21 CFR Part 630 · Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use

§ 630.1 Purpose and scope

Subpart A - General Provisions Official text on eCFR Amendment history

(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 .

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Amendment history

Federal Register documents that created or amended this section.