StacksVerified U.S. regulatory reference

21 CFR §640.103

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.