[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: 21CFR640.84]

[Page 104]
 
                        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 H--Albumin (Human)
 
Sec. 640.84  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.'';
    (c) The need for additional fluids when 20 percent or 25 percent 
albumin is administered to a patient with marked dehydration;
    (d) The protein concentration, expressed as a 4 percent, 5 percent, 
20 percent, or 25 percent solution.

[42 FR 27582, May 31, 1977, as amended at 49 FR 2244, Jan. 19, 1984; 64 
FR 26286, May 14, 1999]