[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: 21CFR1271.45]

[Page 722-723]
 
                        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. 1271.45  What requirements does this subpart contain?

    Effective Date Notes: 1. At 69 FR 29830, May 25, 2004, Sec. Sec. 
1271.45 through 1271.90 (Subpart C) were added effective May 25, 2005.


    (a) General. This subpart sets out requirements for determining 
donor eligibility, including donor screening and testing. The 
requirements contained in this subpart are a component of current good 
tissue practice (CGTP) requirements.
    (b) Donor-eligibility determination required. A donor-eligibility 
determination, based on donor screening and testing for relevant 
communicable disease agents and diseases, is required for all donors of 
cells or tissue used in HCT/Ps, except as provided under Sec. 1271.90. 
In the case of an embryo or of cells derived from an embryo, a donor-
eligibility determination is required for both the oocyte donor and the 
semen donor.

[[Page 723]]

    (c) Prohibition on use. An HCT/P must not be implanted, 
transplanted, infused, or transferred until the donor has been 
determined to be eligible, except as provided under Sec. Sec. 
1271.60(d), 1271.65(b), and 1271.90 of this subpart.
    (d) Applicability of requirements. If you are an establishment that 
performs any function described in this subpart, you must comply with 
the requirements contained in this subpart that are applicable to that 
function.

    Effective Date Note: At 69 FR 68681, Nov. 24, 2004, Sec. 1271.45 
was amended in paragraph (a) by adding a sentence after the second 
sentence, effective May 25, 2005. For the convenience of the user, the 
added text is set forth as follows:

Sec. 1271.45  What requirements does this subpart contain?

    (a) * * * Other CGTP requirements are set out in subpart D of this 
part.

                                * * * * *