[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: 21CFR640.93]

[Page 105]
 
                        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 I--Plasma Protein Fraction (Human)
 
Sec. 640.93  General requirements.

    (a) Preservative. The final product shall not contain a 
preservative.
    (b) Storage of bulk solution. After all processing steps have been 
completed, the sterile bulk solution shall be stored in a manner that 
will ensure the continued sterility of the product, and at a temperature 
that shall not exceed the recommended storage temperature of the final 
product prescribed in Sec. 610.53 of this chapter.