ElectRx and Health Solutions, LLC – FDA Warning Letter, Mar 14, 2023

On March 2, 2023, the FDA issued a Warning Letter to ElectRx and Health Solutions, LLC ("ElectRx") for 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.

ElectRx acts as a broker, contracting with U.S. employers to provide prescription drugs to employees by facilitating dispensing from foreign pharmacies directly to U.S. consumers. The FDA found that ElectRx's business model substitutes FDA-approved drugs with unapproved foreign versions, as evidenced by invoices and formularies stating that medications may differ in name, presentation, or strength from U.S. products.

This practice poses significant health risks, especially for drugs subject to Risk Evaluation and Mitigation Strategy (REMS) programs, Narrow Therapeutic Index (NTI) drugs, controlled substances, or those for serious conditions like HIV or cancer. Unapproved drugs lack FDA oversight regarding safety, effectiveness, quality, and manufacturing controls, potentially being contaminated, counterfeit, or having varying active ingredients. The letter cites "Advagraf" (tacrolimus extended-release capsules) as an example of an unapproved NTI drug provided by ElectRx.

Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act because they lack adequate directions for use by a