The injunction stands until the company complies with FD&C Act regulations.
A decree of permanent injunction between the United States and Isomeric Pharmacy Solutions was entered August 4 by US District Judge Robert J. Shelby.
Until it complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations, Isomeric, its owners and CEO, are prohibited from manufacturing, processing, packing, holding, or distributing drugs.
Isomeric manufactured and distributed allegedly sterile drug products, including injectable and ophthalmic medicines that had been adulterated due to creation under unsanitary conditions and in violation of the FD&C Act’s good manufacturing practice requirements, according to the complaint for permanent injunction, filed by the US Department of Justice on behalf of the Food and Drug Administration (FDA).
Additionally, the complaint also stated that Isomeric purportedly manufactured and distributed unapproved and misbranded drugs because their labels did not state adequate directions for use, according to an FDA press release.
“Isomeric endangered the public health by manufacturing injectable drugs under poor conditions that compromised their required sterility and put patients at risk,” Scott Gottlieb, MD, FDA Commissioner, said in the statement. “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.”
The FDA recently inspected Isomeric earlier this year, from Feb. 22 until March 24. The inspection resulted in a lack of sterile assurance, causing Isomeric to agree to a voluntary national recall of unexpired products produced specifically for sterilized use.
The recall included drugs that had been distributed to providers, hospitals and clinics, and patients nationwide from Oct. 2016 to Feb. 2017.
Despite assurance to the FDA that violations were being corrected, a follow-up inspection in June revealed a lack of adequate corrective actions being implemented, resulting in a warning letter being issued to Isomeric.
Isomeric had been inspected previously in Aug. 2015, with the FDA observing “poor conditions and practices” for the production of sterile drugs.