21cfr1271

§ 1271.290

21 CFR Ch. I (4–1–06 Edition)

§ 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
§ 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 identifica-

tion 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]

§ 1271.320 Complaint file.
(a) Procedures. You must establish
and maintain procedures for the review, evaluation, and documentation of
complaints as defined in §1271.3(aa), relating to core current good tissue practice (CGTP) requirements, and the investigation of complaints as appropriate.
(b) Complaint file. You must maintain
a record of complaints that you receive
in a file designated for complaints. The
complaint file must contain sufficient
information about each complaint for
proper review and evaluation of the
complaint (including the distinct identification code of the HCT/P that is the
subject of the complaint) and for determining whether the complaint is an
isolated event or represents a trend.
You must make the complaint file
available for review and copying upon
request from FDA.

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