21 CFR 1271.60
What quarantine and other requirements apply before the donor-eligibility determination is complete?
21 CFR 1271.60 is the regulation titled “What quarantine and other requirements apply before the donor-eligibility determination is complete?” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 13 FDA warning letters have cited it.
- Letters citing it
- 13 since 2021
- Jan 1 to Oct 30, 2026
- 3 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.75, in 13 letters
- Closed out
- 8% 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 1271.60 most often, as written in the letters.
- 1 letterFailure to test a specimen from an anonymous semen donor for evidence of infection due to relevant communicable disease agents [21 CFR 1271.80(a)]; and/or failure to retest anonymous semen donors at least six months…
The regulation
Read the text of 21 CFR 1271.60 (eCFR, as of Sep 1, 2026)
(a) Quarantine. You must keep an HCT/P in quarantine, as defined in § 1271.3(q), until completion of the donor-eligibility determination required by § 1271.50. You must quarantine semen from anonymous donors until the retesting required under § 1271.85(d) is complete.
(b) Identification of HCT/Ps in quarantine. You must clearly identify as quarantined an HCT/P that is in quarantine pending completion of a donor-eligibility determination. The quarantined HCT/P must be easily distinguishable from HCT/Ps that are available for release and distribution.
(c) Shipping of HCT/Ps in quarantine. If you ship an HCT/P before completion of the donor-eligibility determination, you must keep it in quarantine during shipment. The HCT/P must be accompanied by records:
(1) Identifying the donor (e.g., by a distinct identification code affixed to the HCT/P container);
(2) Stating that the donor-eligibility determination has not been completed; and
(3) Stating that the product must not be implanted, transplanted, infused, or transferred until completion of the donor-eligibility determination, except under the terms of paragraph (d) of this section.
(d) Use in cases of urgent medical need. (1) This subpart C does not prohibit the implantation, transplantation, infusion, or transfer of an HCT/P from a donor for whom the donor-eligibility determination is not complete if there is a documented urgent medical need for the HCT/P, as defined in § 1271.3(u).
(2) If you make an HCT/P available for use under the provisions of paragraph (d)(1) of this section, you must prominently label it “NOT EVALUATED FOR INFECTIOUS SUBSTANCES,” and “ WARNING: Advise patient of communicable disease risks.” The following information must accompany the HCT/P:
(i) The results of any donor screening required under § 1271.75 that has been completed;
(ii) The results of any testing required under § 1271.80 or 1271.85 that has been completed; and
(iii) A list of any screening or testing required under § 1271.75, 1271.80 or 1271.85 that has not yet been completed.
(3) If you are the establishment that manufactured an HCT/P used under the provisions of paragraph (d)(1) of this section, you must document that you notified the physician using the HCT/P that the testing and screening were not complete.
(4) In the case of an HCT/P used for an urgent medical need under the provisions of paragraph (d)(1) of this section, you must complete the donor-eligibility determination during or after the use of the HCT/P, and you must inform the physician of the results of the determination.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.60.
- 21 CFR 1271.75How do I screen a donor?13 letters cite both
- 21 CFR 1271.155Exemptions and alternatives12 letters cite both
- 21 CFR 1271.85What donor testing is required for different types of cells and tissues?12 letters cite both
- 21 CFR 1271.90Are there other exceptions and what labeling requirements apply?12 letters cite both
- 21 CFR 1271.80What are the general requirements for donor testing?11 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?10 letters cite both
- 21 CFR 1271.45What requirements does this subpart contain?9 letters cite both
- 21 CFR 1271.47What procedures must I establish and maintain?9 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 1271.60 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 Louisville Reproductive Centerreproductive cells and tissue (semen, oocytes, embryos)IssuedJan 23, 2026PostedFeb 10, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.