[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1270.1]

[Page 687]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1270--HUMAN TISSUE INTENDED FOR TRANSPLANTATION--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 1270.1  Scope.


    (a) The regulations in this part apply to human tissue and to 
establishments or persons engaged in the recovery, screening, testing, 
processing, storage, or distribution of human tissue.
    (b) Regulations in this chapter as they apply to drugs, biologics, 
devices, or other FDA-regulated commodities do not apply to human 
tissue, except as specified in this part.
    (c) Regulations in this chapter do not apply to autologous human 
tissue.
    (d) Regulations in this chapter do not apply to hospitals or other 
clinical facilities that receive and store human tissue only for 
transplantation within the same facility.