21cfr1271

§ 1271.65

21 CFR Ch. I (4–1–06 Edition)

is a documented urgent medical need
for the HCT/P, as defined in § 1271.3(u).
(2) If you make an HCT/P available
for use under the provisions of paragraph (d)(1) of this section, you must
prominently label it ‘‘NOT EVALUATED
FOR
INFECTIOUS
SUBSTANCES,’’ and ‘‘ WARNING: Advise
patient
of
communicable
disease
risks.’’ The following information must
accompany the HCT/P:
(i) The results of any donor screening
required under § 1271.75 that has been
completed;
(ii) The results of any testing required under § 1271.80 or 1271.85 that has
been completed; and
(iii) A list of any screening or testing
required under § 1271.75, 1271.80 or
1271.85 that has not yet been completed.
(3) If you are the establishment that
manufactured an HCT/P used under the
provisions of paragraph (d)(1) of this
section, you must document that you
notified the physician using the HCT/P
that the testing and screening were not
complete.
(4) In the case of an HCT/P used for
an urgent medical need under the provisions of paragraph (d)(1) of this section, you must complete the donor-eligibility determination during or after
the use of the HCT/P, and you must inform the physician of the results of the
determination.
§ 1271.65 How do I store an HCT/P
from a donor determined to be ineligible, and what uses of the HCT/
P are not prohibited?
(a) Storage. If you are the establishment that stores the HCT/P, you must
store or identify HCT/Ps from donors
who have been determined to be ineligible in a physically separate area
clearly identified for such use, or follow other procedures, such as automated designation, that are adequate
to prevent improper release until destruction or other disposition of the
HCT/P in accordance with paragraph
(b) or (c) of this section.
(b) Limited uses of HCT/P from ineligible donor. (1) An HCT/P from a donor
who has been determined to be ineligible, based on the results of required
testing and/or screening, is not prohibited by subpart C of this part from use

for implantation, transplantation, infusion, or transfer under the following
circumstances:
(i) The HCT/P is for allogeneic use in
a first-degree or second-degree blood
relative;
(ii) The HCT/P consists of reproductive cells or tissue from a directed reproductive
donor,
as
defined
in
§ 1271.3(l); or
(iii) There is a documented urgent
medical need as defined in § 1271.3(u).
(2) You must prominently label an
HCT/P made available for use under the
provisions of paragraph (b)(1) of this
section with the Biohazard legend
shown in § 1271.3(h) with the statement
‘‘WARNING: Advise patient of communicable disease risks,’’ and, in the case
of reactive test results, ‘‘WARNING:
Reactive test results for (name of disease agent or disease).’’ The HCT/P
must be accompanied by the records required under § 1271.55.
(3) If you are the establishment that
manufactured an HCT/P used under the
provisions of paragraph (b)(1) of this
section, you must document that you
notified the physician using the HCT/P
of the results of testing and screening.
(c) Nonclinical use. You may make
available for nonclinical purposes an
HCT/P from a donor who has been determined to be ineligible, based on the
results of required testing and/or
screening, provided that it is labeled:
(1) ‘‘For Nonclinical Use Only’’ and
(2) With the Biohazard legend shown
in § 1271.3(h).
§ 1271.75 How do I screen a donor?
(a) All donors. Except as provided
under § 1271.90, if you are the establishment that performs donor screening,
you must screen a donor of cells or tissue by reviewing the donor’s relevant
medical records for:
(1) Risk factors for, and clinical evidence of, relevant communicable disease agents and diseases, including:
(i) Human immunodeficiency virus;
(ii) Hepatitis B virus;
(iii) Hepatitis C virus;
(iv) Human transmissible spongiform
encephalopathy, including CreutzfeldtJakob disease;
(v) Treponema pallidum; and
(2) Communicable disease risks associated with xenotransplantation.

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