Expiration - Thawed Plasma
After thawing frozen plasma, how long can it be stored before infusion?
Joint Commission standards refer to the Food and Drug Administration (FDA) regulations for blood product labeling requirements. Effective July 2, 2012 and current as of 2016, the FDA regulations will allow the infusion of thawed fresh frozen plasma for up to 24 hours after thawing. The need for a variance from the FDA to transfuse plasma beyond the original six-hour limit will no longer be required. The scheduled regulation change was published in the Federal Register, Vol. 77, No. 1, Tuesday January 3, 2012/Rules and Regulations 7. When frozen plasma is thawed, the product is still considered to be fresh frozen plasma for up to the 24 hours. After 24 hours, the product should be labeled as thawed plasma. The license number should be struck, because this is no longer a licensed product according to the FDA. For more information on product modifications, an excellent resource is found on the AABB website,
Last updated on April 11, 2016
Chapter: Quality System Assessment for Nonwaived Testing QSA