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.

Storage of Tamiflu (oseltamivir phosphate)

Tamiflu should be stored at controlled room temperature.  The United States Pharmacopeia (USP) defines controlled room temperature as a temperature that is maintained by thermostat and is between 20 and 25˚C (68 to 77˚ F).

Under the Emergency Use Authorization (EUA) for Tamiflu, the storage requirements for Tamiflu held in public health authority stockpiles may be waived for a maximum of 90 days (consecutive or non-consecutive) from the date of shipment to the public health authority.  This waiver is limited in that Tamiflu may be stored with temperature excursions in excess of 40°C (104˚F) for a total cumulative period of 14 days (consecutive or non-consecutive) within the 90-day period.  Other temperature excursions that are outside of the labeled temperature storage conditions are permitted within the 90-day period provided they do not exceed 40˚C (104˚ F).

Tamiflu Lots Whose Expiration Date Has Been Extended

Four lots (batches) of Tamiflu for Oral Suspension were tested in the federal government’s Shelf Life Extension Program (SLEP)¹.  FDA has determined that the data from scientific testing supported the extension of the expiration dates for these four lots of Tamiflu.  

The following table lists the lot numbers of Tamiflu Oral Suspension that have passed SLEP testing along with their original expiration dates and extended expiration dates:

Tamiflu for Oral Suspension

The U.S. Department of Health and Human Services continues to evaluate options for antiviral drugs that are approaching, or past, the labeled expiration date.

¹ Certain antiviral medications that are at or nearing their expiration date may be tested under the federal government’s Shelf-Life Extension Program (SLEP).  Under SLEP, FDA conducts scientific testing to see if specific lots of TAMIFLU can be used beyond the expiration dates originally printed on the label by the manufacturer.  If the product passes testing, FDA determines that the shelf life of the product can be extended beyond the expiration dates originally printed on the label.