21 CFR 1271.250 - Labeling controls.

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§ 1271.250 Labeling controls.

(a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design these procedures to ensure proper HCT/P identification and to prevent mix-ups.

(b) Verification. Procedures must include verification of label accuracy, legibility, and integrity.

(c) Labeling requirements. Procedures must ensure that each HCT/P is labeled in accordance with all applicable labeling requirements, including those in §§ 1271.55, 1271.60, 1271.65, 1271.90, 1271.290, and 1271.370, and that each HCT/P made available for distribution is accompanied by documentation of the donor eligibility determination as required under § 1271.55.

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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    1. 80 FR 66844 - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period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      Submit either electronic or written comments on the draft guidance by April 29, 2016.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