21 CFR 1271.370 - Labeling.

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§ 1271.370 Labeling.
Link to an amendment published at 81 FR 40518, June 22, 2016.

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(b), 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]

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United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1271 after this date.

  • 2015-10-30; vol. 80 # 210 - Friday, October 30, 2015
    1. 80 FR 66844 - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification; reopening of the comment period.
      Submit either electronic or written comments on the draft guidance by April 29, 2016.
      21 CFR Part 1271