[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.390]

[Page 739]
 
                        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.

    Effective Date Note: At 69 FR 68687, Nov. 24, 2005, Sec. Sec. 
1271.390--1271.440 (Subpart F) were added, effective May 25, 2005.


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