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
301-796-8240 or 1-866-300-4374.

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).

Authorization of Use for Certain Lots of Expired Tamiflu and Relenza

Eighteen lots of Tamiflu Capsules and three lots of Relenza Inhalation Powder have been authorized by FDA for use beyond their expiration dates.  FDA has authorized the use of these lots beyond their expiration dates under Emergency Use Authorizations (Tamiflu EUA and Relenza EUA) that specify certain conditions of use.  FDA’s decision to authorize the use of these lots beyond their expiration dates is supported by FDA’s approval of applications submitted by the manufacturers of Tamiflu and Relenza that extended the expiration dates of certain Tamiflu and Relenza products.

These lots are only authorized for use beyond their expiration dates under the EUAs during the period of time that the Secretary of the Department of Health and Human Services' (HHS’s) April 26, 2009 declaration of emergency justifying the EUAs remains in effect.  The declaration is set to expire on June 23, 2010, unless it is terminated earlier, but it could be extended by the Secretary of HHS if certain criteria are met. 

Entities holding any of the lots identified below may wish to consider retaining them following termination of the declaration of emergency in the event that their use may be authorized under an EUA in a future declared emergency.  If the entity decides to retain such lots of Tamiflu and/or Relenza, they should be maintained and monitored under the products' labeled storage conditions.
 

Tamiflu Capsules

Relenza Inhalation Powder

¹ Date of authorization – October 30, 2009

Authorization of Use for Certain Lots of Expired Tamiflu Tested in the Shelf Life Extension Program (SLEP)

Twenty-six lots of Tamiflu for Oral Suspension and one lot of Tamiflu Capsules have been tested in the federal government’s Shelf Life Extension Program (SLEP)². FDA has determined that the data from scientific testing and analysis support the use of these lots beyond their expiration dates. FDA has authorized the use of these lots beyond their expiration dates under an Emergency Use Authorization.

The following table lists the lots of Tamiflu for Oral Suspension and Tamiflu Capsules that have passed SLEP testing. The table also lists the original expiration dates of these lots and information about their use beyond their expiration dates until their "Date Supported by SLEP Testing." Please note, however, that these lots will only be authorized for use beyond their expiration dates under the Emergency Use Authorization (EUA) during the period of time that the Secretary of the Department of Health and Human Services’ (HHS’s) April 26, 2009 declaration of emergency justifying the EUA remains in effect. The declaration is set to expire on June 23, 2010, unless it is terminated earlier, but could be extended by the Secretary of HHS if certain criteria are met.

Entities holding any of the lots identified below may wish to consider retaining them following termination of the declaration of emergency in the event that their use may be authorized under an EUA in a future declared emergency.  If the entity decides to retain such lots of Tamiflu and/or Relenza, they should be maintained and monitored under the products' labeled storage conditions.
 

Tamiflu for Oral Suspension

Tamiflu Capsules

The U.S. Department of Health and Human Services continues to evaluate options for antiviral drugs that are approaching, or past, their expiration dates.  Please continue to access this webpage for new information.

² 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 and analysis to see if specific lots of TAMIFLU can be used beyond their expiration dates. If the product passes testing, FDA determines that the shelf life of the product can be extended beyond its expiration date.
³ Date of Authorization - July 14, 2009
⁴ Added on October 1, 2009 for use under July 14, 2009 authorization
⁵ Added on October 2, 2009 for use under July 14, 2009 authorization
⁶ Added on October 30, 2009 for use under July 14, 2009 authorization
⁷ Authorization only includes Tamiflu Capsules from lot number B1056 held in the Centers for Disease Control and Prevention’s Strategic National Stockpile.

Additional Information
Information for Healthcare Professionals - Authorization of Use of Expired Tamiflu for Oral Suspension