21 CFR § 1271.45 - What requirements does this subpart contain?

---
identifier: "/us/cfr/t21/s1271.45"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1271.45 - What requirements does this subpart contain?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1271.45"
section_name: "What requirements does this subpart contain?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "L"
subchapter_name: "REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION"
part_number: "1271"
part_name: "HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 216, 243, 263a, 264, 271."
regulatory_source: "66 FR 5466, Jan. 19, 2001, unless otherwise noted."
cfr_part: "1271"
---


# 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 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. 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), 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.

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