Code of Federal Regulations Title 21. Food and Drugs § 21.1271.265 Receipt, predistribution shipment, and distribution of an HCT/P

(1) Before making an HCT/P available for distribution, you must review manufacturing and tracking records pertaining to the HCT/P, and, on the basis of that record review, you must verify and document that the release criteria have been met. A responsible person must document and date the determination that an HCT/P is available for distribution.

(2) You must not make available for distribution an HCT/P that is in quarantine, is contaminated, is recovered from a donor who has been determined to be ineligible or for whom a donor-eligibility determination has not been completed (except as provided under §§ 1271.60, 1271.65, and 1271.90), or that otherwise does not meet release criteria designed to prevent communicable disease transmission.

(3) You must not make available for distribution any HCT/P manufactured under a departure from a procedure relevant to preventing risks of communicable disease transmission, unless a responsible person has determined that the departure does not increase the risk of communicable disease through the use of the HCT/P. You must record and justify any departure from a procedure at the time of its occurrence.

(1) Identification of the HCT/P and the establishment that supplied the HCT/P;

(2) Activities performed and the results of each activity;

(3) Date(s) of activity;

(4) Quantity of HCT/P subject to the activity;  and

(5) Disposition of the HCT/P (e.g., identity of consignee).