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§ 1271.370 - Labeling.

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

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

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

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

Description of the type of HCT/P;

Expiration date, if any; and

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.

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

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

Storage temperature;

Other warnings, where appropriate; and

Instructions for use when related to the prevention of the introduction, transmission, or spread of communicable diseases.

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§ 1271.350 - Reporting.
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§ 1271.390 - Applicability.