---
kind: "section"
citation: "21 C.F.R. § 1271.370"
title: "21"
number: "1271.370"
heading: "Labeling."
url: "https://uscodex.org/cfr/21/1271.370"
---

# §1271.370. Labeling.


The following requirements apply in addition to §§ [1271.55](/cfr/21/1271.55.md), [1271.60](/cfr/21/1271.60.md), [1271.65](/cfr/21/1271.65.md), and [1271.90](/cfr/21/1271.90.md):

- (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)](/cfr/21/1271.290.md?p=c);
  - (2) Description of the type of HCT/P;
  - (3) Expiration date, if any; and
  - (4) Warnings required under [§ 1271.60(d)(2)](/cfr/21/1271.60.md?p=d-2), [§ 1271.65(b)(2)](/cfr/21/1271.65.md?p=b-2), or [§ 1271.90(c)](/cfr/21/1271.90.md?p=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.

## Notes

### Amendments

[69 FR 68686, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005; 81 FR 40518, June 22, 2016]

### Source

Source: 69 FR 68686, Nov. 24, 2004, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.

### Amendments

[69 FR 68686, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005; 81 FR 40518, June 22, 2016]