StacksVerified U.S. regulatory reference

21 CFR §1271.370

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The following requirements apply in addition to §§ 1271.55, 1271.60, 1271.65, and 1271.90:
  1. (a)You must label each HCT/P made available for distribution clearly and accurately.
  2. (b)The following information must appear on the HCT/P label:
    1. (1)Distinct identification code affixed to the HCT/P container, and assigned in accordance with § 1271.290(c);
    2. (2)Description of the type of HCT/P;
    3. (3)Expiration date, if any; and
    4. (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.
  3. (c)The following information must either appear on the HCT/P label or accompany the HCT/P:
    1. (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. (2)Storage temperature;
    3. (3)Other warnings, where appropriate; and
    4. (4)Instructions for use when related to the prevention of the introduction, transmission, or spread of communicable diseases.