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  4. How Drugs are Developed and Approved
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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Stomach Acidifier Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Stomach Acidifier Drug Products

Final Monograph (21 CFR 310.540):
Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers 

Stomach Acidifier Drug Products

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 10/19/1979 44FR60316
    Correction 8/15/1980 45FR54354
Proposed Rule Date FR Citation
Proposed Rule 1/15/1985 50FR2184
Final Rule Date FR Citation
Final Rule: No GRASE active ingredients 8/17/1988 53FR31270
 
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