[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: 21CFR640.101]

[Page 106]
 
                        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. 640.101  General requirements.

    (a) Heat stability test. Approximately 2 ml. of completely processed 
material of each lot shall not show any visible sign of gelation after 
heating in a 12 x 75 mm. stoppered glass tube at 57  deg.C for 4 hours.
    (b) pH. The pH of final container material shall be 
6.8plus-minus0.4 when measured in a solution diluted to 1 
percent protein with 0.15 molar sodium chloride.
    (c) Turbidity. The product shall be free of turbidity as determined 
by visual inspection of final containers.
    (d) Date of manufacture. The date of manufacture is the date of 
initiating the last valid measles or poliomyelitis antibody test 
(Sec. 640.104(b) (2) and (3)) whichever date is earlier.
    (e) Labeling. In addition to complying with all applicable labeling 
required in this subchapter, labeling shall indicate that:
    (1) There is no prescribed potency for viral hepatitis antibodies.
    (2) The product is not recommended for intravenous administration.

[38 FR 32089, Nov. 20, 1973; 48 FR 13026, Mar. 29, 1983, as amended at 
49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 51 FR 15611, Apr. 
25, 1986; 55 FR 11013, Mar. 26, 1990; 63 FR 16685, Apr. 6, 1998; 64 FR 
26287, May 14, 1999]