IA #66-65 - 3/5/98, IMPORT ALERT #66-65, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF REIMPORTATION OF INSULIN"
(NOTE: This import alert represents the Agency's current guidance to FDA field personnel
regarding the manufacturer(s) and/or product(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.)
TYPE OF ALERT : Detention Without Physical Examination
PRODUCT : Insulin
PRODUCT CODE : 61P17, 61P23
PROBLEM : Reimportation of Insulin - OASIS Charge: AGRINSULIN
PAF (Problem
Area Flag) : AAP
PAC FOR
COLLECTION : 56008H
COUNTRY : United States
MANUFACTURER
and FEI : N/A
SHIPPER
and FEI : N/A
CONSIGNEE
and FEI : N/A
CHARGE : "The article is subject to refusal of admission pursuant to Section 801(d)(1)
in that it is a drug composed wholly or partly of insulin, manufactured in
the United States and offered for import by a party other than the
manufacturer, and reimportation has not been authorized by the Secretary
for use in a medical emergency as provided under Section 801(d)(2)."
RECOMMENDING
OFFICE : CDER/Office of Compliance/Division of Prescription Drug Compliance
and Surveillance, HFD-330
REASON FOR
ALERT : Section 801(d)(1) of the FD&C Act was amended on November 21, 1997,
under the FDA Modernization Act of 1997. This provision of the Act is
generally referred to as the American Goods Returned provision. The Act
has been amended to include products composed wholly or partly of
insulin. Therefore, insulin manufactured in the United States and exported,
may not be re-imported into the United States unless the insulin is imported
by the manufacturer of the drug. Further, Section 506 of the Act (21 USC
356), concerning certification of products composed wholly or partly of
insulin, has been repealed. Therefore, insulin no longer needs to be
certified by FDA to be legally shipped in interstate commerce. Insulin
products continue to require effective new drug applications under section
505 of the Act. In addition, they must meet the requirements of sections
501 and 502, in that they must not be adulterated or misbranded.
GUIDANCE : Districts may detain without physical examination all products composed
wholly or partly of insulin, with the United States as the country of origin
(American Goods Returned), when:
801(d)(1): the product is imported by a party other than the manufacture
of the drug; and
801(d)(2): the reimportation is not authorized by the Secretary (or a
delegated authority) in the case of a medical emergency.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology, contact the
Division of Field Science at (301) 443-3320 or 3007.
PRIORITIZATION
GUIDANCE : II
FOI : No purging is required.
KEYWORDS : Insulin, American Goods Returned
PREPARED BY : Fredda C. Shere-Valenti, DIOP, (301) 443-6553
DATE LOADED
INTO FIARS : March 5, 1998
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