[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: 21CFR1271.90]

[Page 730-731]
 
                        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. 1271.90  Are there exceptions from the requirement of 
determining donor eligibility, and what labeling

requirements apply?

    (a) Donor-eligibility determination not required. You are not 
required to make a donor-eligibility determination under Sec. 1271.50 
or to perform donor screening or testing under Sec. Sec. 1271.75, 
1271.80 and 1271.85 for:
    (1) Cells and tissues for autologous use; or
    (2) Reproductive cells or tissue donated by a sexually intimate 
partner of the recipient for reproductive use; or
    (3) Cryopreserved cells or tissue for reproductive use, other than 
embryos, originally exempt under paragraphs (a)(1) or (a)(2) of this 
section at the time of donation, that are subsequently intended for 
directed donation, provided that
    (i) Additional donations are unavailable, for example, due to the 
infertility or health of a donor of the cryopreserved reproductive cells 
or tissue; and

[[Page 731]]

    (ii) Appropriate measures are taken to screen and test the donor(s) 
before transfer to the recipient.
    (4) A cryopreserved embryo, originally exempt under paragraph (a)(2) 
of this section at the time of cryopreservation, that is subsequently 
intended for directed or anonymous donation. When possible, appropriate 
measures should be taken to screen and test the semen and oocyte donors 
before transfer of the embryo to the recipient.
    (b) Required labeling. As applicable, you must prominently label an 
HCT/P described in paragraph (a) of this section as follows:
    (1) ``FOR AUTOLOGOUS USE ONLY,'' if it is stored for autologous use.
    (2) ``NOT EVALUATED FOR INFECTIOUS SUBSTANCES,'' unless you have 
performed all otherwise applicable screening and testing under 
Sec. Sec. 1271.75, 1271.80, and 1271.85. This paragraph does not apply 
to reproductive cells or tissue labeled in accordance with paragraph 
(b)(6) of this section.
    (3) Unless the HCT/P is for autologous use only, ``WARNING: Advise 
recipient of communicable disease risks,''
    (i) When the donor-eligibility determination under Sec. 1271.50(a) 
is not performed or is not completed; or
    (ii) If the results of any screening or testing performed indicate:
    (A) The presence of relevant communicable disease agents and/or
    (B) Risk factors for or clinical evidence of relevant communicable 
disease agents or diseases.
    (4) With the Biohazard legend shown in Sec. 1271.3(h), if the 
results of any screening or testing performed indicate:
    (i) The presence of relevant communicable disease agents and/or
    (ii) Risk factors for or clinical evidence of relevant communicable 
disease agents or diseases.
    (5) ``WARNING: Reactive test results for (name of disease agent or 
disease),'' in the case of reactive test results.
    (6) ``Advise recipient that screening and testing of the donor(s) 
were not performed at the time of cryopreservation of the reproductive 
cells or tissue, but have been performed subsequently,'' for paragraphs 
(a)(3) or (a)(4) of this section.

[69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005]