[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.103]

[Page 106-107]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                   Subpart J--Immune Globulin (Human)
 
Sec. 640.103  The final product.

    (a) Final solution. The final product shall be a 
16.5plus-minus1.5 percent solution of

[[Page 107]]

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]