HHS - 21 CFR PART 630
REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE
| Organization: | HHS |
| Publication Date: | 1 April 2023 |
| Status: | active |
| Page Count: | 11 |
scope:
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.
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