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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking10/19/197944FR60316
Proposed RuleDateFR Citation
Proposed Rule1/15/198550FR2184
Final RuleDateFR Citation
Final Rule: No GRASE active ingredients8/17/198853FR31270

Page Last Updated: 02/24/2017
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