21 C.F.R. § 610.41

Donor deferral

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(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), 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) 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) 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) 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 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), may serve as an autologous donor under § 610.40(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 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.

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

Notes of Decisions

Cited in 6 cases (3 in the last 5 years), 1985–2025 · leading case: Hillsborough Cnty. v. Automated Med. Labs., Inc., 471 U.S. 707 (1985).

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Hillsborough Cnty. v. Automated Med. Labs., Inc., 471 U.S. 707 (1985). “21 CFR § 610.41 (1984). To the extent that the Hillsborough County ordinances preclude individuals with hepatitis from donating their plasma, the ordinances are said to stand in the way of the accomplishment of the federal goal of combating hepatitis.”

Doe v. Am. Red Cross Blood Servs., S.C. Region, 125 F.R.D. 646 (D.S.C. 1989). · cites it 2× “See 21 C.F.R. § 610.41 . . Plaintiffs sought the identity of the donor by way of interrogatory.”

Matheis v. CSL Plasma, Inc., 346 F. Supp. 3d 723 (M.D. Penn. 2018). · cites it 2× “For instance, CSL must screen potential donors for HIV and other infectious diseases and defer donors that test positive for certain disease indicators even though HIV-infection has been held to be a disability under the ADA.”

Trinidad v. BioLife Plasma Servs. LLC (D. Ariz. 2021). · cites it 2× “21 C.F.R. § 610.41 (a) (2016). 25 On July 23, 2020, Plaintiff visited Defendant’s Tempe facility but was informed she 26 would not be able to donate because of “an unspecified issue relating to her blood test 27 1 Defendant’s request for oral argument is denied because the…”

Anderson v. Octapharma Plasma Inc. (N.D. Tex. 2021). “41(b) of this chapter,” and 21 C.F.R. § 610.41 (b), which provides that “[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 [the Food and Drug…”

Lambert v. Octapharma Plasma, Inc. (E.D. Tex. 2025). “And because 21 C.F.R. § 610.41 (a) requires plasma collection centers like Octapharma to report reactive tests to the Registry, this harm is directly linked to the centers’ behavior.”

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