§ 1271.370. Labeling.

186 words·~1 min read·/us/cfr/t21/s§ 1271.370·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

The following requirements apply in addition to §§ 1271.55, 1271.60, 1271.65, and 1271.90:

(a)You must label each HCT/P made available for distribution clearly and accurately.

(b)The following information must appear on the HCT/P label:

(1)Distinct identification code affixed to the HCT/P container, and assigned in accordance with § 1271.290(c);

(2)Description of the type of HCT/P;

(3)Expiration date, if any; and

(4)Warnings required under § 1271.60(d)(2), § 1271.65(b)(2), or § 1271.90(c), if applicable and physically possible. If it is not physically possible to include these warnings on the label, the warnings must, instead, accompany the HCT/P.

(c)The following information must either appear on the HCT/P label or accompany the HCT/P:

(1)Name and address of the establishment that determines that the HCT/P meets release criteria and makes the HCT/P available for distribution;

(2)Storage temperature;

(3)Other warnings, where appropriate; and

(4)Instructions for use when related to the prevention of the introduction, transmission, or spread of communicable diseases. [69 FR 68686, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005; 81 FR 40518, June 22, 2016]

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§ 1271.370

Labeling.

Fed. Reg.×2

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