21 C.F.R. § 1271.250

Current through May 31, 2024
Section 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 .

21 C.F.R. §1271.250