[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 728-729]
 
                        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 C_Donor Eligibility
 
Sec.  1271.55  What records must accompany an HCT/P after the 
donor-eligibility determination is complete; and what records must 
I retain?

    (a) Accompanying records. Once a donor-eligibility determination has 
been made, the following must accompany the HCT/P at all times:
    (1) A distinct identification code affixed to the HCT/P container, 
e.g., alphanumeric, that relates the HCT/P to the donor and to all 
records pertaining to the HCT/P and, except in the case of autologous 
donations, directed reproductive donations, or donations made by first-
degree or second-degree blood relatives, does not include an 
individual's name, social security number, or medical record number;
    (2) A statement whether, based on the results of screening and 
testing, the donor has been determined to be eligible or ineligible; and
    (3) A summary of the records used to make the donor-eligibility 
determination.
    (b) Summary of records. The summary of records required by paragraph 
(a)(3)

[[Page 729]]

of this section must contain the following information:
    (1) A statement that the communicable disease testing was performed 
by a laboratory:
    (i) Certified to perform such testing on human specimens under the 
Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 
42 CFR part 493; or
    (ii) That has met equivalent requirements as determined by the 
Centers for Medicare and Medicaid Services in accordance with those 
provisions;
    (2) A listing and interpretation of the results of all communicable 
disease tests performed;
    (3) The name and address of the establishment that made the donor-
eligibility determination; and
    (4) In the case of an HCT/P from a donor who is ineligible based on 
screening and released under paragraph (b) of Sec.  1271.65, a statement 
noting the reason(s) for the determination of ineligibility.
    (c) Deletion of personal information. The accompanying records 
required by this section must not contain the donor's name or other 
personal information that might identify the donor.
    (d) Record retention requirements. (1) You must maintain 
documentation of:
    (i) Results and interpretation of all testing for relevant 
communicable disease agents in compliance with Sec. Sec.  1271.80 and 
1271.85, as well as the name and address of the testing laboratory or 
laboratories;
    (ii) Results and interpretation of all donor screening for 
communicable diseases in compliance with Sec.  1271.75; and
    (iii) The donor-eligibility determination, including the name of the 
responsible person who made the determination and the date of the 
determination.
    (2) All records must be accurate, indelible, and legible. 
Information on the identity and relevant medical records of the donor, 
as defined in Sec.  1271.3(s), must be in English or, if in another 
language, must be retained and translated to English and accompanied by 
a statement of authenticity by the translator that specifically 
identifies the translated document.
    (3) You must retain required records and make them available for 
authorized inspection by or upon request from FDA. Records that can be 
readily retrieved from another location by electronic means are 
considered ``retained.''
    (4) You must retain the records pertaining to a particular HCT/P at 
least 10 years after the date of its administration, or if the date of 
administration is not known, then at least 10 years after the date of 
the HCT/P's distribution, disposition, or expiration, whichever is 
latest.

[69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005]