21 C.F.R. § 640.84 Labeling.
Title 21 - Food and Drugs
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]
Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart H—Albumin (Human)
§ 640.84 Labeling.
