Issue Date: July 9, 1997
Issued by: Center for Drug Evaluation and Research
Topic(s): Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Final
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron: Guidance for Industry
This guidance describes how manufacturers and packagers affected by the final rule that published in the Federal Register (62 FR 2218) on January 15, 1997, requiring label warning statements and unit-dose packaging for solid oral drug products that contain 30 milligrams (mg) or more of iron per dosage unit, may meet stability and expiration dating requirements.
Download the Guidance Document
