The US Food and Drug Administration (FDA) has taken legal action to prevent a compounding pharmacy from manufacturing or holding sterile drugs, following complaints that injectable drug products were contaminated with bacteria.
The consent decree, taken out against Speciality Compounding in Texas and its owners, means that manufacture of the drugs is halted until FDA inspectors are confident that the company is meeting expected legal manufacturing quality standards.
“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,” says Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
The action was taken after two hospitals in Texas claimed in August 2013 that 17 patients had developed bacterial bloodstream infections after receiving an infusion of calcium gluconate manufactured by the company. The company stopped sterile drug production immediately and recalled products distributed since February that year.
The hospital complaints triggered FDA inspections of the manufacturing site in August and September 2013 which found that the company had broken good manufacturing guidelines. Some of its injectable drugs were contaminated with bacteria and the company had not adequately cleaned and disinfected equipment or rooms, the inspectors discovered. It also failed to adequately test its injectable drugs in its laboratories.
The consent decree, which is similar to a UK injunction, was entered on 10 March 2015.