FDA 发布甘油二甘醇检测最终指南
Testing of Glycerin for Diethylene Glycol
FDA 发布甘油二甘醇检测最终指南（文件编号 FDA-2023-D-1573），提醒药品生产商、配制方、重包装商和供应商注意甘油及其他高风险组分被二甘醇或乙二醇污染的潜在公共健康风险。指南提到 FDA 持续收到相关报告，最近一次在 2023 年初，涉及消费者服用以受 DEG 或 EG 污染组分生产的液体制剂后发生致命中毒。该指南可在任何时间按 21 CFR 10.115(g)(5) 提交意见。
该最终指南提示关注甘油等高风险组分被二甘醇或乙二醇污染的风险，并说明可按 21 CFR 10.115(g)(5) 随时提交意见。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2023-D-1573
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance is intended to alert pharmaceutical manufacturers, compounders, repackers, and suppliers to the potential public health hazard of glycerin and other high-risk drug components contaminated with diethylene glycol (DEG) or ethylene glycol (EG). FDA has received and continues to receive (most recently in early 2023) reports about fatal poisonings of consumers who ingested drug products in a liquid dosage form (such as cough, allergy, analgesic, and antiemetic drug products) that were manufactured with DEG- or EG-contaminated components.
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-2023-D-1573 .
来源：FDA Pharmaceutical Quality Documents · fda.gov