(a) The use of plateletpheresis and leukapheresis procedures to obtain a product for a specific recipient may be at variance with the additional standards for specific products prescribed in this part provided that:
(1) A physician has determined that the recipient must be transfused with the leukocytes or platelets from a specific donor, and
(2) the procedure is performed under the supervision of a responsible physician who is aware of the health status of the donor, and the physician has determined and documented that the donor's health permits plateletpheresis or leukapheresis.
(b) Plasmapheresis of donors who do not meet the donor requirements of §§ 630.10 , 630.15 , 640.64 and 640.65 of this chapter for the collection of plasma containing rare antibodies shall be permitted only with the prior approval of the Director, Center for Biologics Evaluation and Research.