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21 CFR 630.25

§ 630.25 Exceptions from certain donor eligibility requirements for infrequent plasma donors.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 630.25, § 630.25 Exceptions from certain donor eligibility requirements for infrequent plasma donors, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88455
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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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.