Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles Guidance for Government Public Health and Emergency Response Stakeholders April 2019
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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:
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 .