[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: 21CFR1270.35]

[Page 713]
 
                        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 C_Procedures and Records
 
Sec. 1270.35  Specific records.

    Records shall be maintained that include, but are not limited to:
    (a) Documentation of results and interpretation of all required 
infectious disease tests;
    (b) Information on the identity and relevant medical records of the 
donor, as required by Sec. 1270.21(e) in English or, if in another 
language translated to English and accompanied by a statement of 
authenticity by the translator which specifically identifies the 
translated document;
    (c) Documentation of the receipt and/or distribution of human 
tissue; and
    (d) Documentation of the destruction or other disposition of human 
tissue.

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