FDA seeks carbonyl iron toxicity data; permanent packaging exemption may be granted.
This article was originally published in The Tan Sheet
Executive Summary
CARBONYL IRON ANIMAL SAFETY DATA SOUGHT BY FDA in a final rule on iron-containing drugs and dietary supplements published in the Jan. 15 Federal Register . Under the rule, carbonyl iron is exempted from unit-dose packaging requirements for products containing 30 mg or more of iron only until July 15, 1998. However, "if during the temporary exemption period, FDA receives animal data that establish that carbonyl iron is significantly less toxic than at least one commonly used iron salt," a permanent exemption may be granted.
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