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
FDA Archive-It webpage:
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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 |