Examinations find unapproved imported medications

AORN Journal,  April, 2004  

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Large quantities of medications that are not approved by the US Food and Drug Administration (FDA) continue to be exported to the United States from foreign countries, according to a Jan 27, 2004, news release from the FDA. Import blitz examinations conducted by the FDA and the US Customs and Border Protection agency (CBP) found 1,728 unapproved medications, including foreign versions of FDA-approved medications, recalled medications, medications that require special storage conditions or close physician monitoring, addictive controlled substances, and investigational products. These illegally imported prescription medications cannot be guaranteed for safety, effectiveness, quality, or purity.

The blitz examinations took place in Buffalo, Dallas, Chicago, and Seattle mail facilities and the Memphis and Cincinnati courier hubs in November 2003. A total of 1,982 parcels that appeared to contain medication products were examined, regardless of the country from which they were sent, and the majority of the parcels were found to contain medications. Approximately 80% of the parcels came from Canada and 16% came from Mexico. The remaining 4% were sent from Japan, the Netherlands, Taiwan, Thailand, and the United Kingdom.

Although the FDA and the CBP do not have the resources to perform comprehensive examinations of all parcels marled or brought into the United States by commercial couriers, they plan to continue blitz operations on medication imports. The FDA also plans to

* focus more strategically on foreign sources of imported medications,

* work with commercial shippers to identify the shipping patterns of medication vendors,

* form partnerships with other state, federal, and international regulatory and law enforcement agencies to combat illegal imports, and

* continue to educate the public about the dangers of illegally imported medications.

Recent FDA/US Customs Import Blitz Exams Continue to Reveal Potentially Dangerous Illegally Imported Drug Shipments (news release, Rockville, Md: US Food and Drug Administration, Jan 27, 2004) http://www.fda.gov/bbs /topics/NEWS/2004/NEW0111.html (accessed 2 Feb 2004).

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