Labeling controls.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Regulations Under Certain Other Acts Administered by the Food and Drug Administration
  6. Human Cells, Tissues, and Cellular and Tissue-Based Products
  7. Current Good Tissue Practice
  8. 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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