---
kind: "section"
citation: "21 C.F.R. § 1271.45"
title: "21"
number: "1271.45"
heading: "What requirements does this subpart contain?"
url: "https://uscodex.org/cfr/21/1271.45"
---

# §1271.45. What requirements does this subpart contain?

- (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. Other CGTP requirements are set out in [subpart D](/cfr/21/subpartD.md) of this part.
- (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 [§ 1271.90](/cfr/21/1271.90.md). 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.
- (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 §§ [1271.60(d)](/cfr/21/1271.60.md?p=d), [1271.65(b)](/cfr/21/1271.65.md?p=b), and [1271.90](/cfr/21/1271.90.md) 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.

## Notes

### Amendments

[69 FR 29830, May 25, 2004, as amended at 69 FR 68681, Nov. 24, 2004]

### Source

Source: 69 FR 29830, May 25, 2004, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.

### Amendments

[69 FR 29830, May 25, 2004, as amended at 69 FR 68681, Nov. 24, 2004]