Regulation Text
(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 .
Authority
42 U.S.C. 216,243,263a,264,271.
Related Guidelines (3)
Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors (Status: Final)
→Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry (Status: Final)
→Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for Industry (Status: Final)
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