FDA 含铁固体口服制剂药品有效期与稳定性试验指南（1997年7月终版，FDA-1997-D-0489）

Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron

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美国 FDA 发布终版指南，说明受 1997 年 1 月 15 日联邦公报（62 FR 2218）最终规则影响的含铁固体口服药品生产商与包装商如何满足稳定性与有效期要求。该规则要求每剂量单位含铁 30 mg 及以上的固体口服药品加贴标签警示声明并采用单剂量包装。文件编号 FDA-1997-D-0489，由 CDER 发布，可随时按 21 CFR 10.115(g)(5) 提交意见。

正文

GUIDANCE DOCUMENT

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

Final

Docket Number:

FDA-1997-D-0489

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

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-1997-D-0489.