GroundRules
21 CFR 1271.370: Labeling.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
- PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
- Subpart E—Additional Requirements for Establishments Described in § 1271.10
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON