21 CFR Part 630 · Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use

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

Subpart B - Donor Eligibility Requirements Official text on eCFR Amendment history

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 .

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Amendment history

Federal Register documents that created or amended this section.