21 C.F.R. § 1271.250 Labeling controls.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart D—Current Good Tissue Practice
§ 1271.250 Labeling controls.
