C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER F—BIOLOGICS › PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS › Subpart G—Source Plasma

21 C.F.R. § 640.60

Source Plasma

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The proper name of the product shall be Source Plasma. The product is defined as the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use. The definition excludes single donor plasma products intended for intravenous use.

[41 FR 10768, Mar. 12, 1976, as amended at 50 FR 4140, Jan. 29, 1985]
Notes of Decisions
Cited in 2 cases, 1982–2015 · leading case: United States v. Pedro M. Diaz & Susana Diaz, 690 F.2d 1352 (11th Cir. 1982).
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United States v. Pedro M. Diaz & Susana Diaz, 690 F.2d 1352 (11th Cir. 1982). “” 21 C.F.R. § 640.60 (1982). This expanded definition is important here because the PTS produced by defendants is not used in the manufacture of injectable products.”
Scott v. CSL Plasma, Inc., 151 F. Supp. 3d 961 (D. Minnesota 2015). “21 C.F.R. § 640.60 . Section 525A.25 therefore does not apply.”
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