PURCHASE OF IMMUNE SERUM GLOBULIN FM FOREIGN MANF 29 NOV 90

File: 970107_sep96_decls60_0001.txt
Page: 0001
Total Pages: 1

Subject: PURCHASE OF IMMUNE SERUM GLOBULIN FM FOREIGN MANF 29 NOV 90     

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003205

Folder Title: PURCHASE OF IMMUNE SERUM GLOBULIN FROM FOREIGN MANUFACTURER                                     

Document Number:          1

Folder Seq  #:         63





                                    DEPARTMENT OF THE ARMY
                                   OFFICE OF THE SURGEON GENERAL
                                        $109 LEESBURG PIKE
                                     FALLS CHURCH, VA 22041-3258
                  RE" TO
                  A@ OF
              SOPS-PSP (40-e)                                 29 Nov 90


              MEMORANDUM THRU DEPUTY DIRECTOR, PROFESSIONAL SERVICES

              FOR DIRECTORT PROFESSIONAL SERVICES

              SUBJECT: Purchase of Immune Serum Globulin (ISG) from Foreign
              Manufacturer - ACTION MEMORANDUM


              1. Purpose. To demonstrate that additional ISG 'must be
              purchased to meet Operation Desert shield requirements.

              2. Reference letter, Sclavo Company, November 26, 1990,
              subject: Supply of Immune Serum Globulin (enclosed.)

              3. Discussion.

                 a. Per conversation between COL Erdtnann and CPT Lipnick,
              SGPS-PSP, and the Defense Medical Standardization Board (D.XSB),
              insufficient supplies of ISG are available from CONUS
              manufacturers to meet requirements as a result of Operation
              Desert Shield.

                 b. D14SB stated an Italian manufacturer, Sclavo, is able to
              provide sufficient ISG to meet these requirements. Sclavo has
              an FDA license to produce some immunizations (e.g., diphtheria
              and tetanus antitoxin) in CONUS; however, their ISG produced in
              their Italian plant is not an FDA approved vdccine.

                 c. The DPSC will buy the ISG and submit samples to FDA for
              testing. When FDA completes testing (48 hours after delivery),
              they may license this product, per DMSB conversation with FDA.

              4. Recommendation. Director, Professional Services, concur
              with the purchase of ISG from Sclavo Company, if FDA approves
n the U.S.




              Encl
              as
                                                                        itary
                                                Medicine Consultants Division

              CON
              NONCONCUR

                                              RONALD R. BLANCIC
                                              Brigadier General, MC
                                              Director, Professional Services

Document 1 f:/Week-36/BX003205/PURCHASE OF IMMUNE SERUM GLOBULIN FROM FOREIGN MANUFACTURER/purchase of immune serum globulin fm foreign man:01029715474661
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003205
Unit = OTSG
Parent Organization = HSC
Folder Title = PURCHASE OF IMMUNE SERUM GLOBULIN FROM FOREIGN MANUFACTURER
Folder Seq # = 63
Subject = PURCHASE OF IMMUNE SERUM GLOBULIN FM FOREIGN MAN
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 02-JAN-1997