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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Hypophosphatemia/Hyperphosphatemia Drug Products

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


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