[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 743]
 
                        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 E_Additional Requirements for Establishments Described in   
                                 1271.10
 
Sec.  1271.330  Applicability.

    Source: 69 FR 68686, Nov. 24, 2004, unless otherwise noted.


    The provisions set forth in this subpart are being implemented for 
nonreproductive HCT/Ps described in Sec.  1271.10 and regulated solely 
under section 361 of the Public Health Service Act and the regulations 
in this part, and for the establishments that manufacture those HCT/Ps. 
HCT/Ps that are drugs or devices regulated under the act, or are 
biological products regulated under section 351 of the Public Health 
Service Act, are not subject to the regulations set forth in this 
subpart.