[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.45]

[Page 74]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
                    Subpart E--Hepatitis Requirements
 
Sec. 610.45  Human Immunodeficiency Virus (HIV) requirements.

    (a) Testing requirements. (1) Each donation of human blood or blood 
components intended for use in preparing a product shall be tested for 
antibody to HIV by a test approved for such use by FDA, except as 
otherwise approved in writing by FDA. When the test for antibody to HIV 
is required, blood and blood products may be issued before the results 
of the test for antibody to HIV are available only in dire emergency 
situations or as otherwise approved in writing by FDA and, provided the 
test required by this paragraph is performed as soon as possible after 
issuance of the blood or blood product.
    (2) Tests approved by FDA for the screening of blood and blood 
components for evidence of HIV may only be used in place of a test for 
antibody to HIV to satisfy the requirements of this section and related 
sections if so specified by FDA.
    (b) Testing responsibility. The test for antibody to HIV shall be 
performed by the collection facility, by personnel of an establishment 
licensed to manufacture blood or blood derivatives under section 351(a) 
of the Public Health Service Act (42 U.S.C. 262(a)), or by a clinical 
laboratory which meets the standards of the Clinical Laboratory 
Improvement Act of 1967 (CLIA) (42 U.S.C. 263a), provided the 
establishment or clinical laboratory is qualified to perform the test.
    (c) Restrictions on use. (1) Blood, plasma, or other blood 
components that are repeatably reactive to a test for antibody to HIV or 
that were collected from a donor whose blood is known to be repeatably 
reactive to a test for antibody to HIV, shall not be shipped or used to 
prepare any product, including products not subject to licensure; except 
that such blood and blood components shall be shipped or used only for 
purposes and under conditions specifically approved in writing by FDA.
    (2) The restrictions on use contained in this paragraph shall not 
apply in the following cases:
    (i) Blood and blood components testing repeatably reactive or from a 
donor whose blood is known to be repeatably reactive that are shown to 
be negative for evidence of HIV infection by a method or process 
approved for such use by FDA;
    (ii) The distribution of blood, plasma, or serum samples, except 
when intended for use in the manufacture of a product;
    (iii) The in-house use of blood and blood components for research 
purposes; or
    (iv) The distribution of blood and blood components for research 
purposes, if not distributed by sale, barter, or exchange.
    (d) For a donor whose test results for antibody to HIV are 
repeatedly reactive or otherwise determined to be unsuitable when tested 
in accordance with paragraph (a) of this section, the blood 
establishment shall comply, as applicable, with Secs. 610.46 and 610.47.

[53 FR 116, Jan. 5, 1988, as amended at 61 FR 47423, Sept. 9, 1996]