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BCG Vaccine
» 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 var. bovis, 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.
NOTE—Use the Vaccine immediately after its constitution, and discard any unused portion after 2 hours.
Packaging and storage— Preserve in hermetic containers, preferably of Type I glass, at a temperature between 2 and 8.
Expiration date— The expiration date is not later than 6 months after date of issue, or not later than 1 year after date of issue if stored at a temperature below 5.
Auxiliary Information— Staff Liaison : Tina S. Morris, Ph.D., Senior Scientist
Expert Committee : (BBVV05) Biologics and Biotechnology - Vaccines and Virology
USP29–NF24 Page 242
Phone Number : 1-301-816-8397