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 J—Immune Globulin (Human)

21 C.F.R. § 640.103

The final product

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(a) Final solution. The final product shall be a 16.5 ±1.5 percent solution of globulin containing 0.3 molar glycine and a preservative.

(b) Protein composition. At least 96 percent of the total protein shall be immunoglobulin G (IgG), as determined by a method that has been approved for each manufacturer by the Director, Center for Biologics Evaluation and Research, Food and Drug Administration.

[38 FR 32089, Nov. 20, 1973, as amended at 64 FR 26287, May 14, 1999]
Notes of Decisions
Cited in 2 cases, 2007–2008 · leading case: Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007).
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Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007). · cites it 4× “See 21 C.F.R. § 640.103 (a) (“The final product shall be a 16.”
Sykes v. Bayer Pharm. Corp., 548 F. Supp. 2d 208 (E.D. Va. 2008). “” 21 C.F.R. § 640.103 (a) (emphasis added).”
— 21 C.F.R. § 640.103(a) — 1 case
Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007). “See 21 C.F.R. § 640.103 (a) (“The final product shall be a 16.”
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