21 CFR 630.25 - Exceptions from certain donor eligibility requirements for infrequent plasma donors.

Regulations last checked for updates: May 07, 2024

Title 21 - Food and Drugs last revised: Apr 29, 2024

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

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.

authority: 21 U.S.C. 321,331,351,352,355,360,371; 42 U.S.C. 216,262,264

source: 66 FR 31176, June 11, 2001, unless otherwise noted.

cite as: 21 CFR 630.25