[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.41]

[Page 80]
 
                        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 
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.

[66 FR 31164, June 11, 2001]