A Federal judge has entered a consent decree of permanent injunction against Isomeric Pharmacy Solutions, a registered outsourcing facility under section 503B of the US Food and Drug Administration (FDA) Federal Food, Drug, and Cosmetic Act (FD&C Act).
The consent decree prohibits the company, its owners, and chief operating officer from manufacturing, processing, packing, holding, or distributing drugs – until it is in compliance with the FD&C Act, its regulations, and other requirements.
As Outsourcing-Pharma.com previously reported, 503B facilities were established as a new category of outsourcing facilities in 2013 as part of the Drug Quality and Security Act (DQSA).
Compounding quality concerns
Drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 DQSA.
Letters have been sent to the Appropriations Committees of the US Senate and the US House of Representatives, as well as to the US FDA.
According to the FDA, Isomeric manufactured and distributed “purportedly sterile drug products, including injectable and ophthalmic drugs that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act.”
Additionally, the complaint claims that the company manufactured and distributed unapproved drugs and drugs that were misbranded.
In the release, FDA Commissioner Scott Gottlieb, M.D. explained:
“Isomeric endangered the public health by manufacturing injectable drugs under poor conditions that compromised their required sterility and put patients at risk. 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.”
FDA inspections and recalls
Most recently, the FDA inspected Isomeric from February 22 to March 24, 2017, at which time the company received a Form 483. On April 7, 2017, the company issued a voluntary nationwide recall of lots of sterile products it compounded and packaged.
According to the recall notification, the FDA raised concerns around the product lots during the inspection, specifically as it pertained to “a lack of sterility assurance for its purportedly sterile drug products.” The company noted it has not received any adverse events reports related to the product lot.
The FDA first observed similar “poor conditions and practices” during an inspection of the company in August 2015. The company was issued a Form 483 at this time.
A follow-up inspection in June 2016 “revealed that the company had not implemented adequate corrective actions,” according to the FDA, “despite assurances that Isomeric was correcting its violations.” On June 29, 2016, the company was issued another Form 483 and in December 2016, a warning letter.
Isomeric Pharmacy Solutions did not respond to a request for comment.