[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: 21CFR640.74]

[Page 108]
 
                        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. 640.74  Modification of Source Plasma.

    (a) Upon approval by the Director, Center for Biologics Evaluation 
and Research, Food and Drug Administration, of a supplement to the 
biologics license application for Source Plasma, a manufacturer may 
prepare Source Plasma as a liquid product for a licensed blood 
derivative manufacturer who has indicated a need for a liquid product.
    (b) Source Plasma Liquid shall meet all standards of the frozen 
Source Plasma except:
    (1) Source Plasma Liquid shall be stored in nonleachable containers 
so that the containers and their components will not interact with the 
plasma contents under conditions of storage and use so as to alter the 
safety, quality, purity, or potency of the plasma and shall provide 
adequate protection against external factors that may cause 
deterioration or contamination.
    (2) Source Plasma Liquid shall be shipped, stored and labeled for 
storage at a temperature of 10 [deg]C or colder. An exception to the 
shipping or storage temperature shall be approved by the Director, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, based upon his receipt of substantial evidence to 
support another temperature. Such evidence may be submitted by either 
the licensed manufacturer of the Source Plasma Liquid or the 
manufacturer of the final blood derivative product who has requested the 
Source Plasma Liquid.
    (3) The label for the Source Plasma Liquid shall be easily 
distinguished from that of the frozen product. Color coding shall not be 
used for this purpose.
    (4) The label affixed to each container of Source Plasma Liquid 
shall contain, in addition to the information required by Sec. 
640.70(a) but excluding Sec. 640.70(a)(3), the name of the manufacturer 
of the final blood derivative product for whom it was prepared.
    (5) Source Plasma Liquid shall be inspected immediately prior to 
issuance. If the color or physical appearance is abnormal, or there is 
any indication or suspicion of microbial contamination, the unit of 
Source Plasma Liquid shall not be issued.

[38 FR 32089, Nov. 20, 1973. Redesignated and amended at 41 FR 10770, 
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 56454, Oct. 20, 1999]

[[Page 109]]