[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: 21CFR1270.1]

[Page 709-710]
 
                        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.




                      Subpart A_General Provisions

Sec.
1270.1 Scope.
1270.3 Definitions.

                  Subpart B_Donor Screening and Testing

1270.21 Determination of donor suitability for human tissue intended for 
          transplantation.

                    Subpart C_Procedures and Records

1270.31 Written procedures.
1270.33 Records, general requirements.
1270.35 Specific records.

              Subpart D_Inspection of Tissue Establishments

1270.41 Inspections.
1270.42 Human tissue offered for import.
1270.43 Retention, recall, and destruction of human tissue.

                              Subpart C_xxx

1270.45 xxx

    Authority: 42 U.S.C. 216, 243, 264, 271.

    Source: 62 FR 40444, July 29, 1997, unless otherwise noted.



    (a) The regulations in this part apply to human tissue and to 
establishments or persons engaged in the recovery,

[[Page 710]]

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.