[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: 21CFR640.104]

[Page 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. 640.104  Potency.

    (a) Antibody levels and tests. Each lot of final product shall 
contain at least the minimum levels of antibodies for diphtheria, 
measles, and for at least one type of poliomyelitis. In the event the 
final bulk solution is stored at a temperature above 5  deg.C the 
antibody level tests shall be performed after such storage with a sample 
of the stored material.
    (b) Minimum levels. The minimum antibody levels are as follows:
    (1) No less than 2 units of diphtheria antitoxin per ml.
     (2) A measles neutralizing antibody level that, when compared with 
that of a reference material designated by the Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, as 
indicated in paragraph (c) of this section, demonstrates adequate 
potency. The Director, CBER, shall notify manufacturers when a new 
reference material will be used and will advise manufacturers of an 
appropriate antibody level taking into account a comparison of the new 
reference material to the previous reference material.
    (3) A poliomyelitis Type 1, Type 2, or Type 3 neutralizing antibody 
level that, when compared with that of a reference material designated 
by the Center for Biologics Evaluation and Research, Food and Drug 
Administration, as indicated in paragraph (c) of this section, 
demonstrates adequate potency. The Director, CBER, shall notify 
manufacturers when a new reference material will be used and will advise 
manufacturers of an appropriate antibody level taking into account a 
comparison of the new reference material to the previous reference 
material.
    (c) Reference materials. The following reference materials shall be 
obtained from the Center for Biologics Evaluation and Research:
     (1) Reference Immune Globulin for correlation of measles antibody 
titers.
     (2) Reference Immune Globulin for correlation of poliomyelitis 
antibody titers, Types 1, 2, and 3.

[38 FR 32089, Nov. 20, 1973, as amended at 39 FR 9661, Mar. 13, 1974; 49 
FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 55 FR 11013, Mar. 26, 
1990; 63 FR 16685, Apr. 6, 1998; 64 FR 26287, May 14, 1999]

Subpart K  [Reserved]