Sodium phosphate drugs
This article was originally published in The Tan Sheet
Executive Summary
Rectal products containing sodium phosphate/sodium biphosphate would be required to bear sodium content and warning statements under a proposed rule published by FDA in the March 24 Federal Register. The proposal would apply the same requirements to rectal sodium phosphate drugs that now apply to other OTCs containing sodium. The action responds to concerns that individuals with certain medical conditions are at risk of an electrolyte imbalance when using such products. Comments are requested by June 22...
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