[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 742]
 
                        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 D_Current Good Tissue Practice
 
Sec.  1271.290  Tracking.

    (a) General. If you perform any step in the manufacture of an HCT/P 
in which you handle the HCT/P, you must track each such HCT/P in 
accordance with this section, to facilitate the investigation of actual 
or suspected transmission of communicable disease and take appropriate 
and timely corrective action.
    (b) System of HCT/P tracking. (1) You must establish and maintain a 
system of HCT/P tracking that enables the tracking of all HCT/Ps from:
    (i) The donor to the consignee or final disposition; and
    (ii) The consignee or final disposition to the donor.
    (2) Alternatively, if you are an establishment that performs some 
but not all of the steps in the manufacture of an HCT/P in which you 
handle the HCT/P, you may participate in a system of HCT/P tracking 
established and maintained by another establishment responsible for 
other steps in the manufacture of the same HCT/P, provided that the 
tracking system complies with all the requirements of this section.
    (c) Distinct identification code. As part of your tracking system, 
you must ensure: That each HCT/P that you manufacture is assigned and 
labeled with a distinct identification code, e.g., alphanumeric, that 
relates the HCT/P to the donor and to all records pertaining to the HCT/
P; and that labeling includes information designed to facilitate 
effective tracking, using the distinct identification code, from the 
donor to the recipient and from the recipient to the donor. Except as 
described in Sec.  1271.55(a)(1), you must create such a code 
specifically for tracking, and it may not include an individual's name, 
social security number, or medical record number. You may adopt a 
distinct identification code assigned by another establishment engaged 
in the manufacturing process, or you may assign a new code. If you 
assign a new code to an HCT/P, you must establish and maintain 
procedures for relating the new code to the old code.
    (d) Tracking from consignee to donor. As part of your tracking 
system, you must establish and maintain a method for recording the 
distinct identification code and type of each HCT/P distributed to a 
consignee to enable tracking from the consignee to the donor.
    (e) Tracking from donor to consignee or final disposition. As part 
of your tracking system, you must establish and maintain a method for 
documenting the disposition of each of your HCT/Ps, to enable tracking 
from the donor to the consignee or final disposition. The information 
you maintain must permit the prompt identification of the consignee of 
the HCT/P, if any.
    (f) Consignees. At or before the time of distribution of an HCT/P to 
a consignee, you must inform the consignee in writing of the 
requirements in this section and of the tracking system that you have 
established and are maintaining to comply with these requirements.
    (g) Requirements specific to dura mater donors. You must archive 
appropriate specimens from each donor of dura mater, under appropriate 
storage conditions, and for the appropriate duration, to enable testing 
of the archived material for evidence of transmissible spongiform 
encephalopathy, and to enable appropriate disposition of any affected 
nonadministered dura mater tissue, if necessary.

[69 FR 68681, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005]