[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.220]

[Page 736-737]
 
                        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 of Contents
 
                 Subpart D_Current Good Tissue Practice
 
Sec. 1271.220  Processing and process controls.

    (a) General. If you are an establishment that processes HCT/Ps, you 
must process each HCT/P in a way that does not cause contamination or 
cross-contamination during processing, and that prevents the 
introduction, transmission, or spread of communicable disease through 
the use of the HCT/P.
    (b) Pooling. Human cells or tissue from two or more donors must not 
be pooled (placed in physical contact or mixed in a single receptacle) 
during manufacturing.
    (c) In-process control and testing. You must ensure that specified 
requirements, consistent with paragraph (a) of this section, for in-
process controls are met, and that each in-process HCT/P is

[[Page 737]]

controlled until the required inspection and tests or other verification 
activities have been completed, or necessary approvals are received and 
documented. Sampling of in-process HCT/Ps must be representative of the 
material to be evaluated.
    (d) Dura mater. (1) When there is a published validated process that 
reduces the risk of transmissible spongiform encephalopathy, you must 
use this process for dura mater (or an equivalent process that you have 
validated), unless following this process adversely affects the clinical 
utility of the dura mater.
    (2) When you use a published validated process, you must verify such 
a process in your establishment.