Code of Federal Regulations · Section
§ 630.25 — Exceptions From Certain Donor Eligibility Requirements For Infrequent Plasma Donors
21 C.F.R. § 630.25
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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.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321
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Regulations42 U.S.C. § 216