21 CFR 640.103 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 600.2 To Parts 741-799) — Food And Drug Administration, Department Of Health And Human Services (Continued) (§ 600.2 To Parts 741-799) — Biologics (§ 600.2 To § 680.3) — Additional Standards For Human Blood And Blood Products (§ 640.1 To § 640.130) — Immune Globulin (Human) (§ 640.100 To § 640.104) — The final product.

(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.