The Iowa Board of Pharmacy has announced the filing of charges against FarmaKeio, a mail-order compounding pharmacy, citing violations of the federal Food, Drug and Cosmetics Act. This action follows warnings from the U.S. Food and Drug Administration (FDA) and actions by the California Board of Pharmacy. A hearing is scheduled for July 18.
According to the Iowa Capital Dispatch, the board's legal action targets FarmaKeio, based in Texas, due to alleged breaches of federal regulations. The FDA had previously issued a warning in 2022 advising healthcare providers against using sterile products from FarmaKeio because of potential contamination risks. This case highlights growing regulatory scrutiny on compounding pharmacies across various states.
The California Board of Pharmacy has also taken action against FarmaKeio, accusing it of providing false information to investigators, shipping compounded hormonal pellets from an unlicensed facility, and distributing adulterated drugs contrary to FDA restrictions. The board seeks to revoke FarmaKeio’s nonresident compounding pharmacy license and bar its CEO, Daniel Deneui, from managerial roles if the license is placed on probation. The case remains pending.
Amidst increased enforcement actions against compounding pharmacies, companies such as Empower Pharmacy and Hims & Hers have encountered legal challenges from major pharmaceutical manufacturers. According to the Houston Chronicle, Empower Pharmacy is contesting a lawsuit filed by Eli Lilly alleging that it sold unapproved versions of diabetes and weight loss drugs. Empower contends that it offers personalized and affordable care that challenges traditional mass-produced commercial drug models. Similarly, Hims & Hers faced termination of its partnership with Novo Nordisk over allegations related to unauthorized versions of its weight-loss drug Wegovy. Despite these challenges, both companies stress their commitment to patient safety and personalized treatment options.
The Iowa Board of Pharmacy oversees the practice of pharmacy within Iowa, ensuring compliance with state and federal laws to protect public health and safety. It regulates state-licensed pharmacies, pharmacists, and pharmacy technicians while investigating complaints and taking disciplinary actions when necessary.
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