Stockpiled Antivirals at or Nearing Expiration

During
this public health emergency, the FDA has issued Emergency Use
Authorizations that expand access to medical products that may become
necessary.

Two antiviral treatments covered by Emergency Use Authorizations,
Tamiflu (oseltamavir) and Relenza (zanamivir), may already be included
in many emergency stockpiles.

All companies, U.S. states and localities, and other organizations
with Tamiflu and Relenza that are approaching, or past, the labeled
expiration date, are urged to consider keeping it while the U.S.
Department of Health and Human Services evaluates options, including
those that may allow for their use if needed during this 2009 H1N1 flu
virus outbreak.

If the stockpiling entity decides to retain expired or
soon-to-expire Tamiflu and Relenza, it should be maintained and
monitored under the product’s labeled storage conditions.

These organizations are also urged to contact the FDA’s Emergency
Operations Center with information on how much Tamiflu and Relenza in
their stockpiles is at or approaching expiration.

This information should be reported to:

FDA’s Emergency Operations Center
301-443-1240.

This statement is not directed to individual patients who already
have these two products in their homes. Individuals with these products
should continue to follow the directions from their doctor, pharmacist
or other health care professional.