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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter F - Biologics |
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Part 630 - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use |
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Subpart A - General Provisions |
§ 630.1 - Purpose and scope.
Latest version.
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§ 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) 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.