21 C.F.R. § 630.1 – Purpose and scope.

(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. (1) Determining the eligibility of a donor of blood and blood components;
2. (2) Determining the suitability of the donation of blood and blood components; and
3. (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.