§1271.60. What quarantine and other requirements apply before the donor-eligibility determination is complete?
21 C.F.R. § 1271.60
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.
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.
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:
Identifying the donor (e.g., by a distinct identification code affixed to the HCT/P container);
Stating that the donor-eligibility determination has not been completed; and
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.
Use in cases of urgent medical need.
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).
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:
The results of any donor screening required under § 1271.75 that has been completed;
A list of any screening or testing required under § 1271.75, 1271.80 or 1271.85 that has not yet been completed.
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.
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.
Notes, amendments, and revision history
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.