Section 1271.370 - LabelingThe 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;(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