The use of the plateletpheresis procedure to obtain a product for a specific recipient may be at variance with Sec. Sec. 640.21(c) and 640.22(c): Provided, That: (a) A licensed physician has determined that the recipient must be transfused with the platelets from a specific donor, and (b) the plateletpheresis procedure is performed under the supervision of a qualified licensed physician who is aware of the health status of the donor and the physician has certified in writing that the donor's health permits plateletpheresis. [40 FR 53544, Nov. 18, 1975]