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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter FPart 630Subpart B → §630.25


Title 21: Food and Drugs
PART 630—REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE
Subpart B—Donor Eligibility Requirements


§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.

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