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Regulatory News | 24 April 2017 | By Michael Mezher
In response to questions from state health officials, the US Food and Drug Administration (FDA) on Monday issued draft guidance detailing how state emergency health response stakeholders can extend the shelf life of stockpiled doxycycline.
Around the country, emergency health response stakeholders, ranging from some state and local organizations to the Centers for Disease Control and Prevention (CDC), stockpile doxycycline for use as a medical countermeasure against an anthrax attack.
However, these stockpiles must be replenished from time to time when the stored drugs expire, unless the expiration date is extended by FDA.
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 if they meet the criteria established by FDA.
Now, FDA is putting forward its recommendations for non-federal stakeholders to follow in order to extend the expiration dates for stockpiled doxycycline, including how to identify a laboratory to conduct testing and the process for requesting an extension from the agency.
According to FDA, the recommendations will apply to 50mg and 100mg capsules and tablets of doxycycline monohydrate and doxycycline hyclate that are indicated for post-exposure prophylaxis or treatment of inhalation anthrax.
Tags: Doxycycline, Medical Countermeasures, MCM, Anthrax