The District Court for the Northern District of Texas entered a consent decree of permanent injunction against defendants JMA Partners Inc., a compounding pharmacy doing business as Guardian Pharmacy Services (Guardian), and Jack R. Munn, Guardian’s owner, the Department of Justice announced today. The injunction permanently enjoins the defendants from distributing adulterated, misbranded, and unapproved new drugs in violation of the federal Food, Drug, and Cosmetic Act (FDCA).
The Department filed a complaint in the U.S. District Court for the Northern District of Texas on March 6, 2019, 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 at their drug-compounding facility. The complaint further alleges that defendants distributed misbranded and unapproved new drugs because, among other things, the drugs were distributed by the defendants without patient-specific prescriptions.
As part of the ordered permanent injunction, defendants cannot resume manufacturing, processing, or distributing sterile drugs until FDA determines that they have complied with specific remedial measures. Those measures seek to ensure that defendants manufacture and distribute drugs in conformity with applicable manufacturing standards.
“Doctors and patients must be able to rely on the safety and quality of drugs produced by compounding pharmacies,” said Assistant Attorney General Jody Hunt of the Justice Department’s Civil Division. “The Department of Justice will continue to work with FDA to enforce the provisions of the Food, Drug, and Cosmetic Act.”
According to the complaint, defendants’ drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated or may have been rendered injurious to health. For example, the complaint alleges that during a 2018 FDA Inspection, defendants used non-sterile disinfectants that were labeled as sterile throughout the facility. The complaint further alleges that defendants failed to take adequate corrective actions after documenting repeated instances of high humidity levels in an area specially designed for aseptic processing of sterile drugs. High humidity levels in aseptic processing areas can lead to an increase in the proliferation of microorganisms present in those areas.
On July 28, 2017, FDA issued a Compounding Risk Alert to warn health professionals of adverse event reports concerning at least 43 patients who were administered intravitreal (eye) injections of a drug containing triamcinolone (a steroid) and moxifloxacin (an antibiotic) compounded by Guardian. According to the FDA’s Compounding Risk Alert, these patients developed various symptoms, including vision impairment.
Guardian initiated voluntary recalls of drug products in 2016 and 2018. The 2016 recall involved certain unexpired sterile drug products, and was initiated due to a lack of sterility assurance. The 2018 recall, initiated after FDA’s 2018 Inspection, involved products within expiry intended to be sterile. Guardian also temporarily ceased sterile production at that time.
“The Food, Drug, and Cosmetic Act is designed to protect the public health,” said U.S. Attorney Erin Nealy Cox for the Northern District of Texas. “Our district is a committed partner in enforcing the provisions of the Act in the interest of public safety.”
“When the FDA finds compounders that continue to violate the law by not adhering to manufacturing requirements, and put patients at risk, we are going to hold them accountable under the law,” said FDA Commissioner Scott Gottlieb, M.D. “We’ve continued to see violative behavior among compounding pharmacies, and we’re committed to taking enforcement actions against drug compounders that threaten the public health.”
The government is represented by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Mary M. (Marti) Cherry of the U.S. Attorney’s Office for the Northern District of Texas, with the assistance of Associate Chief Counsel, Enforcement, Jennifer Argabright of the Department of Health and Human Services’ Office of General Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Northern District of Texas, visit its website at https://www.justice.gov/usao-ndtx.
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