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?

(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).