On Monday, August the 7th, the United States District Court for the District of Utah announced it had entered a permanent injunction to prevent Isomeric Pharmacy Solutions and its executives from distributing adulterated, misbranded and unapproved new drugs. The injunction will impact the company’s CEO, William O. Richardson, its Chief Sales Office Rachael S. Cruz, and its Chief Operating Officer Jeffery D. Brown. The complaint was filed in the U.S. District Court on July the 27th after the Department received a request from the FDA.
The defendants are accused of failing to adequately address insanitary conditions, which ultimately lead to contamination in processing areas used by Isomeric. Isomeric manufactures labels and distributes sterile drugs, such as injectable hormones, corticosteroids, and ophthalmic drops. Most of the drugs produced by Isomeric are directly distributed to physicians in the United States.
In the complaint, the pharmacy is accused of manufacturing these drugs in conditions that fall well below the minimum requirements for safety and quality. In 2016, Isomeric was forced to initiated three voluntary recalls. A fourth came in 2017 after an inspection was carried out by the FDA. The 2016 recalls involved three types of drugs.
In April of 2017, the pharmacy recalled all lots of non-expired drugs, which were intended to be sterile. The drugs were compounded and distributed between October the 4th of 2016 and February the 7th of 2017. During the FDA’s inspection in 2017, several insanitary conditions were exposed. The FDA observed that different microorganisms were recovered from the air and on surfaces that were used for sterile processing. Isomeric’s own records indicated the same.
Isomeric was also accused of distributing more than 100 batches of supposedly sterile products that were processed in areas containing particles in excess of the pharmacy’s action limit for particulates. FDA Commissioner Scott Gottlieb stated the following. “Isomeric endangered the public health by manufacturing injectable drugs under poor conditions that compromised their required sterility and put patients at risk.”
Subsequently, the FDA discovered that Isomeric deviated from current good manufacturing practice requirements. They are accused of failing to thoroughly review and investigate unexplained discrepancies, as well as the failure of a batch to meet any of its specifications. As an example, Isomeric was accused of allowing a vial of product to pass visual inspection, despite black particles being observed in said vials. An adequate investigation was never conducted.
The defendants in the case have agreed to settle and abide by the permanent injunction. The defendants have agreed to not manufacture or distribute any medications, until they comply with the remedial measures set forth in the order. The firm will also be required to hire a qualified independent expert to help recommend and direct further corrective actions. Finally, the pharmacy will need to implement changes to ensure thorough investigations are always conducted when unexplained discrepancies are experienced.