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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 B - Donor Eligibility Requirements |
§ 630.25 - Exceptions from certain donor eligibility requirements for infrequent plasma donors.
Latest version.
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§ 630.25 Exceptions from certain donor eligibility requirements for infrequent plasma donors.
For an infrequent plasma donor who is not participating in an immunization program, establishments are not required to:
(a) Perform a medical history and physical examination of the donor under § 630.15(b)(1);
(b) Perform a test for total protein under § 630.15(b)(4);
(c) Determine the total plasma or serum protein and immunoglobulin composition under § 640.65(b)(1)(i) of this chapter; or
(d) Review the data and records as required in § 640.65(b)(2)(i) of this chapter.