FDA iron packaging requirement compliance may be delayed until July 1999, agency states.
Executive Summary
FDA IRON PACKAGING REQUIREMENTS: COMPLIANCE MAY BE DELAYED for two years if a firm "maintains appropriate stability data that support the expiration dating period used on the smallest version of the previously accepted product package," the agency states in its guidance for industry on "Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron" released June 26.