21 C.F.R. § 610.41 Donor deferral.
Title 21 - Food and Drugs
(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. [66 FR 31164, June 11, 2001]
Title 21: Food and Drugs
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
Subpart E—Testing Requirements for Communicable Disease Agents
§ 610.41 Donor deferral.
