[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: 21CFR610.41]

[Page 80-81]
 
                        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. 610.41  Donor deferral.

    (a) You, an establishment that collects human blood or blood 
components, must defer donors testing reactive by a screening test for 
evidence of infection due to a communicable disease agent(s) listed in 
Sec. 610.40(a) or reactive for a serological test for syphilis under 
Sec. 610.40(i), from future donations of human blood and blood 
components, except:
    (1) You are not required to defer a donor who tests reactive for 
anti-HBc or anti-HTLV, types I or II, on only one occasion. When a 
supplemental (additional, more specific) test for anti-HBc or anti-HTLV, 
types I and II, has been approved for use under Sec. 610.40(e) by FDA, 
such a donor must be deferred;
    (2) A deferred donor who tests reactive for evidence of infection 
due to a communicable disease agent(s) listed in Sec. 610.40(a) may 
serve as a donor for blood or blood components shipped or used under 
Sec. 610.40(h)(2)(ii);
    (3) A deferred donor who showed evidence of infection due to 
hepatitis B surface antigen (HBsAg) when previously tested under Sec. 
610.40(a), (b), and (e) subsequently may donate Source Plasma for use in 
the preparation of Hepatitis B Immune Globulin (Human) provided the 
current donation tests nonreactive for HBsAg and the donor is otherwise 
determined to be suitable;
    (4) A deferred donor, who otherwise is determined to be suitable for 
donation and tests reactive for anti-HBc or for evidence of infection 
due to HTLV, types I and II, may serve as a donor of Source Plasma;
    (5) A deferred donor who tests reactive for a communicable disease

[[Page 81]]

agent(s) described under Sec. 610.40(a) or reactive with a serological 
test for syphilis under Sec. 610.40(i), may serve as an autologous 
donor under Sec. 610.40(d).
    (b) A deferred donor subsequently may be found to be suitable as a 
donor of blood or blood components by a requalification method or 
process found acceptable for such purposes by FDA. Such a donor is 
considered no longer deferred.
    (c) You must comply with the requirements under Sec. Sec. 610.46 
and 610.47 when a donor tests reactive by a screening test for HIV or 
HCV required under Sec. 610.40(a) and (b), or when you are aware of 
other reliable test results or information indicating evidence of HIV or 
HCV infection.

[66 FR 31164, June 11, 2001, as amended at 72 FR 48798, Aug. 24, 2007]