21 CFR § 640.103 - The final product.

---
identifier: "/us/cfr/t21/s640.103"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 640.103 - The final product."
title_number: 21
title_name: "Food and Drugs"
section_number: "640.103"
section_name: "The final product."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "640"
part_name: "ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264."
regulatory_source: "38 FR 32089, Nov. 20, 1973, unless otherwise noted."
cfr_part: "640"
---


# 640.103 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.

[38 FR 32089, Nov. 20, 1973, as amended at 64 FR 26287, May 14, 1999]