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21 U.S.C. 321, 331, 351, 352, 355, 360, 371; 42 U.S.C. 216, 262, 264.
66 FR 31176, June 11, 2001, unless otherwise noted.
80 FR 29898, May 22, 2015, unless otherwise noted.
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(a) What is the purpose of subparts A, B, and C of this part ? The purpose of these subparts, together with §§ 610.40 and 610.41 of this chapter, is to provide certain minimum criteria for each donation of blood and blood components, for:
(1) Determining the eligibility of a donor of blood and blood components;
(2) Determining the suitability of the donation of blood and blood components; and
(3) Notifying a donor who is deferred from donation.
(b) Who must comply with subparts A, B, and C of this part ? Blood establishments that manufacture blood and blood components, as defined in § 630.3(a) and (b), must comply with subparts A, B, and C of this part.