21 C.F.R. § 630.25
Exceptions from certain donor eligibility requirements for infrequent plasma donors.
Cite as 21 C.F.R. § 630.25 (2026)
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.
- Cross-references to the CFR
- 630.15640.65