21 CFR § 630.25
Exceptions from certain donor eligibility requirements for infrequent plasma donors
June 25, 2020
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.