Import Alert 57-11
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 57-11
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Unlicensed Immune Globulin Intravenous (Human) From the United Kingdom"
Reason for Alert:
In January of 1998, FDA issued an import bulletin regarding the shortage of the product Immune Globulin Intravenous, (Human) (IGIV). There are only three U.S. licensed foreign manufacturers of IGIV who may legally export the product to the United States for commercial distribution: Central Laboratory Blood Transfusion Service Swiss Red Cross located in Switzerland (U.S. License No. 0647); Osterreichisches Institut fuer Haemoderivate Ges.m.b.H located in Austria (U.S. License No. 0258); and Baxter Healthcare Corporation, Hyland located in Belgium (U.S. License No. 0140).
Although these three foreign establishments have an U.S. license for the manufacture of IGIV, these firms also manufacture unlicensed versions of IGIV for other countries, such as the United Kingdom and Germany. Only IGIV manufactured under the U.S. license and bearing the U.S. license number on its labeling may be imported into the United States unless the unlicensed version of IGIV has an Investigational New Drug (IND) application accepted by the Center for Biologics Evaluation and Research.
In August 1998, unlicensed versions of IGIV under the name Sandoglobulin, manufactured by Central Laboratory Swiss Red Cross in Switzerland but labeled for Germany and the United Kingdom were offered for import by A.D. Allen Pharmaceutical Wholesaler and B & S Durbin Ltd. and were subsequently detained and refused entry. The unlicensed versions of Sandoglobulin were not manufactured under the conditions of the U.S. license issued to Central Laboratory Swiss Red Cross and the labeling did not bear a U.S. License number.
In addition, an unlicensed version of IGIV under the name Gammagard, manufactured by Baxter Healthcare Corporation, Hyland in Belgium, was offered for import by A.D. Allen Pharmaceutical Wholesaler and was subsequently detained and refused entry. The unlicensed version of Ganmagard was not manufactured under the conditions of the U.S. license issued to Baxter Healthcare Corporation, Hyland and the labeling did not bear an U.S. License number.
Although these three foreign establishments have an U.S. license for the manufacture of IGIV, these firms also manufacture unlicensed versions of IGIV for other countries, such as the United Kingdom and Germany. Only IGIV manufactured under the U.S. license and bearing the U.S. license number on its labeling may be imported into the United States unless the unlicensed version of IGIV has an Investigational New Drug (IND) application accepted by the Center for Biologics Evaluation and Research.
In August 1998, unlicensed versions of IGIV under the name Sandoglobulin, manufactured by Central Laboratory Swiss Red Cross in Switzerland but labeled for Germany and the United Kingdom were offered for import by A.D. Allen Pharmaceutical Wholesaler and B & S Durbin Ltd. and were subsequently detained and refused entry. The unlicensed versions of Sandoglobulin were not manufactured under the conditions of the U.S. license issued to Central Laboratory Swiss Red Cross and the labeling did not bear a U.S. License number.
In addition, an unlicensed version of IGIV under the name Gammagard, manufactured by Baxter Healthcare Corporation, Hyland in Belgium, was offered for import by A.D. Allen Pharmaceutical Wholesaler and was subsequently detained and refused entry. The unlicensed version of Ganmagard was not manufactured under the conditions of the U.S. license issued to Baxter Healthcare Corporation, Hyland and the labeling did not bear an U.S. License number.
Guidance:
Districts may detain without physical examination all foreign manufactured unlicensed versions of Immune Globulin Intravenous (Human), IGIV, shipped by A.D. Allen Pharmaceutical Wholesalers and B & S Durbin Ltd., United Kingdom.
Districts should determine whether the IGIV is covered by an unrevoked and unsuspended U.S. license or an accepted Investigational New Drug (IND) application. Districts encountering a shipment of foreign manufactured unlicensed IGIV should contact the Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Import/Export Team to verify if an IND is in effect for that IGIV product.
In addition, FDA personnel may use their enforcement discretion to release shipments of IGIV from unlicensed foreign sources that are not covered by an IND when the purpose and quantity are clearly for personal use.
Districts should determine whether the IGIV is covered by an unrevoked and unsuspended U.S. license or an accepted Investigational New Drug (IND) application. Districts encountering a shipment of foreign manufactured unlicensed IGIV should contact the Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Import/Export Team to verify if an IND is in effect for that IGIV product.
In addition, FDA personnel may use their enforcement discretion to release shipments of IGIV from unlicensed foreign sources that are not covered by an IND when the purpose and quantity are clearly for personal use.
Product Description:
Immune Globulin Intravenous (Human) (IGIV)
Charge:
"The article is subject to refusal of admission pursuant to Section 801 (a)(3) in that the article appears to be a biological product manufactured at an establishment that does not hold an unsuspended and unrevoked license issued under the Public health Service Act, Section 351(a) [PHS Act, Section 351(a)]."
OASIS charge code - NO LICENSE
And
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article does not appear to contain adequate directions for use, and the article does not appear to be exempt from such requirements [MISBRANDING, Section 502(f)(1)]."
OASIS charge code - DIRSEXMPT
OASIS charge code - NO LICENSE
And
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article does not appear to contain adequate directions for use, and the article does not appear to be exempt from such requirements [MISBRANDING, Section 502(f)(1)]."
OASIS charge code - DIRSEXMPT
UNITED KINGDOM
A.D. Allen Pharmaceutical Wholesaler
Date Published : 09/10/2009
Unit D 5langston Road , Loughton, UNITED KINGDOM
57 D B - 14 Immune Serum Globulin (Human) (Blood and Blood Derivatives)
Date Published: 09/10/2009
57 D E - 14 Immune Serum Globulin (Human) (Blood and Blood Derivatives)
Date Published: 09/10/2009
B & S Durbin Ltd
Date Published : 09/10/2009
240 Northolt Road , Middelsex, UNITED KINGDOM
57 D B - 14 Immune Serum Globulin (Human) (Blood and Blood Derivatives)
Date Published: 09/10/2009
57 D E - 14 Immune Serum Globulin (Human) (Blood and Blood Derivatives)
Date Published: 09/10/2009
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