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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Food and Drug Administration, HHS

§ 1271.350

(c) Review and evaluation of complaints. You must review and evaluate
each complaint relating to core CGTP
requirements to determine if the complaint is related to an HCT/P deviation
or to an adverse reaction, and to determine if a report under § 1271.350 or another applicable regulation is required.
As soon as practical, you must review,
evaluate, and investigate each complaint that represents an event required to be reported to FDA, as described in § 1271.350. You must review
and evaluate a complaint relating to
core CGTP requirements that does not
represent an event required to be reported to determine whether an investigation is necessary; an investigation
may include referring a copy of the
complaint to another establishment
that performed manufacturing steps
pertinent to the complaint. When no
investigation is made, you must maintain a record that includes the reason
no investigation was made, and the
name of the individual(s) responsible
for the decision not to investigate.

Subpart E—Additional Requirements for Establishments Described in § 1271.10
SOURCE: 69 FR 68686, Nov. 24, 2004, unless
otherwise noted.

§ 1271.330

Applicability.

The provisions set forth in this subpart are being implemented for nonreproductive HCT/Ps described in
§ 1271.10 and regulated solely under section 361 of the Public Health Service
Act and the regulations in this part,
and for the establishments that manufacture those HCT/Ps. HCT/Ps that are
drugs or devices regulated under the
act, or are biological products regulated under section 351 of the Public
Health Service Act, are not subject to
the regulations set forth in this subpart.
§ 1271.350

Reporting.

(a) Adverse reaction reports. (1) You
must investigate any adverse reaction
involving a communicable disease related to an HCT/P that you made available for distribution. You must report

to FDA an adverse reaction involving a
communicable disease if it:
(i) Is fatal;
(ii) Is life-threatening;
(iii) Results in permanent impairment of a body function or permanent
damage to body structure; or
(iv) Necessitates medical or surgical
intervention, including hospitalization.
(2) You must submit each report on a
Form FDA–3500A to the address in
paragraph (a)(5) of this section within
15 calendar days of initial receipt of
the information.
(3) You must, as soon as practical, investigate all adverse reactions that are
the subject of these 15-day reports and
must submit followup reports within 15
calendar days of the receipt of new information or as requested by FDA. If
additional information is not obtainable, a followup report may be required
that describes briefly the steps taken
to seek additional information and the
reasons why it could not be obtained.
(4) You may obtain copies of the reporting form (FDA–3500A) from the
Center for Biologics Evaluation and
Research (see address in paragraph
(a)(5) of this section). Electronic Form
FDA–3500A may be obtained at http://
www.fda.gov/medwatch or at http://
www.hhs.gov/forms.
(5) You must submit two copies of
each report described in this paragraph
to the Center for Biologics Evaluation
and Research (HFM–210), Food and
Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852–
1448. FDA may waive the requirement
for the second copy in appropriate circumstances.
(b) Reports of HCT/P deviations. (1)
You must investigate all HCT/P deviations related to a distributed HCT/P
for which you performed a manufacturing step.
(2) You must report any such HCT/P
deviation relating to the core CGTP requirements, if the HCT/P deviation occurred in your facility or in a facility
that performed a manufacturing step
for you under contract, agreement, or
other arrangement. Each report must
contain a description of the HCT/P deviation, information relevant to the
event and the manufacture of the HCT/
P involved, and information on all follow-up actions that have been or will

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