FDA发布延长战略储备中多西环素片剂和胶囊有效期的终版指南
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles
FDA发布终版一级指南，说明政府公共卫生与应急响应利益相关方可通过检测延长战略储备中多西环素片剂和胶囊的有效期。该指南2019年4月发布，文件编号2019-08349，由CDER发布，依据《联邦食品、药品和化妆品法》第564A(b)条。储备产品用于炭疽紧急事件中的暴露后预防或治疗。
GUIDANCE DOCUMENT
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles Guidance for Government Public Health and Emergency Response Stakeholders April 2019
Final Level 1 Guidance
- Docket Number:
- 2019-08349
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
A number of government public health and emergency response stakeholders2 maintain stockpiles of doxycycline3 tablets or capsules for post-exposure prophylaxis (PEP) or treatment of inhalational anthrax in the event of an anthrax emergency. States have asked FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality (i.e., purity and potency) beyond the manufacturer’s labeled expiration date so the replacement of stockpiled product could be deferred.4
This document provides guidance to government stakeholders on testing to extend the expiration date—under section 564A(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act5—of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency.
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: 2019-08349 .
来源：FDA Pharmaceutical Quality Documents · fda.gov