A Texas compounding pharmacy has agreed in federal court not to resume making sterile drugs until it complies with the Food, Drug and Cosmetic Act, which deals with drug safety, and also receives FDA approval. The ruling follows reports that 17 people were sickened after receiving infusions of its products.
The agreement follows other instances in recent months involving the safety of sterile drugs made by compounding pharmacies. In December, it was announced that 14 people were indicted—including two pharmacists on charges of second-degree murder—over a deadly 2012 fungal meningitis outbreak linked to a tainted steroid produced by the New England Compounding Center in Framingham, Mass.
In January, HHS' Office of Inspector General released a report showing significant gaps in ensuring the safety of compounded drugs given in hospitals, and making a number of recommendations.
The pharmacy, Specialty Compounding, denied that it's responsible for bacterial infections in 17 patients at two Texas hospitals in 2013. The bacteria in question was never found in the company's facility, said David Ball, a company spokesman. The pharmacy did, however, voluntarily stop manufacturing sterile drugs after the incident and issued a recall.
Since then, the pharmacy has invested $2.5 million in improvements, including a new clean room, new policies and procedures, and experts, Ball said.
The company's owners must show they've implemented corrective actions, and the Food and Drug Administration must then give the pharmacy written approval saying it is in compliance with the terms of the permanent injunction issued in U.S. District Court in Austin, Texas, this week before it may resume manufacturing sterile drugs, according to the Justice Department.
Ball said Specialty now believes it's in compliance, and awaits an FDA inspection.
“They've made a major investment in the facility,” Ball said. “They do plan to re-open in the near future.”
The Justice Department brought the case against Specialty at the request of the FDA after the FDA received reports that 17 patients had developed bacterial infections caused by Rhodococcus equi after getting infusions of calcium gluconate made by Specialty.
The FDA inspected the Cedar Park, Texas, pharmacy shortly after the patients were sickened and found unsanitary conditions and violations of current good-manufacturing-practice requirements for drug products, according to the Justice Department.
The FDA found the pharmacy was distributing some its drugs without getting valid prescriptions for individual patients and was introducing into interstate commerce misbranded and unapproved new drugs. Also, bacterial contamination was found in a sample of one of the company's drugs collected by the FDA.
Specialty made both sterile and nonsterile drugs, which it distributed to hospitals, surgery centers and health clinics in Texas and throughout the U.S.
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