Executive Summary

IRON-CONTAINING PRODUCTS WILL REQUIRE WARNINGS AND UNIT-DOSE PACKAGING under a final rule published by FDA in the Jan. 15 Federal Register. The rule specifies that all solid oral dosage forms of iron-containing drugs and dietary supplements must bear a warning concerning pediatric poisoning. In addition, products containing 30 mg of iron or more per dose must be sold in unit-dose packaging. The agency proposed the warning and packaging requirements Oct. 6, 1994 ("The Tan Sheet" Oct. 10, 1994, p. 3).