A-A-0051910(DM)
30 March 1987
INTERIM COMMERCIAL ITEM DESCRIPTION
GLOBULIN, RHO(D) Immune
The General Services Administration has authorized the use of this Interim Commercial Item Description which was developed by the Defense Personnel Support Center, Directorate of Medical Materiel, DPSC-RST, 2800 South 20th Street, Philadelphia, PA 19101, based upon currently available technical information.
Salient characteristics:
Shall be a sterile, lyophilized, water soluble Globulin, Rho(D) Immune, Human, for intramuscular injection.
Shall contain 0.2 gram human immunoglobulin anti-Rho(D) within the applicable assay limits.
The Globulin, Rho(D) Immune, Human, shall be prepared by a cold alcohol method of fractionation from human plasma found noncreative for hepatitis B surface antigen (HBsAg) by a licensed test.
When reconstituted as directed on the labeling, the resulting solution shall be in accordance with the USP requirements for Rho(D) Immune Globulin, USP.
Samples of the final, filled immediate containers shall be submitted as follows:
The quality assurance representative, when inspection is at source, or the contractor, when inspection is at destination, shall sent the following by the fasted route directly to:
Department of Biologics Research
Division of Communicable Disease and Immunology
Walter Reed Army Institute of Research, Bldg 40
ATTN: Mr. Calvin Powell, Room 2022
Washington, DC 20307-5100
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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