EDMOND, Okla. (KFOR) – An Oklahoma Drug Compounder has been ordered in federal court to follow the Federal Food, Drug and Cosmetic Act (FDCA) after allegedly violating it.
According to the United States Department of Justice, Qualgen LLC, Shaun P. Riney, Qualgen’s Chief Executive Officer, and Jasen Lavoie, Qualgen’s Director of Quality, violated the FDCA at the company’s facility in Edmond, Oklahoma.
Qualgen is an outsourcing facility registered with the U.S. Food and Drug Administration (FDA). Officials say Qualgen makes and distributes sterile drug products, including Bio-Identical Hormone Replacement Therapy pellets.
The U.S. Department of Justice says the defendants allegedly violated the FDCA by, among other things, not following written procedures applicable to the quality control unit, failing to reject drug products that did not meet specifications, and not following suitable procedures in handling complaints regarding its drug products.
“Drugs compounded in outsourcing facilities must be manufactured in conformance with applicable regulations,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with the FDA and take action against compounding drug manufacturers who fail to abide by laws designed to protect public health.”
“Failure to manufacture drugs in strict compliance with FDA requirements endangers the very people who need and rely on the quality of those medications,” said U.S. Attorney Robert J. Troester for the Western District of Oklahoma. “We gladly partner with the FDA to enforce their regulations in order to ensure public safety is maintained in the pharmaceutical manufacturing and compounding process.”
According to officials, the defendants agreed to settle the suit and be bound by a consent decree of permanent injunction without denying or admitting the allegations in the complaint.