BCG Vaccine
»BCG Vaccine conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a dried,living culture of the bacillus Calmette-Guérin strain of Mycobacterium tuberculosisvar.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 2hours.
Packaging and storage— Preserve in hermetic containers,preferably of Type Iglass,at a temperature between 2and 8.
Expiration date— The expiration date is not later than 6months after date of issue,or not later than 1year after date of issue if stored at a temperature below 5.
Auxiliary Information— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 222
Phone Number:1-301-816-8397
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