[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 732-733]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS--Table 
 
                 Subpart D_Current Good Tissue Practice
 
Sec.  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.

[[Page 733]]

    (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) 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 
Sec. Sec.  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.
    (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) 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.