[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: 21CFR640.94]

[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. 640.94  Labeling.

    In addition to the labeling requirements of Secs. 610.60, 610.61, 
and 610.62 of this chapter, the container and package labels shall 
contain the following information:
    (a) The osmotic equivalent in terms of plasma, and the sodium 
concentration in terms of a value or a range in milliequivalents per 
liter.
    (b) The cautionary statement placed in a prominent position on the 
label, ``Do Not Use if Turbid. Do Not Begin Administration More than 4 
Hours After the Container Has Been Entered.''

[42 FR 27583, May 31, 1977, as amended at 49 FR 2244, Jan. 19, 1984; 64 
FR 26286, May 14, 1999]

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