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  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 Nailbiting and Thumbsucking Drug Products
  1. Historical Status of OTC Rulemakings

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 10/17/1980 45FR69122
    Correction 12/23/1980 45FR84836
Proposed Rule Date FR Citation
Tentative Final Monograph 9/3/1982 47FR39096
    Correction 11/19/1982 47FR52200
Final Rule Date FR Citation
Final Monograph: No GRASE active ingredients 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 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
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