Access to Innovation

Circumventing drug supply and distribution regulations to import prescription drugs puts patients at risk.

Currently there are a variety of initiatives from individuals, cities and states to import prescription drugs from Canada. Importing drugs from Canada can not meet the needs of the American pharmaceutical market because total Canadian pharmaceutical production represents less than 5% of the American pharmaceutical market.

The FDA and the US Customs and Border Protection recently examined a series of small shipments of foreign drugs to US consumers. These inspections revealed that these shipments often contain dangerous unapproved or counterfeit drugs. Of the 1,153 imported drugs examined, 1,019 or 88% were drugs not approved by the FDA.

Patients should be aware of the dangers associated with importing prescription medications outside of the regulated distribution system. The distribution by unregulated outlets of expired, contaminated, sub-potent or counterfeit drugs are among the potential dangers. Foreign suppliers may provide patients with incorrect or contraindicated medications, incorrect strengths, or medications without adequate directions for use. When a problem is discovered, there is little or no recourse, since the actual dispenser or prescriber may not be known, there may be no legal authority to which a complaint may be submitted and action taken, and some patients may have waived their right to sue.

For more information on the dangers of illegal or unregulated drug importation, please visit www.safecanadianmeds.ca


Industry Canada, www.ic.gc.ca/canadian_industry_statistics/cis.nsf/idE/cis3254prdE.html. Data accessed Sep 30, 2003.
FDA/US Customs Import Blitz Reveal Hundreds of Potentially Dangerous Imported Drug Shipments, September 29, 2003. (FDA Press Release)

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