U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Smoking Deterrent Drug Products
  1. Historical 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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 1/5/1982 47FR490
Proposed Rule Date FR Citation
Tentative Final Monograph 7/3/1985 50FR27552
    Extension of Comment Period 7/17/1986 51FR25899
Final Rule Date FR Citation
Final Rule: No GRASE active ingredients 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 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

Back to Top

 
Back to Top