[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.46]

[Page 81-83]
 
                        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  Human immunodeficiency virus (HIV) ``lookback'' requirements.

    (a) If you are an establishment that collects Whole Blood or blood 
components, including Source Plasma and Source Leukocytes, you must 
establish, maintain, and follow an appropriate system for the following 
actions:
    (1) Within 3 calendar days after a donor tests reactive for evidence 
of human immunodeficiency virus (HIV) infection when tested under Sec. 
610.40(a) and (b) or when you are made aware of other reliable test 
results or information indicating evidence of HIV infection, you must 
review all records required under Sec. 606.160(d) of this chapter, to 
identify blood and blood components previously donated by such a donor. 
For those identified blood and blood components collected:
    (i) Twelve months and less before the donor's most recent 
nonreactive screening tests, or
    (ii) Twelve months and less before the donor's reactive direct viral 
detection test, e.g., nucleic acid test or HIV

[[Page 82]]

p24 antigen test, and nonreactive antibody screening test, whichever is 
the lesser period, you must:
    (A) Quarantine all previously collected in-date blood and blood 
components identified under paragraph (a)(1) of this section if intended 
for use in another person or for further manufacture into injectable 
products, except pooled blood components intended solely for further 
manufacturing into products that are manufactured using validated viral 
clearance procedures; and
    (B) Notify consignees to quarantine all previously collected in-date 
blood and blood components identified under paragraph (a)(1) of this 
section if intended for use in another person or for further manufacture 
into injectable products, except pooled blood components intended solely 
for further manufacturing into products that are manufactured using 
validated viral clearance procedures;
    (2) You must perform a supplemental (additional, more specific) test 
for HIV as required under Sec. 610.40(e) of this chapter on the 
reactive donation.
    (3) You must notify consignees of the supplemental (additional, more 
specific) test results for HIV, or the results of the reactive screening 
test if there is no available supplemental test that is approved for 
such use by FDA, or if under an investigational new drug application 
(IND) or investigational device exemption (IDE), is exempted for such 
use by FDA, within 45 calendar days after the donor tests reactive for 
evidence of HIV infection under Sec. 610.40(a) and (b) of this chapter. 
Notification of consignees must include the test results for blood and 
blood components identified under paragraph (a)(1) of this section that 
were previously collected from donors who later test reactive for 
evidence of HIV infection.
    (4) You must release from quarantine, destroy, or relabel 
quarantined in-date blood and blood components, consistent with the 
results of the supplemental (additional, more specific) test performed 
under paragraph (a)(2) of this section or the results of the reactive 
screening test if there is no available supplemental test that is 
approved for such use by FDA, or if under an IND or IDE, exempted for 
such use by FDA.
    (b) If you are a consignee of Whole Blood or blood components, 
including Source Plasma and Source Leukocytes, you must establish, 
maintain, and follow an appropriate system for the following actions:
    (1) You must quarantine all previously collected in-date blood and 
blood components identified under paragraph (a)(1) of this section, 
except pooled blood components intended solely for further manufacturing 
into products that are manufactured using validated viral clearance 
procedures, when notified by the collecting establishment.
    (2) You must release from quarantine, destroy, or relabel 
quarantined in-date blood and blood components consistent with the 
results of the supplemental (additional, more specific) test performed 
under paragraph (a)(2) of this section, or the results of the reactive 
screening test if there is no available supplemental test that is 
approved for such use by FDA, or if under an IND or IDE, is exempted for 
such use by FDA.
    (3) When the supplemental (additional, more specific) test for HIV 
is positive or when the screening test is reactive and there is no 
available supplemental test that is approved for such use by FDA, or if 
under an IND or IDE is exempted for such use by FDA, you must notify 
transfusion recipients of previous collections of blood and blood 
components at increased risk of transmitting HIV infection, or the 
recipient's physician of record, of the need for recipient HIV testing 
and counseling. You must notify the recipient's physician of record or a 
legal representative or relative if the recipient is a minor, deceased, 
adjudged incompetent by a State court, or, if the recipient is competent 
but State law permits a legal representative or relative to receive 
information on behalf of the recipient. You must make reasonable 
attempts to perform the notification within 12 weeks after receiving the 
supplemental (additional, more specific) test results for evidence of 
HIV infection from the collecting establishment, or after receiving the 
donor's reactive screening test result for HIV if there is no available 
supplemental test that is approved for such use by FDA, or if

[[Page 83]]

under an IND or IDE is exempted for such use by FDA.
    (c) Actions under this section do not constitute a recall as defined 
in Sec. 7.3 of this chapter.

[72 FR 48799, Aug. 24, 2007]