Coccidioidin
»Coccidioidin conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a sterile solution containing the antigens obtained from the by-products of mycelial growth or from the spherules of the fungus Coccidioides immitis.It has a potency such that the 1:100dilution is bioequivalent to the U.S.Reference Coccidioidin 1:100.It contains a suitable antimicrobial agent.
Packaging and storage—
Preserve at a temperature between 2
and 8.
and 8.
Expiration date—
The expiration date is not later than 3years after date of issue from manufacturer's cold storage (5,1year)for the mycelial product and not later than 18months after date of issue from manufacturer's cold storage (5,18months)for the spherule-derived product.
,1year)for the mycelial product and not later than 18months after date of issue from manufacturer's cold storage (5,18months)for the spherule-derived product.
Labeling—
Label it to state that any dilutions made of the product should be stored in a refrigerator and used within 24hours.Label it also to state that a separate syringe and needle shall be used for each individual injection.
Auxiliary Information—
Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 533
Phone Number:1-301-816-8385