[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR606.110]

[Page 50]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 606_CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD 
COMPONENTS--Table of Contents
 
                Subpart F_Production and Process Controls
 
Sec. 606.110  Plateletpheresis, leukapheresis, and plasmapheresis.

    (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 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 or leukapheresis.
    (b) Plasmapheresis of donors who do not meet the donor requirements 
of Sec. Sec. 640.63, 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.

[40 FR 53532, Nov. 18, 1975, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11013, Mar. 26, 1990]