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 Code of Federal Regulations (Last Updated: May 6, 2024)
 Title 21 - Food and Drugs
 Chapter I - Food and Drug Administration, Department of Health and Human Services
 SubChapter L - Regulations Under Certain Other Acts Administered by the Food and Drug Administration
 Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products
 Subpart E - Additional Requirements for Establishments Described in § 1271.10

  § 1271.370 - Labeling.

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  • § 1271.370 Labeling.

    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]