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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 Poison Treatment Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Poison Treatment Drug Products

Pending Final Monograph (21 CFR part 337): 
Emetic Drug Products for Over-the-Counter Human Use

Pending Final Monograph (21 CFR part 357 subpart A): 
Miscellaneous Internal Drug Products for Over-the-Counter Human Use: Treatment of Acute Toxic Ingestion
OTC Poison Treatment Drug Products found on this page:

Poison Treatment Drug Products: Emetic

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking: Ipecac syrup3/21/197540FR12902
Proposed RuleDateFR Citation
Tentative Final Monograph9/5/197843FR39544
    Correction11/28/197843FR55417

Poison Treatment 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

Poison Treatment Drug Products: Acute Toxic Ingestion

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking: Ipecac syrup and activated charcoal1/5/198247FR444
Proposed RuleDateFR Citation
Tentative Final Monograph1/15/198550FR2244
    Correction2/15/198550FR6359
    Correction3/6/198550FR9040
Notice: Advisory Committee Meeting, Ipecac Syrup5/6/200368FR24004
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