Section 490.770  Preparation of Blood Components

Preparation of red blood cells, frozen red blood cells, deglycerolized red blood cells, leukocyte poor red blood cells, washed red blood cells, liquid plasma, fresh frozen plasma, cryoprecipitated AHF, platelet concentrate, granulocyte concentrate, and any other preparation separated from single units of whole blood and intended for use as final products for transfusion shall follow preparation, storage, and expiration date requirements as specified by FDA (21 CFR 640)(1987).