Zdrowie i gospodarka · 09/07/1997

Guidance for Industry on Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron.'' The guidance document provides information to manufacturers of iron-containing drug products who are affected by a final rule that requires label warning statements and unit-dose packaging for solid oral drug products that contain 30 milligrams (mg) or more of iron per dosage unit. The guidance document describes the circumstances under which the agency does not intend to object, for a limited period of time, to modified expiration dating by drug manufacturers and packagers who are required to package their products into unit-dose containers under the final rule.