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Code · CFR · Title 21 — Food and Drugs · Part 640 — Additional Standards for Human Blood and Blood Products · § 640.94

§ 640.94. Labeling.

101 words·~1 min read·/us/cfr/t21/s§ 640.94·

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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.” [42 FR 27583, May 31, 1977, as amended at 49 FR 2244, Jan. 19, 1984; 64 FR 26286, May 14, 1999]
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§ 640.94
Labeling.
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