FDA Finalizes Guidance on Extending Stockpiled Doxycycline Expiration Dates
The US Food and Drug Administration (FDA) on Wednesday finalized guidance on extending the expiration dates of the antibiotic doxycycline for state-level emergency response stockpiles.FDA first issued a draft version of the guidance in April 2017 in response to requests from state emergency response stakeholders who were looking for ways to extend the shelf life of doxycycline beyond the labeled expiration date to treat inhalation anthrax or for post-exposure prophylaxis against anthrax.
FDA says the final guidance has been updated to clarify some of the language present in the draft version, but does not feature any changes in policy from the earlier document.
Specifically, the guidance provides recommendations on the testing necessary to extend the expiration dates and details the process of requesting an extension for specified lots of doxycycline.
Unlike federally stockpiled drugs, which are eligible for testing by FDA through the Department of Defense (DoD) administered Federal Shelf-Life Extension Program (SLEP), drugs stockpiled for use as medical countermeasures by non-federal stakeholders can have their expiration dates extended under section 564A(b) of the Food, Drug, and Cosmetic Act.
Within the guidance, FDA lays out two testing protocols for extending the expiration dates of doxycycline based on whether the drugs have been stored according to labeled storage conditions and are less than six years beyond their labeled expiration date or whether the drugs have not been stored according to labeled storage conditions or are more than six years beyond their labeled expiration dates.
Lots of doxycycline that are tested and confirmed to be stable are eligible for a two-year expiration date extension.
In addition to the testing protocols detailed in the guidance, FDA says it may impose additional testing, periodic testing or retesting, storage, record keeping, labeling and distribution requirements on lots of doxycycline that receive expiration date extensions.
FDA also notes that the guidance applies to both doxycycline monohydrate and doxycycline hyclate in 50mg and 100mg tablets and capsules and does not apply to doxycycline that is commercially available or stored for any purpose other than emergency use.
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