---
kind: "section"
citation: "21 C.F.R. § 1271.250"
title: "21"
number: "1271.250"
heading: "Labeling controls."
url: "https://uscodex.org/cfr/21/1271.250"
---

# §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](/cfr/21/1271.55.md), [1271.60](/cfr/21/1271.60.md), [1271.65](/cfr/21/1271.65.md), [1271.90](/cfr/21/1271.90.md), [1271.290](/cfr/21/1271.290.md), and [1271.370](/cfr/21/1271.370.md), and that each HCT/P made available for distribution is accompanied by documentation of the donor eligibility determination as required under [§ 1271.55](/cfr/21/1271.55.md).

## Notes

### Source

Source: 69 FR 68681, 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.