FDA Publishes Guidance on Extending Expiration Dates of Doxycycline in Strategic Stockpiles

The Food and Drug Administration (FDA) has published its final guidance “Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic National Stockpiles: Guidance for Government Public Health and Emergency Response Stakeholders.” The document provides guidance to government stakeholders that maintain stockpiles of doxycycline tablets or capsules for post-exposure prophylaxis (PEP) or treatment of inhalation anthrax in the event of an anthrax emergency and finalizes the draft guidance issued in April 2017.

This guidance has been prepared in response to requests from states asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturer’s labeled expiration date so the replacement of stockpiled product could be deferred. The document provides guidance on testing to extend the expiration date—under the Federal Food, Drug, and Cosmetic Act (FD&C Act)—of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This applies to both doxycycline monohydrate and doxycycline hyclate tablets and capsules equivalent to 50 milligrams (mg) and 100 mg of doxycycline that are indicated for PEP or treatment of inhalational anthrax.

“Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic National Stockpiles” can be found on the FDA website: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/extending-expiration-dates-doxycycline-tablets-and-capsules-strategic-stockpiles

Additional information about MCM expiration dating extensions, including currently authorized doxycycline expiry dating extensions, can be found here.

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