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  7. Rulemaking History for OTC Smoking Deterrent Drug Products
  1. Status of OTC Rulemakings

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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking1/5/198247FR490
Proposed RuleDateFR Citation
Tentative Final Monograph7/3/198550FR27552
    Extension of Comment Period7/17/198651FR25899
Final RuleDateFR Citation
Final Rule: No GRASE active ingredients6/1/199358FR31236

Smoking Deterrent Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
    Correction6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526

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