[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.5]

[Page 98-99]
 
                        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 
 
                          Subpart A_Whole Blood
 
Sec. 640.5  Testing the blood.

    All laboratory tests shall be made on a specimen of blood taken from 
the donor at the time of collecting the unit of blood, and these tests 
shall include the following:
    (a) Serological test for syphilis. Whole Blood shall be negative to 
a serological test for syphilis.
    (b) Determination of blood group. Each container of Whole Blood 
shall be classified as to ABO blood group. At least two blood group 
tests shall be made and the unit shall not be issued until grouping 
tests by different methods or with different lots of antiserums are in 
agreement. Only those Anti-A and Anti-B Blood Grouping Reagents licensed 
under, or that otherwise meet the requirements of, the regulations of 
this subchapter shall be used, and the technique used shall be that for 
which the serum is specifically designed to be effective.
    (c) Determination of the Rh factors. Each container of Whole Blood 
shall be classified as to Rh type on the basis of tests done on the 
sample. The label shall indicate the extent of typing and the results of 
all tests performed. If the test, using Anti-D Blood Grouping Reagent, 
is positive, the container may be labeled ``Rh Positive.'' If the test 
is negative, the results shall be confirmed by further testing which 
shall include tests for the ``weak D (formerly D\u\).'' Blood may be 
labeled ``Rh Negative'' if

[[Page 99]]

further testing is negative. Units testing positive after additional 
more specific testing shall be labeled as ``Rh Positive.'' Only Anti-Rh 
Blood Grouping Reagents licensed under, or that otherwise meet the 
requirements of, this subchapter shall be used, and the technique used 
shall be that for which the reagent is specifically designed to be 
effective.
    (d) Sterility test. Whole Blood intended for transfusion shall not 
be tested for sterility by a method that entails entering the final 
container before the blood is used for transfusion.
    (e) Inspection. Whole Blood shall be inspected visually during 
storage and immediately prior to issue. If the color or physical 
appearance is abnormal or there is any indication or suspicion of 
microbial contamination the unit of Whole Blood shall not be issued for 
transfusion.
    (f) Test for communicable disease agents. Whole Blood shall be 
tested for evidence of infection due to communicable disease agents as 
required under Sec. 610.40 of this chapter.

[38 FR 32089, Nov. 20, 1973, as amended at 50 FR 4138, Jan. 29, 1985; 53 
FR 117, Jan. 5, 1988; 53 FR 12764, Apr. 19, 1988; 64 FR 45372, Aug. 19, 
1999; 66 FR 1836, Jan. 10, 2001; 66 FR 31165, June 11, 2001; 66 FR 
40889, Aug. 6, 2001]