21 CFR Part 640 · Additional Standards for Human Blood and Blood Products

§ 640.84 Labeling

Subpart H - Albumin (Human) Official text on eCFR Amendment history

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.

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Amendment history

Federal Register documents that created or amended this section.