StacksVerified U.S. regulatory reference

21 CFR §630.25

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
For an infrequent plasma donor who is not participating in an immunization program, establishments are not required to:
  1. (a)Perform a medical history and physical examination of the donor under § 630.15(b)(1);
  2. (b)Perform a test for total protein under § 630.15(b)(4);
  3. (c)Determine the total plasma or serum protein and immunoglobulin composition under § 640.65(b)(1)(i) of this chapter; or
  4. (d)Review the data and records as required in § 640.65(b)(2)(i) of this chapter.