Unit-dose iron products real-time stability testing not required for two years -- FDA .
This article was originally published in The Tan Sheet
Executive Summary
IRON-CONTAINING PRODUCTS EXPIRATION DATING, STABILITY REQUIREMENTS two-year compliance period is allowed under a Center for Drug Evaluation & Research "Guidance for Industry" released in June. The guidance narrowly precedes the July 15 effective date for FDA's final rule requiring label warning statements and unit-dose packaging for all solid oral drug and dietary supplement products containing 30 mg or more of iron ("The Tan Sheet" Jan. 20, pp. 1-4).