[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.21]

[Page 76]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610_GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
          Subpart C_Standard Preparations and Limits of Potency
 
Sec.  610.21  Limits of potency.

    The potency of the following products shall be not less than that 
set forth below and products dispensed in the dried state shall 
represent liquid products having the stated limitations.

                               Antibodies

Diphtheria Antitoxin, 500 units per milliliter.
Tetanus Antitoxin, 400 units per milliliter.
Tetanus Immune Globulin (Human), 250 units of tetanus antitoxin per 
container.

                                Antigens

Cholera Vaccine, 8 units each of Inaba and Ogawa serotype antigens per 
milliliter.
Pertussis Vaccine, 12 units per total human immunizing dose.
Typhoid Vaccine, 8 units per milliliter.

[41 FR 10429, Mar. 11, 1976, as amended at 41 FR 18295, May 3, 1976; 70 
FR 75028, Dec. 19, 2005]