Immune Globulin
»Immune Globulin conforms to the regulations of the FDAconcerning biologics (640.100to 640.104)(see Biologics á1041ñ).It is a sterile,nonpyrogenic solution of globulins that contains many antibodies normally present in adult human blood,prepared by pooling approximately equal amounts of material (source blood,plasma,serum,or placentas)from not less than 1000donors.It contains not less than 15g and not more than 18g of protein per 100mL,not less than 90.0percent of which is gamma globulin.It contains 0.3Mglycine as a stabilizing agent and contains a suitable preservative.It has a potency of component antibodies of diphtheria antitoxin based on the U.S.Standard Diphtheria Antitoxin and a diphtheria test toxin,tested in guinea pigs (not less than 2antitoxin units per mL),and antibodies for measles and poliovirus.It meets the requirements of the tests for heat stability in absence of gelation on heating,and for pH.
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date is not later than 3years after date of issue from manufacturer's cold storage (5,3years).
Labeling— Label it to state that passive immunization with Immune Globulin modifies hepatitis A,prevents or modifies measles,and provides replacement therapy in persons having hypo-or agammaglobulinemia,that it is not standardized with respect to antibody titers against hepatitis Bsurface antigen and that it should be used for prophylaxis of viral hepatitis type Bonly when the specific Immune Globulin is not available,that it may be of benefit in women who have been exposed to rubella in the first trimester of pregnancy but who would not consider a therapeutic abortion,and that it may be used in immunosuppressed patients for passive immunization against varicella if the specific Immune Globulin is not available.Label it also to state that it is not indicated for routine prophylaxis or treatment of rubella,poliomyelitis,or mumps,or for allergy or asthma in patients who have normal levels of immunoglobulin,that the plasma units from which it has been derived have been tested and found non-reactive for hepatitis Bsurface antigen,and that it should not be administered intravenously but be given intramuscularly,preferably in the gluteal region.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 904
Phone Number:1-301-816-8339
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