"Detention Without Physical Examination Of Reimportation Of Insulin"

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506 of the Act (21 USC 356), concerning certification of products composed wholly or partly of insulin, has been repealed.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.

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) 796-6600.

Insulin

"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)."

OASIS CHarge Code - AGRINSULIN