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U.S. Department of Health and Human Services


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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 [PDF] 10/19/1979 44FR60316
    Correction [PDF] 8/15/1980 45FR54354
Proposed Rule Date FR Citation
Proposed Rule [PDF] 1/15/1985 50FR2184
Final Rule Date FR Citation
Final Rule: No GRASE active ingredients [PDF] 8/17/1988 53FR31270