TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER F - BIOLOGICS

PART 640 - ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

subpart j - IMMUNE GLOBULIN (HUMAN)

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 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]