Iowa board files charges against mail-order pharmacy cited by FDA and California board

Three years after federal regulators warned medical providers to avoid using certain products from a mail-order pharmaceutical company, the Iowa Board of Pharmacy is taking action against the company.

The board has charged the Iowa-licensed compounding pharmacy FarmaKeio, located in Richardson, Texas, with violating provisions of the federal Food, Drug and Cosmetics Act. The board has not disclosed the specific nature of the violations or stated when they occurred.

However, in April 2022, the Food and Drug Administration publicly warned patients and medical providers to refrain from using any FarmaKeio products that were intended to be sterile.

The warning followed an FDA inspection of FarmaKeio facilities in which regulators claimed to have “observed conditions that could cause the drugs produced by the company to become contaminated or otherwise pose risks to patients.” The FDA recommended the company voluntarily recall certain products.

The FDA also advised health care professionals to check their medical supplies, quarantine any FarmaKeio drugs that were intended to be sterile, and not administer them to patients.

A hearing on the Iowa Board of Pharmacy charge is scheduled for July 18, 2025.

In a separate matter, FarmaKeio currently facing charges from the California Board of Pharmacy. The board’s executive director alleges FarmaKeio provided false information to board investigators in an effort to subvert a board investigation; committed unprofessional conduct by shipping 92 prescriptions for compounded hormonal pellets to California that were obtained from a facility not licensed in California; furnished patients with compounded drug preparations that were adulterated; and provided compounded drugs in violation of FDA restrictions.

In that case, the California board’s executive director is seeking to revoke FarmaKeio’s nonresident compounding pharmacy license and to bar the company’s chief executive officer, Daniel Deneui, from serving as a manager, administrator, officer or partner for five years if the company’s license is placed on probation.

The case is still pending.