Code of Federal Regulations Title 21. Food and Drugs § 21.1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?

(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:

(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.

(1) “For Nonclinical Use Only” and

(2) With the Biohazard legend shown in § 1271.3(h).