---
kind: "section"
citation: "21 C.F.R. § 1271.265"
title: "21"
number: "1271.265"
heading: "Receipt, predistribution shipment, and distribution of an HCT/P."
url: "https://uscodex.org/cfr/21/1271.265"
---

# §1271.265. Receipt, predistribution shipment, and distribution of an HCT/P.

- (a) **Receipt.** You must evaluate each incoming HCT/P for the presence and significance of microorganisms and inspect for damage and contamination. You must determine whether to accept, reject, or place in quarantine each incoming HCT/P, based upon pre-established criteria designed to prevent communicable disease transmission.
- (b) **Predistribution shipment.** If you ship an HCT/P within your establishment or between establishments (e.g., procurer to processor) and the HCT/P is not available for distribution as described in [paragraph (c)](#c) of this section, you must first determine and document whether pre-established criteria designed to prevent communicable disease transmission have been met, and you must ship the HCT/P in quarantine.
- (c) **Availability for distribution.**
  - (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](/cfr/21/1271.60.md), [1271.65](/cfr/21/1271.65.md), and [1271.90](/cfr/21/1271.90.md)), 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.
- (d) **Packaging and shipping.** Packaging and shipping containers must be designed and constructed to protect the HCT/P from contamination. For each type of HCT/P, you must establish appropriate shipping conditions to be maintained during transit.
- (e) **Procedures.** You must establish and maintain procedures, including release criteria, for the activities in [paragraphs (a) through (d)](#a..d) of this section. You must document these activities. Documentation must include:
  - (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).
- (f) **Return to inventory.** You must establish and maintain procedures to determine if an HCT/P that is returned to your establishment is suitable to be returned to inventory.

## Notes

### Source

Source: 69 FR 68681, Nov. 24, 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.