PDF] 6/1/1993 58FR31236
 
Smoking Deterrent 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 [PDF] 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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