FDA WARNING_LETTER - Discount Online Pharmacy

The FDA issued a Warning Letter to www.topsavingspharmacy.com after reviewing its website, determining that it offers unapproved and misbranded new drugs for sale, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the website offers "Generic Tamiflu," which is an unapproved new drug as no applications under section 505(a) of the FD&C Act are in effect for it, making its introduction into interstate commerce prohibited under section 301(d). Furthermore, the drugs are misbranded in several ways. They are offered for sale without requiring a prescription from a licensed practitioner, violating section 503(b)(1). Their labeling is false or misleading under section 502(a) because it implies FDA approval. Additionally, the labeling fails to bear adequate directions for use, as the drug treats conditions not amenable to self-diagnosis, violating section 502(f)(1). The FDA emphasizes the inherent risks of unapproved and misbranded drugs from unregulated sources, citing concerns about safety, effectiveness, contamination, and counterfeiting. The firm is required to immediately cease marketing these violative products to U.S. consumers and notify the FDA within 15 working days of corrective actions taken or planned. Failure to comply may lead to regulatory actions like seizure or injunction.