21 CFR § 1271.60 - What quarantine and other requirements apply before the donor-eligibility determination is complete?

---
identifier: "/us/cfr/t21/s1271.60"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1271.60 - What quarantine and other requirements apply before the donor-eligibility determination is complete?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1271.60"
section_name: "What quarantine and other requirements apply before the donor-eligibility determination is complete?"
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"
---


# 1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete?

(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.