[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.90]

[Page 728-729]
 
                        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, originally 
exempt under paragraph (a)(1) or (a)(2) 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
    (ii) Appropriate measures are taken to screen and test the donor(s) 
before transfer to the recipient.
    (b) Required labeling. You must prominently label an HCT/P listed in 
paragraph (a) of this section:
    (1) ``FOR AUTOLOGOUS USE ONLY,'' if it is stored for autologous use;
    (2) ``NOT EVALUATED FOR INFECTIOUS SUBSTANCES'' and ``WARNING: 
Advise patient of communicable disease risks,'' unless you have 
performed all otherwise applicable screening and testing under 
Sec. Sec. 1271.75, 1271.80, and 1271.85; and
    (3) 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: Reactive test 
results for (name of disease agent or disease)'' if the results of any 
screening or testing performed indicate:

[[Page 729]]

    (i) The presence of relevant communicable disease agents and/or
    (ii) Risk factors for or clinical evidence of relevant communicable 
disease agents or diseases.