[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: 21CFR1271.390]

[Page 741-742]
 
                        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 F_Inspection and Enforcement of Establishments Described in   
                                 1271.10
 
Sec. 1271.390  Applicability.

    Source: 69 FR 68687, Nov. 24, 2004, unless otherwise noted.


    The provisions set forth in this subpart are applicable only to 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 to 
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

[[Page 742]]

Public Health Service Act, are not subject to the regulations set forth 
in this subpart.