The compounder caught the US Food and Drug Administration’s (FDA) in August 2013 when 17 people infused with calcium gluconate made at its site in Cedar Park developed bacterial bloodstream infections.
Speciality Compounding halted production and recalled all sterile products distributed since February 2013. The firm’s owners also said they would implement corrective measures, but an inspection at the site a few months later uncovered unsanitary conditions.
The FDA team also determined that the firm lacked the specialist laboratory capacity needed to test the sterility of pharmaceutical products.
The new injunction issued by the US District Court for the Western District of Texas this week prohibits the firm and owners Raymond Solano III and William Swail from making, storing or shipping drugs until their site facility complies with Federal regulations.
Speciality Compounding joins the list of pharmacies criticised in a US FDA crackdown prompted by the death of 64 people given contaminated methylprednisolone made by the New England Compounding Center (NECC) in 2012.
The NECC case – which resulted in the arrest of supervising pharmacist, Glenn Chin, in September last year – was followed by cautions for Arizona’s Zion Rx Formulation Services, Florida’s Compounding Shop and Texas’s NuVision Pharmacy.
The focus on compounders continued last month when executives for Med Prep Consulting were accused of committing fraud and violating the Federal Food, Drug and Cosmetic Act (FDCA) by the US DoJ for knowingly selling drugs produced in unsanitary conditions.
The DoJ indicted Med Prep’s owner Gerald Tighe and chief pharmacist Stephen Kalinoski accusing them of engaging “in a disturbing pattern of dangerous practices in order to save money and line their pockets” and warned that the two men could face imprisonment.