Inspections, Compliance, Enforcement, and Criminal Investigations
CPG Sec. 253.100- Use of Units of *Plasma and Fresh Frozen Plasma* Which Have Been Thawed
As prescribed by 21 CFR *606.122(m)(3),* the product *labeling* states that *frozen plasma* products should be used within six hours after thawing. However, some blood banks have been extending this time for as much as 26 days and using the plasma as a blood volume expander for transfusion.
The Blood Products Advisory Committee has made a recommendation to the *Center for Biologics Evaluation and Research (CBER)* that *Fresh Frozen Plasma* should be allowed for transfusion within 24 hours after thawing. The *CBER* is planning to change the regulation to allow for the transfusion of the *thawed Fresh Frozen* Plasma within 24 hours.
Until such time that the regulation is changed, *frozen plasma products* should be transfused within six hours of thawing. If not transfused within the six hours, the thawed plasma may be relabeled and used as Recovered Human Plasma for further manufacturing.
Failure to transfuse the product within the six hours will continue to be a deviation from 21 CFR *606.122(m)(3).* However, this deviation alone will not be considered to be of the significance which would warrant a recommendation for regulatory action.
*Material between asterisks is new or revised.*