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21 CFR Part 1271 · Human Cells, Tissues, and Cellular and Tissue-Based Products

§ 1271.370 Labeling

Subpart E - Additional Requirements for Establishments Described in § 1271.10 Official text on eCFR Amendment history

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.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 1271.370

Form FDA 483 observations citing this section, fiscal years 2010–2024 (Human Tissue for Transplantation).

  • Clear and accurate label 3
  • Identification code affixed 1
  • Expiration date on label 1
  • Warnings on label 1
  • Name, address on label or documentation 1

FDA guidance that cites § 1271.370

Amendment history

Federal Register documents that created or amended this section.