Emergency use of oseltamivir beyond expiration dating

Relabeling not required; guidance issued by Agency.

FDA has indicated that the lots of oseltamivir (Tamiflu—Roche) now authorized by the Agency for use beyond their expiration dates are not required to be relabeled with information about the use of the products beyond their expiration dates. Additional guidance from FDA on authorization of use for 26 lots of expired oseltamivir and storage requirements for the drug are available here. Pharmacists may need to check with their state board of pharmacy if they have specific expiration dating requirements.

In response to a request from CDC, FDA granted oseltamivir an Emergency Use Authorization for treating or preventing 2009 H1N1 influenza. Additional information on dosing of oseltamivir as an oral suspension is available here.

CDC has also issued a fact sheet on oseltamivir that can be distributed to patients and parents. 

Web links

• FDA. Stockpiled antivirals at or nearing expiration

• FDA. Emergency Use Authorization for the Shelf Life Extension Program

• FDA. Emergency Use Authorization of Relenza (zanamivir) 

• CDC. Emergency Use Authorization of Tamiflu (oseltamivir)

• CDC. Oseltamivir fact sheet for patients and parents 

Related resources on pharmacist.com

• News article. Updated influenza antiviral drug recommendations provided by CDC, FDA 

Joe Sheffer (jsheffer@aphanet.org)
Posted October 14, 2009
Updated November 2, 2009