FDA WARNING_LETTER - CanaRx Services Inc - February 28, 2019

On February 26, 2019, the FDA issued a Warning Letter to Mr. Gregory Anthony Howard, addressing CanaRx Services Inc/CRX Intl and its affiliates. The FDA determined that CanaRx is causing the introduction of unapproved new drugs and misbranded drugs into interstate commerce, violating sections 301(a), 301(d), and 505(a) of the FD&C Act.

CanaRx operates as a prescription drug provider, contracting with U.S. employers to provide prescription drugs to employees by acting as a broker between foreign pharmacies and employer-sponsored health insurance plans. CanaRx accepts U.S. prescriptions, facilitates their reissue by foreign physicians, and then foreign pharmacies ship the drugs directly to U.S. employees. The use of a templated invoice with a disclaimer about potential differences in medication appearance indicates a design to substitute FDA-approved drugs with unapproved ones.

These products are considered "new drugs" under section 201(p) of the FD&C Act because they lack general recognition of safety and effectiveness for their labeled uses and have no FDA-approved applications. Their introduction into interstate commerce thus violates sections 301(d) and 505(a). The FDA highlighted significant health risks, including the lack of safeguards for recalls, potential for patient confusion and medication errors due to different trade names and dosages, and the risk of receiving subpotent, super