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Thursday, August 10, 2017
DOJ Press Release: District Court Enters Permanent Injunction Against Utah Pharmacy and Its Executives to Prevent Distribution of Adulterated, Misbranded and Unapproved New Drugs
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Monday, August 7, 2017
District Court Enters Permanent Injunction Against Utah Pharmacy and Its Executives to Prevent Distribution of Adulterated, Misbranded and Unapproved New Drugs
The U.S. District Court for the District of Utah entered a consent decree of permanent injunction against defendants Isomeric Pharmacy Solutions LLC (Isomeric), William O. Richardson, who serves as its Chief Executive Officer, Rachael S. Cruz, who serves as its Chief Sales Officer, and Jeffery D. Brown, who serves as its Chief Operating Officer. The injunction permanently enjoins the defendants from distributing adulterated, misbranded and unapproved new drugs in violation of the federal Food, Drug, and Cosmetic Act.
The Department filed a complaint in the U.S. District Court for the District of Utah on July 27, at the request of the U.S. Food and Drug Administration (FDA), alleging, among other things, that the defendants failed to adequately address insanitary conditions that resulted in contamination in certain processing areas used by Isomeric.
According to the complaint, Isomeric manufactures, labels, and distributes sterile drugs, including injectable hormones, injectable corticosteroids, and ophthalmic drops. The pharmacy distributes most of its drugs directly to physicians throughout the United States. According to the complaint, Isomeric has a history of manufacturing injectable and ophthalmic drug products under conditions that fall short of the minimum requirements to ensure safety and quality.
“Compounding pharmacies must produce their drugs in a way that does not potentially endanger patient safety,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work actively with FDA to ensure that compounding pharmacies comply with the law and provide safe products that doctors and patients can rely on.”
Isomeric initiated three voluntary recalls in 2016, and a fourth in 2017 following an FDA inspection. The 2016 recalls involved three types of injectable suspension drugs: triamcinolone diacetate 40 mg/mL, methylprednisolone acetate/lidocaine HCl 40/10 mg/mL, and betamethasone acetate/betamethasone sodium phosphate. On April 6, 2017, Isomeric recalled all lots of non-expired drug products intended to be sterile that the pharmacy compounded and distributed nationwide between Oct. 4, 2016, and Feb. 7, 2017.
According to the complaint, FDA documented a number of insanitary conditions during a 2017 inspection of Isomeric. FDA observed, following a review of the pharmacy’s own records, that Isomeric repeatedly recovered several types of microorganisms in the air and on surfaces used for sterile processing, demonstrating that products manufactured in those areas were prepared, packed, or held under insanitary conditions, as alleged in the complaint. The complaint further alleges that Isomeric released for distribution over 100 batches of purportedly sterile finished products that had been processed in one or more areas containing particles in excess of the pharmacy’s “action limit” for particulates.
“Isomeric endangered the public health by manufacturing injectable drugs under poor conditions that compromised their required sterility and put patients at risk,” said FDA Commissioner Scott Gottlieb, M.D. “We will continue taking strong enforcement actions against compounders who violate the Drug Quality and Security Act and put patients at risk by failing to produce sterile drugs in compliance with the law.”
In addition, according to the complaint, FDA found deviations of current good manufacturing practice requirements in the pharmacy’s sterile drug manufacturing operations. As alleged in the complaint, Isomeric failed to thoroughly review and investigate unexplained discrepancies and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch was already distributed. In one example, according to the complaint, Isomeric failed to conduct an adequate investigation of black particles observed in vials of product that had “passed” visual inspection.
“The Food, Drug, and Cosmetic Act is designed to protect patients from unsafe drugs,” said U.S. Attorney John W. Huber for the District of Utah. “Today’s enforcement action demonstrates our commitment to ensuring that when deficiencies in drug compounding are identified, they are properly addressed. We will take whatever actions are necessary to reduce the risk to patients who rely on such drugs.”
The defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction. As part of the resolution, defendants agree not to resume manufacturing, holding or distributing drugs until they comply with specific remedial measures set forth in the order entered by the Court. Among other requirements, the defendants must hire a qualified independent expert to recommend and direct the implementation of corrective actions. The decree also specifically requires that defendants establish and implement procedures to ensure a thorough investigation of any unexplained discrepancy or failure in a drug batch, regardless of whether the batch has been distributed.
The government is represented by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Sandra L. Steinvoort of the U.S. Attorney’s Office for the District of Utah, with the assistance of Senior Counsel Claudia J. Zuckerman of FDA’s Office of the Chief Counsel, Department of Health and Human Services.