[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.370]

[Page 739]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
--Table of Contents
 
  Subpart E_Additional Requirements for Establishments Described in   
                                 1271.10
 
Sec. 1271.370  Labeling.

    The following requirements apply in addition to Sec. Sec. 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 Sec. 1271.290(c);
    (2) Description of the type of HCT/P;
    (3) Expiration date, if any; and
    (4) Warnings required under Sec. Sec. 1271.60(d)(2), 1271,65(b)(2), 
or 1271.90(b), if applicable.
    (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.