[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: 21CFR640.17]

[Page 95-96]
 
                        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 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

[[Page 96]]

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]