|
|
1041
). It is a sterile solution derived from the concentrated, soluble products of growth of the tubercle bacillus (Mycobacterium tuberculosis or Mycobacterium bovis) prepared in a special medium. It is provided either as Old Tuberculin, a culture filtrate adjusted to the standard potency based on the U.S. Standard Tuberculin, Old, by addition of glycerin and isotonic sodium chloride solution, or as Purified Protein Derivative (PPD), a further purified protein fraction standardized with the U.S. Standard Tuberculin, Purified Protein Derivative. It has a potency, tested by comparison with the corresponding U.S. Standard Tuberculin, on intradermal injection of sensitized guinea pigs, of between 80 percent and 120 percent of that stated on the label. It is free from viable Mycobacteria as shown by injection into guinea pigs.
and 8. Multiple-puncture devices may be stored at a temperature not exceeding 30.
, 1 year; or 0, 2 years). The expiration date of diluted Old Tuberculin is not later than 1 year after date of issue from manufacturer's cold storage (5, 1 year; or 0, 2 years). The expiration date of concentrated PPD containing 50% of glycerin is not later than 2 years after date of issue from manufacturer's cold storage (5, 1 year). The expiration date of diluted PPD is not later than 1 year after date of issue by the manufacturer. The expiration date of Old Tuberculin and PPD dried on multiple-puncture devices is not later than 2 years after date of issue from manufacturer's cold storage (30, 1 year), provided the recommended storage is at a temperature not exceeding 30.