Federal Judge Enters Consent Decree Against Specialty Compounding Pharmacy

US District Judge Lee Yeakel has entered a consent decree of permanent injunction between the United States and a Texas compounding pharmacy.

The decree, issued March 10, 2015, centers on Specialty Compounding LLC and the company’s co-owners, Raymond L. Solano III and William L. Swail. The complaint accompanying the consent decree claims that the pharmacy manufactured sterile injectable drug products that tested positive for bacterial contamination, according to the FDA.

The consent decree prohibits the Cedar Park, Texas, facility and its owners from manufacturing, holding, or distributing sterile drugs until they comply with the Federal Food, Drug, and Cosmetic Act and its regulations, as well as other requirements.

Two Texas hospitals had reported back in August 2013 that 17 of their patients developed bacterial bloodstream infections after taking an infusion of calcium gluconate made by Specialty Compounding, according to the FDA. In response, the compounding pharmacy stopped its operations and recalled its unexpired sterile drug products that were distributed since February 1, 2013. The owners also said they would implement corrective actions before they began compounding sterile drugs again.

The FDA inspected their facility in August and September of 2013 and found that Specialty Compounding had violated current good manufacturing practice requirements and had unsanitary conditions. For example, the pharmacy did not have adequately cleaned and disinfected equipment and rooms, and it did not have sufficient laboratory testing for its injectable drugs. Analyses also showed bacterial contamination in some of the company’s injectable drugs.

“Injectable drugs must be produced under sterile conditions,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”