---
kind: "section"
citation: "21 C.F.R. § 610.41"
title: "21"
number: "610.41"
heading: "Donor deferral."
url: "https://uscodex.org/cfr/21/610.41"
---

# §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 relevant transfusion-transmitted infection(s) under [§ 610.40(a)](/cfr/21/610.40.md?p=a), 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 and II, on only one occasion. However, you must defer the donor if further testing for HBV or HTLV has been performed under [§ 610.40(e)](/cfr/21/610.40.md?p=e) and the donor is found to be positive, or if a second, licensed, cleared, or approved screening test for HBV or HTLV has been performed on the same donation under [§ 610.40(a)](/cfr/21/610.40.md?p=a) and is reactive, or if the donor tests reactive for anti-HBc or anti-HTLV, types I and II, on more than one occasion;
  - (2) A deferred donor who tests reactive for evidence of infection due to a relevant transfusion-transmitted infection(s) under [§ 610.40(a)](/cfr/21/610.40.md?p=a) may serve as a donor for blood or blood components shipped or used under [§ 610.40(h)(2)(ii)](/cfr/21/610.40.md?p=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)](/cfr/21/610.40.md?p=a), [(b)](/cfr/21/610.40.md?p=b), and [(e)](/cfr/21/610.40.md?p=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 eligible;
  - (4) A deferred donor, who otherwise is determined to be eligible 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 relevant transfusion-transmitted infections(s) under [§ 610.40(a)](/cfr/21/610.40.md?p=a), may serve as an autologous donor under [§ 610.40(d)](/cfr/21/610.40.md?p=d).
- (b) A deferred donor subsequently may be found to be eligible 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](/cfr/21/610.46.md) and [610.47](/cfr/21/610.47.md) when a donor tests reactive by a screening test for HIV or HCV required under § [610.40(a)](/cfr/21/610.40.md?p=a) and [(b)](/cfr/21/610.40.md?p=b), or when you are aware of other reliable test results or information indicating evidence of HIV or HCV infection.

## Notes

### Amendments

[66 FR 31164, June 11, 2001, as amended at 72 FR 48798, Aug. 24, 2007; 80 FR 29897, May 22, 2015]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.

### Source

Source: 38 FR 32056, Nov. 20, 1973, unless otherwise noted.

### Amendments

[66 FR 31164, June 11, 2001, as amended at 72 FR 48798, Aug. 24, 2007; 80 FR 29897, May 22, 2015]