21 C.F.R. § 1271.370 Labeling.
Title 21 - Food and Drugs
The following requirements apply in addition to §§1271.55, 1271.60, 1271.65, and 1271.90: (a) You must label each HCT/P made available for distribution clearly and accurately. (b) The following information must appear on the HCT/P label: (1) Distinct identification code affixed to the HCT/P container, and assigned in accordance with §1271.290(c); (2) Description of the type of HCT/P; (3) Expiration date, if any; and (4) Warnings required under §1271.60(d)(2), §1271.65(b)(2), or §1271.90(b), if applicable and physically possible. If it is not physically possible to include these warnings on the label, the warnings must, instead, accompany the HCT/P. (c) The following information must either appear on the HCT/P label or accompany the HCT/P: (1) Name and address of the establishment that determines that the HCT/P meets release criteria and makes the HCT/P available for distribution; (2) Storage temperature; (3) Other warnings, where appropriate; and (4) Instructions for use when related to the prevention of the introduction, transmission, or spread of communicable diseases. [69 FR 68686, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005]
Title 21: Food and Drugs
PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart E—Additional Requirements for Establishments Described in § 1271.10
§ 1271.370 Labeling.
