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Rulemaking History for OTC Hypophosphatemia/Hyperphosphatemia Drug Products
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Final Monographs (21 CFR 310.541 & 310.542):
Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphosphatemia/hyperphosphosphatemia

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Hypophosphatemia/Hyperphosphatemia Drug Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 12/9/1980 45FR81154
    Correction 1/9/1981 46FR2365
Proposed Rule Date FR Citation
Proposed Rule: No GRASE ingredients & adds professional labeling for antacids 1/15/1985 50FR2160
Final Rule Date FR Citation
Final Monograph: No GRASE ingredients & adds professional labeling for antacids 5/11/1990 55FR19852

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Date created: December 28, 2006; Last updated: May 4, 2007
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