[citation needed] HBIG is given by either intramuscular (IM) or intravenous (IV) route, depending on the preparation.

[9] HBIG is classified as pregnancy category C substance by the U.S. Food and Drug Administration.

[citation needed] HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen.

During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed.

The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus.