[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.64]

[Page 96]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                        Subpart G--Source Plasma
 
Sec. 640.64  Collection of blood for Source Plasma.

    (a) Supervision. All blood for the collection of Source Plasma shall 
be drawn from the donor by a qualified licensed physician or by persons 
under his supervision trained in the procedure.
    (b) Blood containers. Blood containers and donor sets shall be 
pyrogen-free, sterile and identified by lot number. The amount of 
anticoagulant required for the quantity of blood to be collected shall 
be in the blood container when it is sterilized.
    (c) The anticoagulant solution. The anticoagulant solution shall be 
sterile and pyrogen-free. One of the following formulas shall be used in 
the indicated volumes, except that a different formula may be used for 
plasma for manufacture into noninjectable products if prior written 
approval is obtained from the Director of the Center for Biologics 
Evaluation and Research at the time of licensing or in the form of a 
supplement to the biologics license application for Source Plasma.
    (1) Anticoagulant citrate dextrose solution (ACD).

Tri-sodium citrate (Na3C6H5O72H2O).
Citric acid (C6H8O7H2O)........  8.0 grams.
Dextrose (C6H12O6H2O)....................  24.5 grams.
Water for injection (U.S.P.) to make.....  1,000 milliliters.
Volume per 100 milliliters blood.........  15 milliliters.


    (2) Anticoagulant citrate phosphate dextrose solution (CPD).

Tri-sodium citrate (Na3C6H5O72H2O).
Citric acid (C6H8O7H2O)........  3.27 grams.
Dextrose (C6H12O6H2O)....................  25.5 grams.
Monobasic sodium phosphate (NaH2PO4H2O).
Water for injection (U.S.P.) to make.....  1,000 milliliters.
Volume per 100 milliliters blood.........  14 milliliters.


    (3) Anticoagulant sodium citrate solution.

Tri-sodium citrate (Na3C6H5O72H2O).
Water for injection (U.S.P.) to make.....  1,000 milliliters.
Volume per 100 milliliters of blood......  10 milliliters.


    (d) Donor identification. Each unit of blood and plasma shall be so 
marked or identified by number or other symbol so as to relate it 
directly to the donor.
    (e) Prevention of contamination of the blood and plasma. The skin of 
the donor at the site of phlebotomy shall be prepared thoroughly and 
carefully by a method that gives maximum assurance of a sterile 
container of blood. The blood shall be collected, the plasma separated, 
and the cells returned to the donor by aseptic methods in a sterile 
system which may be closed, or may be vented if the vent protects the 
blood cells and plasma against contamination.

[38 FR 32089, Nov. 20, 1973; 39 FR 13632, Apr. 16, 1974, as amended at 
41 FR 10768, Mar. 12, 1976; 49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 
29, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 63 FR 
16685, Apr. 6, 1998; 64 FR 56453, Oct. 20, 1999]