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

21 C.F.R. § 630.25

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.

Notes, amendments, and revision history

Source: 80 FR 29898, May 22, 2015, unless otherwise noted.

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.