§1271.370. Labeling.
21 C.F.R. § 1271.370
You must label each HCT/P made available for distribution clearly and accurately.
The following information must appear on the HCT/P label:
Distinct identification code affixed to the HCT/P container, and assigned in accordance with § 1271.290(c);
Description of the type of HCT/P;
Expiration date, if any; and
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.
The following information must either appear on the HCT/P label or accompany the HCT/P:
Name and address of the establishment that determines that the HCT/P meets release criteria and makes the HCT/P available for distribution;
Storage temperature;
Other warnings, where appropriate; and
Instructions for use when related to the prevention of the introduction, transmission, or spread of communicable diseases.
Notes, amendments, and revision history
Amendments
[69 FR 68686, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005; 81 FR 40518, June 22, 2016]
Source
Source: 69 FR 68686, Nov. 24, 2004, unless otherwise noted.
Authority
Authority: 42 U.S.C. 216, 243, 263a, 264, 271.
Source
Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.
Amendments
[69 FR 68686, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005; 81 FR 40518, June 22, 2016]