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GUIDANCE DOCUMENT

Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles Guidance for Government Public Health and Emergency Response Stakeholders April 2019

Download the Final Guidance Document Read the Federal Register Notice
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.

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All written comments should be identified with this document's docket number: 2019-08349 .

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