Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 610  /  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]