[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.46]

[Page 78-79]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
     Subpart E--Testing Requirements for Communicable Disease Agents
 
Sec. 610.46  ``Lookback'' requirements.

    (a) Quarantine and notification. (1) All blood and plasma 
establishments are required to take appropriate action when a donor of 
Whole Blood, blood components, Source Plasma and Source Leukocytes tests 
repeatedly reactive for antibody to human immunodeficiency virus (HIV), 
or otherwise is determined to be unsuitable when tested in accordance 
with Sec. 610.45. For Whole Blood, blood components, Source Plasma and 
Source Leukocytes collected from that donor within the 5 years prior to 
the repeatedly reactive test, if intended for transfusion, or collected 
within the 6 months prior to the repeatedly reactive test, if intended 
for further manufacture into injectable products, except those products 
exempt from quarantine in accordance with Sec. 610.46(c), the blood 
establishment shall promptly, within 72 hours:
    (i) Quarantine all such Whole Blood, blood components, Source Plasma 
and Source Leukocytes from previous collections held at that 
establishment; and
    (ii) Notify consignees of the repeatedly reactive HIV screening test 
results so that all Whole Blood, blood components, Source Plasma and 
Source Leukocytes from previous collections they hold are quarantined.
    (2) Consignees notified in accordance with paragraph (a)(1)(ii) of 
this section shall quarantine Whole Blood, blood components, Source 
Plasma and Source Leukocytes held at that establishment except as 
provided in paragraph (c) of this section.
    (b) Further testing and notification of consignees of results. Blood 
establishments that have collected Whole Blood, blood components, Source 
Plasma or Source Leukocytes from a donor as described in paragraph (a) 
of this section shall perform a licensed, more specific test for HIV on 
the donor's blood, and in the case of distributed products, further 
shall notify the consignee(s) of the results of this test, within 30 
calendar days after the donor's repeatedly reactive test. Pending the 
availability of a licensed, more specific test for HIV-2, a second, 
different screening test for antibody to HIV-2 shall be used along with 
a licensed, more specific test for HIV-1.

[[Page 79]]

    (c) Exemption from quarantine. Products intended for transfusion 
need not be held in quarantine if a determination has been made that the 
Whole Blood, blood components, Source Plasma or Source Leukocytes was 
collected more than 12 months prior to the donor's most recent negative 
antibody screening test when tested in accordance with Sec. 610.45. 
Pooled Source Plasma and Source Leukocytes are exempt from quarantine.
    (d) Release from quarantine. Whole Blood, blood components, Source 
Plasma and Source Leukocytes intended for transfusion or further 
manufacture which have been quarantined under paragraph (a) of this 
section may be released if the donor is subsequently tested for antibody 
to HIV as provided in paragraph (b) of this section and the test result 
is negative, absent other informative test results.
    (e) Actions under this section do not constitute a product recall as 
defined in Sec. 7.3(g) of this chapter.

[61 FR 47423, Sept. 9, 1996]