FDA WARNING_LETTER - PIL - September 03, 2021

The FDA issued a Warning Letter to 247RX-PILL on August 31, 2021, following a review of its website, www.247rxpill.in. The agency observed that the company is introducing unapproved and misbranded new drugs, specifically opioid and benzodiazepine products, into interstate commerce, violating sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The letter highlights the severe public health risks associated with the easy online availability of opioids and benzodiazepines, citing the opioid epidemic and the dangers of benzodiazepine nonmedical use, especially in combination with other substances. The identified violations include the sale of unapproved new drugs, such as "Tramadol Hydrochloride 100 mg SR Tablets Radol-100" and "Rivotril" (clonazepam) manufactured by Galenika, for which no FDA-approved applications exist. These products are considered misbranded under section 502(f)(1) of the FD&C Act because their labeling lacks adequate directions for use, as they are prescription drugs requiring professional supervision. The FDA emphasized that unapproved drugs lack assurances of safety and effectiveness and may be contaminated or counterfeit. 247RX-PILL is required to cease offering all violative drugs to U.S. consumers and respond within 15 working days, detailing corrective actions and prevention measures. Failure to comply could lead to legal action, including seizure and injunction, and potential detention of products if the firm is outside the U.S.