FDA WARNING_LETTER - Sun Drug Store

The FDA issued a Warning Letter to SunDrugStore.com after reviewing its website and determining that it offers unapproved and misbranded new drugs for sale, violating sections 502(a), 502(f)(1), 503(b)(1), and 505(a) of the FD&C Act. Specifically, the website offers "Generic Tamiflu," an unapproved new drug, into interstate commerce, which is prohibited under sections 301(a) and 301(d). The drugs are also misbranded because they are offered for sale without requiring a valid prescription, with the firm's "on-staff physician" issuing prescriptions without examination, which the FDA does not consider valid. Furthermore, the labeling is false or misleading, implying FDA approval, and fails to bear adequate directions for use, as the conditions treated are not amenable to self-diagnosis. The FDA emphasized the inherent risks of unapproved and misbranded drugs from unregulated sources, including potential contamination or incorrect ingredients. SunDrugStore.com is required to immediately cease marketing these violative products and notify the FDA within 15 working days of corrective actions taken or planned to prevent recurrence. Failure to comply may result in regulatory actions such as seizure or injunction.