New FDA Draft Guidance: Extended Expiration Dating for Doxycycline

The Food and Drug Administration (FDA) recently published new draft guidance, titled: “Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles; Draft Guidance for Government Public Health and Emergency Response Stakeholders.” The draft guidance is also published in the Federal Register and electronic and written comments are currently being accepted until June 26, 2017.

Additional background:

  • This draft guidance will enable state and local stakeholders to conduct their own testing (e.g., through a contract laboratory) of their lots of stockpiled oral doxycycline for anthrax preparedness using the protocol outlined in the guidance and submit their findings to FDA, which may authorize extensions based on acceptable results under section 564A(b) of the Food, Drug & Cosmetic Act (i.e., the expiry dating extension authority provided by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) for approved medical countermeasures).
  • FDA will make authorized lot extensions publicly available for any other stakeholder that is properly storing the same lot(s).
  • Issuance of this guidance does not mean that the federal Shelf-Life Extension Program (SLEP) has been extended to states. The Department of Defense-managed SLEP program remains limited to federal stockpiles of critical medical materiel.

FDA is hoping to convene a stakeholder webinar soon to discuss the details of this guidance (details to be shared on this blog once available). For additional questions on this guidance, contact Brooke Courtney at brooke.courtney@fda.hhs.gov.

About Raymond Puerini

Raymond Puerini, MPH, is a Senior Program Analyst on the Environmental Health, Pandemic Preparedness, and Catastrophic Response team at NACCHO. His work includes sharing best practices for the distribution and dispensing of medical countermeasures and developing policy and guidance to support strategic national stockpile responses. Twitter: @Are_You_Ray_Dy

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