IA #57-11, 11/16/98 - IMPORT ALERT #57-11 "DETENTION WITHOUT PHYSICAL
EXAMINATION OF UNLICENSED IMMUNE GLOBULIN INTRAVENOUS (HUMAN) FROM
THE UNITED KINGDOM"
TYPE OF ALERT: Detention Without Physical Examination.
(Note: This import alert represents the Agency's current
guidance to FDA field personnel regarding the manufacturer
and products 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.)
PRODUCT : IMMUNE GLOBULIN INTRAVENOUS (HUMAN), (IGIV)
PRODUCT
CODE : 57YY99; 57DE14; 57DBI4; 57DY14; 57DY49.
NOTE: Some filers have used other product codes, such as
64TIP99 and 66VDK99. When you encounter entries of IGIV
with the wrong product code, change it to the correct code
before recording a detention recommendation.
PROBLEM : No U.S. License, Misbranding
(OASIS Charge Codes: NO LICENSE and DIRSEXMPT)
PAC : 42R800
PAF : REG, LBL
COUNTRY : United Kingdom, (GB)
MANUFACTURER/
SHIPPERS : A.D. Allen Pharmaceutical Wholesaler
Unit D Slangston Road
Loughton, England
United Kingdom
FEI #3001206859
and
B & S Durbin Ltd
240 Northolt Road
South Harrow
Middlesex, England
United Kingdom
FEI #1000615179
IMPORTER
I.D. # : ^
^
Reference : Import Bulletin IB #57-BO9, "Shortage of Immune Globulin
Intravenous (Human)" reissued on September 28, 1998.
CHARGES : "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 3 5 1 (a) [PHS
Act, Section 351(a)]."
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)]."
RECOMMENDED
BY : CBER, Office of Compliance and Biologics Quality
Division of Case Management, HFM-61O
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.
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 at
(301) 827-6201 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.
FOI : Purging is required between ^ ^.
PREPARED
BY : Alwin W. Collins, Operations & Policy SDWG, DIOP, (301)443-6553
KEY WORDS: Immune Globulin Intravenous, IGIV, license,
biologic,Sandoglobulin, Gammagard, Investigational New Drug, IND.
Date Loaded
into FIARS: November 16, 1998
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