[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: 21CFR640.2]

[Page 84-85]
 
                        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 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) Final container. The original blood container shall be the final 
container and shall not be entered prior to issue for any purpose except 
for blood collection. Such 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 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 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.
    (d) Issue prior to determination of test results. Notwithstanding 
the provisions of Sec. 610.1 of this chapter, blood may be issued by the 
manufacturer on the request of a physician, hospital, or other medical 
facility before results of all tests prescribed in Sec. 640.5, the test 
for hepatitis B surface antigen prescribed in Sec. 610.40(a) of this 
chapter, and a test for antibody to Human Immunodeficiency Virus (HIV) 
prescribed in Sec. 610.45(a) of this chapter have been completed, where 
such issue is essential to allow time for transportation to ensure 
arrival of the blood by the time it is needed for transfusion: Provided, 
That (1) the blood is shipped directly to such physician or medical 
facility, (2) the records of the manufacturer contain a full explanation 
of the need for such issue, and (3) the label on each

[[Page 85]]

container of such blood bears the information required by 
Sec. 606.121(h) of this chapter.

(Information collection requirements approved by the Office of 
Management and Budget under number 0910-0227)

[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]