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The FDA uses two terms for plasma that may serve as the starting material for the manufacture of derivatives: plasma and source plasma. Plasma is “the fluid portion of one unit of human blood intended for intravenous use” [36]. This plasma, which is a by‐product of whole blood collected by blood supply organizations or hospitals, is sold to commercial companies in the plasma fractionation industry, who in turn manufacture the plasma derivatives and sell them in the pharmaceutical market. The blood banks’ sale of their plasma to the commercial fractionator (manufacturer) may, but usually does not, involve an agreement to provide some of the manufactured derivatives back to the blood bank.

The amount of plasma obtained from whole blood is not adequate to meet the needs for raw material to produce plasma derivatives. Although plasma collection data are not readily available, an estimated 44 million liters is probably collected annually by plasmapheresis in about 650 collection centers in North America [35]. This is called source plasma, which is “the fluid portion of human blood collected by plasmapheresis and intended as the source material for further manufacturing use” [36]. Automated instruments are usually used to obtain 650–1000 mL of plasma up to twice weekly from healthy adult donors. An individual can donate up to about 100 L of plasma annually in the United States, if the plasma protein levels and other laboratory tests and physical findings remain normal.