Electronic Code of Federal Regulations

Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart H—Albumin (Human)

§640.84   Labeling.

In addition to the labeling requirements of §§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]