U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron Guidance for Industry June 1997

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.