21 C.F.R. § 610.21 Limits of potency.
Title 21 - Food and Drugs
Link to an amendment published at 70 FR 75028, Dec. 19, 2005. 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), 50 units of tetanus antitoxin per milliliter. 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]
Title 21: Food and Drugs
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
Subpart C—Standard Preparations and Limits of Potency
§ 610.21 Limits of potency.
