Code of Federal Regulations Title 21. Food and Drugs § 21.1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete?

(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.

(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:

(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.