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# FDA Warns CanaRx Over Unapproved Drugs
- URL: https://www.fdaweb.com/fda-warns-canarx-over-unapproved-drugs/
- Published: 2019-03-01T12:00:00.000Z
- Updated: 2026-09-15T01:09:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143506

FDA has issued a [Warning Letter ](http://fda.pr-optout.com/Tracking.aspx?Data=HHL%3d84%3c5A7-%3eLCE38%2b87%3e7-GLCE17.6&RE=MC&RI=4528954&Preview=False&DistributionActionID=96821&Action=Follow+Link&ref=fdaweb.com)to CanaRx for causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers. The letter outlines the company’s “scheme” to contract with public and private entities to provide prescription drug coverage to their employees. “In the scheme, CanaRx facilitates foreign physicians rewriting the employee’s U.S. prescription, and then supplies the employee with unapproved versions of FDA-approved drugs purportedly sourced from Canada, the United Kingdom or Australia that are represented to have undergone review from those countries’ drug regulatory systems,” FDA says. “This is particularly troublesome, as employees are likely inclined to trust that they will receive safe and effective drugs through their employer’s ‘insurance’ plan and may not question their legitimacy.”

In addition, the agency says several of the unapproved drugs offered by CanaRx have different trade names and dosage amounts in their labeling than their FDA-approved counterparts. “Such differences can cause patient confusion and lead to medication errors,” it says.