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Sterility Concerns Prompt Shutdown of Utah-Based Compounding Pharmacy

Isomeric Pharmacy Solutions produced and distributed contaminated drugs for years, says the FDA.

Published: August 7, 2017

UNCLEAN CONDITIONS Inspectors say insanitary manufacturing conditions could have led to patient harm.

The U.S. Food and Drug Administration (FDA) has ordered Isomeric Pharmacy Solutions of Salt Lake City, Utah, to stop manufacturing and distributing medications after the compounding firm was repeatedly warned about producing potentially contaminated products, unapproved agents and misbranded drugs.

The FDA's shutdown came after inspectors on numerous occasions found Isomeric manufactured drugs in insanitary conditions that could have contaminated the drugs — including injectable and ophthalmic drugs — with "filth" that might harm patients. The FDA also says the company did not label drugs with proper instructions for use.

When FDA inspectors initially visited the facility in August 2015, they discovered supposed sterile drugs were manufactured in ways that did not guarantee sterility assurance. Although Isomeric assured the FDA it would address the agency's concerns, a follow-up inspection conducted in June 2016 showed the company did not complete corrective actions as promised. The second inspection prompted the FDA to issue a warning letter that instructed the company to undertake a comprehensive assessment of its operations.

After the FDA again found sterility issues at the facility during inspections conducted between Feb. 22 and March 24, 2017, Isomeric agreed in April 2017 to recall all products distributed to patients, providers, hospitals or clinics between Oct. 4, 2016, and Feb. 7, 2017. At that time, the company claimed it had received no reports of adverse events related to the recall.

According to the FDA's injunction order, Isomeric cannot manufacture, process, package, hold or distribute drugs until it complies with manufacturing standards the Federal Food, Drug, and Cosmetic Act (FD&C Act).

"Isomeric endangered the public health by manufacturing injectable drugs under poor conditions that compromised their required sterility and put patients at risk," says FDA Commissioner Scott Gottlieb, MD. "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."

Isomeric initially registered as an outsourcing facility in July 2015 and reregistered in December 2015 and January 2017. Isomeric did not respond to repeated calls seeking comment.

The shutdown of Isomeric calls to mind the medication contamination case involving New England Compounding Center, which was responsible for the 2012 meningitis outbreak that killed 76 people and sickened nearly 800 more. Barry Cadden, NECC's former president, was sentenced in June to 9 years in prison for racketeering conspiracy and mail fraud.

Daniel Cook

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Sterility Concerns Prompt Shutdown of Utah-Based Compounding Pharmacy

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