[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: 21CFR640.71]

[Page 107]
 
                        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 G_Source Plasma
 
Sec. 640.71  Manufacturing responsibility.

    (a) All steps in the manufacturing of Source Plasma, including donor 
examination, blood collection, plasmapheresis, laboratory testing, 
labeling, storage, and issuing shall be performed by personnel of the 
establishment licensed to manufacture Source Plasma, except that the 
following tests may be performed by personnel of an establishment 
licensed for blood and blood derivatives under section 351(a) of the 
Public Health Service Act, or by a clinical laboratory that meets the 
standards of the Clinical Laboratories Improvement Amendments of 1988 
(CLIA) (42 U.S.C. 263a): Provided, The establishment or clinical 
laboratory is qualified to perform the assigned test(s).
    (1) The test for hepatitis B surface antigen.
    (2) The total plasma or serum protein and the quantitative test for 
plasma or serum proteins or for immunoglobulins.
    (3) The serologic test for syphilis.
    (4) A test for antibody to HIV.
    (b) Such testing shall not be considered divided manufacturing, 
which requires two biologics licenses for Source Plasma: Provided, That
    (1) The results of such tests are maintained by the licensed 
manufacturer of the Source Plasma whereby such results may be reviewed 
by a licensed physician as required in Sec. 640.65(b)(2) of this 
chapter and by an authorized representative of the Food and Drug 
Administration.
    (2) The Source Plasma manufacturer has obtained a written agreement 
that the testing laboratory will permit authorized representatives of 
the Food and Drug Administration to inspect its testing procedures and 
facilities during reasonable business hours.
    (3) The testing laboratory will participate in any proficiency 
testing programs undertaken by the Center for Biologics Evaluation and 
Research, Food and Drug Administration.

[41 FR 10770, Mar. 12, 1976, as amended at 49 FR 23834, June 8, 1984; 50 
FR 4140, Jan. 29, 1985; 53 FR 117, Jan. 5, 1988; 55 FR 11013, Mar. 26, 
1990; 64 FR 45374, Aug. 19, 1999; 64 FR 56453, Oct. 20, 1999; 66 FR 
1837, Jan. 10, 2001]