FDA Extends Expiration Dates of Certain Lots of State and Local Held Doxycycline

The Food and Drug Administration (FDA) has recently released a memo indicating that six lots of Doxycycline Hyclate 100-mg tablets manufactured by West-Ward Pharmaceuticals may be used beyond their labeled expiration dates assuming they were stored under the manufacturer’s labeled storage conditions. FDA is not requiring that these products be relabeled but stakeholders who dispense these medication during an actual public health emergency response should inform the receipts that FDA has determined that the product may be safely and effectively used beyond its labeled expiration date.

The FDA is not testing additional lots of doxycycline products outside of the Department of Defense / FDA Shelf-Life Extension Program or accepting requests from states and locals at this time for testing of additional lots of doxycycline or other products. However, medical countermeasures (MCMs) in state and local caches should continued to be stored according to manufacturer specified conditions until either further information is provided or the jurisdiction opts to properly dispose of the products.

For questions related to this memorandum, please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov.

To view the entire memo for additional details and to see which doxycycline lots are affected, click here.

To learn more about other previously released FDA statements on MCMs, click here.

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

One thought on “FDA Extends Expiration Dates of Certain Lots of State and Local Held Doxycycline

  1. Brooke Courtney
    June 16, 2016 at 9:28 am

    Thank you, Raymond, for posting this information! If helpful, additional information on FDA’s MCM emergency use authorities and activities can be found on FDA’s main MCM website: http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/default.htm.

    Also, partners might be interested in signing up for the FDA MCMi listserv for updates on FDA’s MCM activities (at the same website above) or through Twitter (@FDA_MCMi). Thanks!

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