PIC subject to iron unit-dose packaging requirement, FDA tells Schwarz Pharma.
This article was originally published in The Tan Sheet
Executive Summary
PIC SUBJECT TO IRON UNIT-DOSE PACKAGING REQUIREMENTS, FDA SAYS in a July 17 denial of a citizen petition by Schwarz Pharma requesting that polysaccharide-iron complex (PIC) be exempt from the final rule requiring unit-dose packaging for products containing 30 mg or more of iron per dosage unit. The company had asked FDA to first temporarily exclude the ingredient and, after a future submission of animal data comparing the toxicity of PIC to iron salts, make the exemption permanent ("The Tan Sheet" April 28, p. 7). The FDA final rule, in addition to mandating unit-dose packaging, calls for label warnings on iron-containing supplements in solid oral dosage form ("The Tan Sheet" Jan. 20, pp. 1-4).