[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 736]
 
                        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 
 
  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.  1271.60(d)(2), Sec.  
1271.65(b)(2), or Sec.  1271.90(b), 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.

[69 FR 68686, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005]