GroundRules
21 CFR 630.25: Exceptions from certain donor eligibility requirements for infrequent plasma donors.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER F—BIOLOGICS
- PART 630—REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE
- Subpart B—Donor Eligibility Requirements
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON