[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: 21CFR640.17]

[Page 89]
 
                        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 B--Red Blood Cells
 
Sec. 640.17  Modifications for specific products.

    Red Blood Cells Frozen: A cryophylactic substance may be added to 
the Red Blood Cells for extended manufacturers' storage at -65 deg. C or 
colder, provided the manufacturer submits data considered by the 
Director, Center for Biologics Evaluation and Research, as adequately 
demonstrating through in vivo cell survival and other appropriate tests 
that the addition of the substance, the materials used and the 
processing methods results in a final product that meets the required 
standards of safety, purity, and potency for Red Blood Cells, and that 
the frozen product will maintain those properties for the prescribed 
dating period. Section 640.11 (a) and (b) do not apply while a 
cryophylactic substance is present.

[38 FR 32089, Nov. 20, 1973, as amended at 41 FR 18292, May 3, 1976; 49 
FR 23834, June 8, 1984; 50 FR 4139, Jan. 29, 1985; 55 FR 11013, Mar. 26, 
1990; 63 FR 16685, Apr. 6, 1998]