» BCG Vaccine conforms to the regulations of the FDA concerning biologics (see Biologics 1041
). It is a dried, living culture of the bacillus Calmette-Guérin strain of Mycobacterium tuberculosis
, grown in a suitable medium from a seed strain of known history that has been maintained to preserve its capacity for conferring immunity. It contains an amount of viable bacteria such that inoculation, in the recommended dose, of tuberculin-negative persons results in an acceptable tuberculin conversion rate. It is free from other organisms, and contains a suitable stabilizer. It contains no antimicrobial agent.