[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.65]

[Page 727-728]
 
                        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 C_Donor Eligibility
 
Sec. 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 Sec. 1271.3(l); or
    (iii) There is a documented urgent medical need as defined in Sec. 
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 Sec. 1271.3(h) with the statement ``WARNING: Advise 
patient of communicable disease risks,'' and, in the case of reactive 
test results, ``WARNING:

[[Page 728]]

Reactive test results for (name of disease agent or disease).'' The HCT/
P must be accompanied by the records required under Sec. 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 Sec. 1271.3(h).