21 C.F.R. § 640.84

Current through November 30, 2024

Section 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.

21 C.F.R. §640.84

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