[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.2]

[Page 91-92]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
--Table of Contents
 
                          Subpart A_Whole Blood
 
Sec. 640.2  General requirements.

    (a) Manufacturing responsibility. All manufacturing of Whole Blood, 
including donor examination, blood collection, laboratory tests, 
labeling, storage and issue, shall be done under the supervision and 
control of the same licensed establishment except that the Director, 
Center for Biologics Evaluation and Research, may approve arrangements, 
upon joint request of two or more licensed establishments, which he 
finds are of such a nature as to assure compliance otherwise with the 
provisions of this subchapter.
    (b) Blood container. The blood container shall not be entered prior 
to issue for any purpose except for blood collection or when the method 
of processing requires use of a different container. The container shall 
be uncolored and transparent to permit visual inspection of the contents 
and any closure shall be such as will maintain an hermetic seal and 
prevent contamination of the contents. The container material shall not 
interact with the contents under the customary conditions of storage and 
use, in such a manner as to have an adverse effect upon the safety, 
purity, or potency of the blood.
    (c) Reissue of blood. Blood that has been removed from storage 
controlled by a licensed establishment shall not be reissued by a 
licensed establishment unless the following conditions are observed:
    (1) The container has a tamper-proof seal when originally issued and 
this seal remains unbroken;
    (2) A segment is properly attached and has not been removed, except 
that blood lacking a properly attached segment may be reissued in an 
emergency provided it is accompanied by instructions for sampling and 
for use within 6

[[Page 92]]

hours after entering the container for sampling;
    (3) The blood has been stored continuously at 1 to 6 [deg]C and 
shipped between 1 and 10 [deg]C;
    (4) The blood is held for observation until a significant inspection 
consistent with the requirements of Sec. 640.5(e) can be made.

[38 FR 32089, Nov. 20, 1973, as amended at 41 FR 4015, Jan. 28, 1976; 42 
FR 59878, Nov. 22, 1977; 43 FR 34460, Aug. 4, 1978; 49 FR 15187, Apr. 
18, 1984; 49 FR 23834, June 8, 1984; 50 FR 4138, Jan. 29, 1985; 53 FR 
116, Jan. 5, 1988; 55 FR 11013, Mar. 26, 1990; 63 FR 16685, Apr. 6, 
1998; 64 FR 45371, Aug. 19, 1999; 66 FR 1836, Jan. 10, 2001; 66 FR 
31165, June 11, 2001; 66 FR 40889, Aug. 6, 2001; 67 FR 9587, Mar. 4, 
2002]