Additional standards for human blood and blood products, source plasma (human); amendment of storage temperature requirements: Food and Drug Administration, Final rule

The Food and Drug Administration (FDA) is amending the storage temperature requirements for Source Plasma ((Human) intended for manufacture into injectable products. This change permits an inadvertent exposure of the product to an episode of storage temperature fluctuation between -20 degrees and -5 degrees C for no more than 72 hours without requiring relabeling of the frozen product from "Source Plasma (Human)" to "Source Plasma (Human) Salvaged." Data submitted to the agency demonstrate the satisfactory recovery of clotting factor concentrates from the plasma despite the temporary elevation of storage temperature.