21 CFR 640.84

§ 640.84 Labeling.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 640.84, § 640.84 Labeling, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88516
Permanent ID: ys:prov:88516@1
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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.