Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron To meet the requirements of the iron regulations, manufacturers and packagers must determine an appropriate expiration date for the drug products in unit-dose packages. Accelerated stability testing may be impractical because drug products containing iron, especially multivitamin products, often do not perform well under the artificially stressful conditions of accelerated studies. As a result, real-time stability testing may be the only method to determine an appropriate expiration date. However, the final iron regulations were published only six months before they were to take effect; therefore, there may be insufficient time for some manufacturers of solid oral drug products containing 30 mg or more of iron per dosage unit to perform real-time stability testing on their products. To minimize the burden faced by those manufacturers who have made good faith efforts to comply with