[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1270.33]

[Page 680-681]
 
                        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. 1270.33  Records, general requirements.

    (a) Records shall be maintained concurrently with the performance of 
each significant step required in this part in the performance of 
infectious disease screening and testing of donors of human tissue. All 
records shall be accurate, indelible, and legible. The records shall 
identify the person performing the work, the dates of the various 
entries, and shall be as detailed as necessary to provide a complete 
history of the work performed and to relate the records to the 
particular tissue involved.
    (b) All human tissue shall be quarantined until the following 
criteria for donor suitability are satisfied:
    (1) All infectious disease testing under Sec. 1270.21 has been 
completed, reviewed by the responsible person, and found to be negative; 
and
    (2) Donor screening has been completed, reviewed by the responsible 
person, and determined to assure freedom from risk factors for and 
clinical evidence of HIV infection, hepatitis B, and hepatitis C.
    (c) All human tissue processed or shipped prior to determination of 
donor suitability must be under quarantine, accompanied by records 
assuring identification of the donor and indicating that the tissue has 
not been determined to be suitable for transplantation.
    (d) All human tissue determined to be suitable for transplantation 
must be accompanied by a summary of records, or copies of such original 
records, documenting that all infectious disease testing and screening 
under Sec. 1270.21 has been completed, reviewed by the responsible 
person, and found to be

[[Page 681]]

negative, and that the tissue has been determined to be suitable for 
transplantation.
    (e) Human tissue shall be quarantined until the tissue is either 
determined to be suitable for transplantation or appropriate disposition 
is accomplished.
    (f) All persons or establishments that generate records used in 
determining the suitability of the donor shall retain such records and 
make them available for authorized inspection or upon request by FDA. 
The person(s) or establishment(s) making the determination regarding the 
suitability of the donor shall retain all records, or true copies of 
such records required under Sec. 1270.21, including all testing and 
screening records, and shall make them available for authorized 
inspection or upon request from FDA. Records that can be retrieved from 
another location by electronic means meet the requirements of this 
paragraph.
    (g) Records required under this part may be retained electronically, 
or as original paper records, or as true copies such as photocopies, 
microfiche, or microfilm, in which case suitable reader and photocopying 
equipment shall be readily available.
    (h) Records shall be retained at least 10 years beyond the date of 
transplantation if known, distribution, disposition, or expiration, of 
the tissue, whichever is latest.

[62 FR 40444, July 29, 1997, as amended at 63 FR 16685, Apr. 6, 1998]