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In Brief: Iron-containing drugs/supplements

This article was originally published in The Tan Sheet

Executive Summary

Iron-containing drugs/supplements: National Pharmaceutical Alliance, in April 28 citizen petition, asks FDA for a stay of action on implementation of the Jan. 15 final rule affecting iron-containing solid oral dosage form drugs and supplements, specifically the provisions applying to blister pack packaging. The rule, which goes into effect July 15, requires blister packs for products in capsule or tablet form that exceed 20 mg per dosage unit and requires a label warning about fatal poisoning in children. NPA wants the action stayed until Jan. 15, 1998, for three reasons: 1) it would allow for full compliance from industry, including any necessary reformulation or repackaging; 2) the stay would "allow for a certain amount of natural marketplace transition to conforming products"; and 3) the six-month extension is "necessary to prevent the public health risk associated with a temporary market shortage of these products." The petition was filed by the D.C. office of McKenna & Cuneo...





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