21cfr1271

Food and Drug Administration, HHS

§ 1271.60

of this section must contain the following information:
(1) A statement that the communicable disease testing was performed
by a laboratory:
(i) Certified to perform such testing
on human specimens under the Clinical
Laboratory Improvement Amendments
of 1988 (42 U.S.C. 263a) and 42 CFR part
493; or
(ii) That has met equivalent requirements as determined by the Centers for
Medicare and Medicaid Services in accordance with those provisions;
(2) A listing and interpretation of the
results of all communicable disease
tests performed;
(3) The name and address of the establishment that made the donor-eligibility determination; and
(4) In the case of an HCT/P from a
donor who is ineligible based on screening and released under paragraph (b) of
§ 1271.65, a statement noting the reason(s) for the determination of ineligibility.
(c) Deletion of personal information.
The accompanying records required by
this section must not contain the donor’s name or other personal information that might identify the donor.
(d) Record retention requirements. (1)
You must maintain documentation of:
(i) Results and interpretation of all
testing for relevant communicable disease agents in compliance with
§§ 1271.80 and 1271.85, as well as the
name and address of the testing laboratory or laboratories;
(ii) Results and interpretation of all
donor screening for communicable diseases in compliance with § 1271.75; and
(iii) The donor-eligibility determination, including the name of the responsible person who made the determination and the date of the determination.
(2) All records must be accurate, indelible, and legible. Information on the
identity and relevant medical records
of the donor, as defined in § 1271.3(s),
must be in English or, if in another
language, must be retained and translated to English and accompanied by a
statement of authenticity by the translator that specifically identifies the
translated document.
(3) You must retain required records
and make them available for authorized inspection by or upon request from

FDA. Records that can be readily retrieved from another location by electronic means are considered ‘‘retained.’’
(4) You must retain the records pertaining to a particular HCT/P at least
10 years after the date of its administration, or if the date of administration is not known, then at least 10
years after the date of the HCT/P’s distribution, disposition, or expiration,
whichever is latest.
[69 FR 29830, May 25, 2004, as amended at 70
FR 29952, May 25, 2005]

§ 1271.60 What quarantine and other
requirements apply before the
donor-eligibility determination is
complete?
(a) Quarantine. You must keep an
HCT/P in quarantine, as defined in
§ 1271.3(q), until completion of the
donor-eligibility
determination
required by § 1271.50. You must quarantine semen from anonymous donors
until the retesting required under
§ 1271.85(d) is complete.
(b) Identification of HCT/Ps in quarantine. You must clearly identify as
quarantined an HCT/P that is in quarantine pending completion of a donoreligibility determination. The quarantined HCT/P must be easily distinguishable from HCT/Ps that are available for release and distribution.
(c) Shipping of HCT/Ps in quarantine.
If you ship an HCT/P before completion
of the donor-eligibility determination,
you must keep it in quarantine during
shipment. The HCT/P must be accompanied by records:
(1) Identifying the donor (e.g., by a
distinct identification code affixed to
the HCT/P container);
(2) Stating that the donor-eligibility
determination has not been completed;
and
(3) Stating that the product must not
be implanted, transplanted, infused, or
transferred until completion of the
donor-eligibility determination, except
under the terms of paragraph (d) of this
section.
(d) Use in cases of urgent medical need.
(1) This subpart C does not prohibit the
implantation, transplantation, infusion, or transfer of an HCT/P from a
donor for whom the donor-eligibility
determination is not complete if there

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§ 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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