FDA Guidance for Industry: Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron
Title:
FDA Guidance for Industry: Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/cder/guidance , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070276.pdf
Content:
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.