Botulism Antitoxin
»Botulism Antitoxin conforms to the regulations of the federal Food and Drug Administration concerning biologics (see Biologics á1041ñ).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 Aand type Band/or type Estrains 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 20.0percent of solids,and contains a suitable antimicrobial agent.
Packaging and storage— Preserve in single-dose containers only,at a temperature between 2and 8.
Expiration date— The expiration date for Antitoxin containing a 20%excess of potency is not later than 5years after date of issue from manufacturer's cold storage (5,1year;or 0,2years).
Labeling— Label it to state that it was prepared from horse blood.
Auxiliary Information— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 279
Phone Number:1-301-816-8397