21 CFR § 1271.250 - Labeling controls.

---
identifier: "/us/cfr/t21/s1271.250"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1271.250 - Labeling controls."
title_number: 21
title_name: "Food and Drugs"
section_number: "1271.250"
section_name: "Labeling controls."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "L"
subchapter_name: "REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION"
part_number: "1271"
part_name: "HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 216, 243, 263a, 264, 271."
regulatory_source: "66 FR 5466, Jan. 19, 2001, unless otherwise noted."
cfr_part: "1271"
---


# 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.