21 CFR 1271.65
How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
21 CFR 1271.65 is the regulation titled “How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 6 FDA warning letters have cited it.
- Letters citing it
- 6 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.155, in 6 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are biologics letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 1271.65 most often, as written in the letters.
- 1 letterFailure to collect donor specimens for testing for relevant communicable diseases at the time of recovery of the cells or tissue from the donor; or for oocyte donors, within 30 days prior to oocyte recovery or up to…
- 1 letterFailure to include in the summary of records a statement noting the reason(s) for the determination of ineligibility in the case of an HCT/P from a donor who is ineligible based on screening and released under 21 CFR…
- 1 letterFailure to include in the summary of records a statement noting the reason(s) for the determination of ineligibility in the case of an HCT/P from a donor who is ineligible based on screening and released under 21 CFR…
The regulation
Read the text of 21 CFR 1271.65 (eCFR, as of Sep 1, 2026)
(a) Storage. If you are the establishment that stores the HCT/P, you must store or identify HCT/Ps from donors who have been determined to be ineligible in a physically separate area clearly identified for such use, or follow other procedures, such as automated designation, that are adequate to prevent improper release until destruction or other disposition of the HCT/P in accordance with paragraph (b) or (c) of this section.
(b) Limited uses of HCT/P from ineligible donor. (1) An HCT/P from a donor who has been determined to be ineligible, based on the results of required testing and/or screening, is not prohibited by subpart C of this part from use for implantation, transplantation, infusion, or transfer under the following circumstances:
(i) The HCT/P is for allogeneic use in a first-degree or second-degree blood relative;
(ii) The HCT/P consists of reproductive cells or tissue from a directed reproductive donor, as defined in § 1271.3(l); or
(iii) There is a documented urgent medical need as defined in § 1271.3(u).
(2) You must prominently label an HCT/P made available for use under the provisions of paragraph (b)(1) of this section with the Biohazard legend shown in § 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).” The HCT/P must be accompanied by the records required under § 1271.55.
(3) If you are the establishment that manufactured an HCT/P used under the provisions of paragraph (b)(1) of this section, you must document that you notified the physician using the HCT/P of the results of testing and screening.
(c) Nonclinical use. You may make available for nonclinical purposes an HCT/P from a donor who has been determined to be ineligible, based on the results of required testing and/or screening, provided that it is labeled:
(1) “For Nonclinical Use Only” and
(2) With the Biohazard legend shown in § 1271.3(h).
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.65.
- 21 CFR 1271.155Exemptions and alternatives6 letters cite both
- 21 CFR 1271.60What quarantine and other requirements apply before the donor-eligibility determination is complete?6 letters cite both
- 21 CFR 1271.75How do I screen a donor?6 letters cite both
- 21 CFR 1271.80What are the general requirements for donor testing?6 letters cite both
- 21 CFR 1271.85What donor testing is required for different types of cells and tissues?6 letters cite both
- 21 CFR 1271.90Are there other exceptions and what labeling requirements apply?6 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?5 letters cite both
- 21 CFR 1271.50How do I determine whether a donor is eligible?5 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 1271.65 that FDA posted most recently.
- BiologicsView Central Coast Multispecialty Medical Group, Inc.human cells, tissues, and cellular and tissue-based products (HCT/Ps)IssuedJan 29, 2026PostedFeb 10, 2026
- BiologicsView Conceive Fertility Centerreproductive cells or tissue (oocytes and semen)IssuedJan 27, 2026PostedFeb 10, 2026
- BiologicsView InVia Fertility Specialists, PLLCReproductive cells and tissues (oocytes, semen, embryos)IssuedJun 13, 2025PostedJul 1, 2025
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