[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 731-732]
 
                        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.  1271.220  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 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

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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.