» Botulism Antitoxin conforms to the regulations of the federal Food and Drug Administration concerning biologics (see
Biologics 1041). It is a sterile, nonpyrogenic solution of the refined and concentrated antitoxic antibodies, chiefly globulins, obtained from the blood of healthy horses that have been immunized against the toxins produced by the type A and type B and/or type E strains of
Clostridium botulinum. Its potency is determined with the U.S. Standard Botulism Antitoxin of the relevant type, tested by neutralizing activity in mice of the corresponding U.S. Control Botulism Test Toxin. It contains not more than 20.0 percent of solids, and contains a suitable antimicrobial agent.