Chicago, Illinois - A federal court entered a consent decree of permanent injunction requiring a multi-site outsourcing compounding pharmacy, headquartered in Illinois, to comply with provisions of the Federal Food, Drug, and Cosmetic Act (the Act) while manufacturing, holding, and distributing drugs.
In a complaint filed May 20, 2019, at the request of the U.S. Food and Drug Administration, the United States alleged that PharMedium Services LLC (PharMedium) violated the Act by distributing adulterated, misbranded, and unapproved new drugs in interstate commerce. As described in the complaint, PharMedium operated four registered outsourcing facilities in Tennessee, Mississippi, Texas, and New Jersey. According to the complaint, PharMedium’s drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health and because PharMedium failed to comply with current good manufacturing practices. The complaint also alleged that PharMedium distributed unapproved new drugs and misbranded drugs because PharMedium failed to comply with all of the requirements for drugs compounded in a registered outsourcing facility.
As a result of FDA inspections, PharMedium voluntarily ceased operations at one facility in Memphis, Tennessee. The company also agreed to be bound by a consent decree filed with the complaint in the U.S. District Court for the Northern District of Illinois. In addition, Scott Aladeen, PharMedium’s new president, and Warren Horton, PharMedium’s new vice president for Quality and Research & Development, are named in the complaint and consent decree as the individuals responsible for establishing and maintaining PharMedium’s current and future compliance with the Act.
“The Department of Justice is committed to ensuring that compounding pharmacies follow safety laws that protect consumers,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “We will continue to work with the FDA to ensure that drugs are manufactured and distributed appropriately under the law.”
“PharMedium exposed patients across the United States to risk of receiving a harmful drug, which we find unacceptable,” said Acting FDA Commissioner Ned Sharpless M.D. “We will continue to take appropriate enforcement actions when compounding pharmacies and outsourcing facilities produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm to patients.”
The consent decree entered by the court permanently enjoins the defendants from violating the Act. As part of the settlement, PharMedium may not manufacture, hold, or distribute its drugs from the Memphis facility unless PharMedium complies with specific remedial measures set forth in the consent decree. PharMedium must also comply with remedial measures to ensure compliance with the Act at its other facilities and at its headquarters in Illinois.
Trial attorneys Shannon Pedersen and Claude Scott of the Civil Division’s Consumer Protection Branch represented the United States, along with the assistance of Associate Chief Counsel Laura Akowuah of the FDA’s Office of Chief Counsel and the U.S. Attorney’s Office for the Northern District of Illinois.
