Judge Enters Consent Decree Against Specialty Compounding LLC
Drugs manufactured by the company were found to be contaminated, according to the U.S. Department of Justice and FDA.
U.S. District Judge Lee Yeakel has entered a consent decree of permanent injunction between the United States and Specialty Compounding LLC as well as the company's co-owners, Raymond L. Solano and William L. Swail, the U.S. Department of Justice and the FDA announced. According to the complaint, Specialty Compounding manufactured purportedly sterile injectable drug products at a facility in Cedar Park, Texas, that tested positive for bacterial contamination. The company distributed the drugs to hospitals, surgery centers, and health clinics in Texas and throughout the United States, DOJ reported. Solano is Specialty Compounding's pharmacist-in-charge and co-owner, and Swail is Specialty Compounding's Managing Partner and co-owner.
The consent decree prohibits Specialty Compounding and its owners from manufacturing, holding, or distributing sterile drugs until they comply with the Federal Food, Drug, and Cosmetic Act and its regulations.
"Injectable drugs must be produced under sterile conditions," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research. "Specialty Compounding's manufacturing practices and products put patients at risk. This consent decree reflects the FDA's commitment to taking enforcement action against companies that fail to produce sterile drugs in compliance with the law."
In August 2013, the FDA received reports that 17 patients had developed bacterial bloodstream infections after receiving an infusion of the drug calcium gluconate manufactured by Specialty Compounding. The company then ceased sterile drug manufacturing operations and recalled all of its unexpired sterile drug products.