Another compounding pharmacy has been targeted by FDA-initiated legal action for manufacturing drugs in an unsanitary facility. A federal judge issued a permanent injunction on Wednesday against Specialty Compounding, whose contaminated drugs gave bacterial bloodstream infections to 17 patients in 2013.
The injunction prevents co-owners Raymond Solano III and William Swail from reopening the compounding pharmacy in Cedar Park, TX, near Austin until upgrades are made and the FDA deems it safe for making sterile products. According to a Justice Department announcement, the men agreed to the stipulations as part of a settlement of litigation brought by the department.
Specialty Compounding recalled all of its products in 2013 after Texas hospitals reported infections in patients who received infusions of its calcium gluconate. The FDA swooped in to inspect, and culture samples found one of the drugs contaminated with bacteria. Inspectors found a facility that was not carefully cleaning its equipment and didn't have "adequate laboratory testing" for the drugs it was shipping out. Federal authorities said its "manufacturing practices posed a serious risk to the public health."
It is the third legal action against a compounder that the FDA has taken in rapid succession. Last month Tinton Falls, NJ-based Med Prep Consulting, its owner and pharmacist-in-charge were named in a 37-count indictment that accuses them of intentionally defrauding the FDA and hospitals by making drugs in less-than-sterile conditions. The most extensive action came late last year against New England Compounding Center (NECC). Fourteen owners and employees of the now-defunct Framingham, MA, company were named in a 73-count indictment that included 25 counts of second-degree murder against its two lead pharmacists.
A fungal meningitis outbreak tied to NECC in 2012 spurred the agency to begin a crash campaign to inspect all of the largest compounders in the country, inspections that led to the latest actions.The meningitis outbreak infected 751 people who received injections of an NECC-compounded steroid drug. Sixty-four of those died. The outbreak also put the FDA in the hot seat for not having a better handle on large compounders and led to Congress passing the Drug Quality and Security Act, which gives the FDA new, but limited, powers to oversee compounding pharmacies.
- read the DOJ release
- here's the consent decree
- get more from the FDA