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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2015]
[CITE: 21CFR610.41]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F--BIOLOGICS

PART 610 -- GENERAL BIOLOGICAL PRODUCTS STANDARDS

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 610.40(a) or reactive for a serological test for syphilis under 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 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 610.40(a) may serve as a donor for blood or blood components shipped or used under 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 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 610.40(a) or reactive with a serological test for syphilis under 610.40(i), may serve as an autologous donor under 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 610.46 and 610.47 when a donor tests reactive by a screening test for HIV or HCV required under 610.40(a) and (b), or when you are aware of other reliable test results or information indicating evidence of HIV or HCV infection.

Link to an amendment published at 80 FR 29897, May 22, 2015.

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

The information on this page is current as of April 1 2015.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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