Labeling.

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(c), 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; 81 FR 40518, June 22, 2016]