Additional standards for human blood and blood products; source plasma (human)--Food and Drug Administration. Final...

The Food and Drug Administration [FDA] is amending the biologics regulations to make clear that an active plasmapheresis donor, who is to be immunized for the production of high-titer plasma, does not need to be reexamined before the first immunization injection if the same donor has previously received a physical examination for plasmapheresis in accordance with section 640.63(b)(1). This rule eliminates a burden on the individual plasmapheresis donor and the plasmapheresis center.