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FDA invokes GMP authority to propose unit-dose packaging for iron-containing supplements.

This article was originally published in The Tan Sheet

Executive Summary

FDA INVOKES GMP AUTHORITY FOR IRON SUPPLEMENT UNIT-DOSE PACKAGING proposal in a "supplemental" proposed rule published in the Feb. 16 Federal Register. The notice provides a legal basis for an October 1994 proposed rule that requires child-resistant unit-dose packaging on all products (drugs and dietary supplements) that contain 30 mg or more iron per dosage unit. The supplemental rule, FDA explained, "set[s] forth [the agency's] legal authority" for the proposed rule after the passage of the Dietary Supplement Health & Education Act.
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