Wednesday, October 2, 2013

Compounding Recalls Continue, but FDA Slow To Respond

A compounding pharmacy in Texas recalled all of its sterile products in August after 15 patients in two hospitals developed bacterial bloodstream infections linked to calcium gluconate infusions made and distributed by the compounder.

The voluntary action by Specialty Compounding, based in Cedar Park, Texas, was the latest of at least four recent national recalls involving pharmacy compounders or distributors of compounding products. Although relatively minor in comparison to last fall’s fungal meningitis crisis that left more than 60 people dead and in excess of 700 sickened in 15 states, the newest incidents have increased pressure on Congress to pass legislation giving the FDA the authority to oversee pharmacies that make and distribute bulk-quantity sterile products without specific patient prescriptions, and often across state lines.

As compounding legislation awaits further developments, Public Citizen, the Washington, D.C.-based public health advocacy group, sought to keep safety and regulatory oversight top-of-mind by issuing a critique of how the FDA handled the Specialty Compounding recall. At press time, the group charged that the FDA knew of potentially unsafe drug production practices at the Texas compounder as early as March 2013, when the agency found manufacturing issues during an inspection of the facility. And yet Specialty Compounding didn’t issue its voluntary product recall until Aug. 9, Public Citizen pointed out.

“The FDA knew there was a serious problem here, but didn’t use its existing legal authority to take prompt, aggressive action against the company,” Michael Carome, director of Public Citizen’s Health Research Group, stated in the press release. That delay, he said, “exposed patients to unnecessary risk and might have contributed to 15 people being infected.”

He asked: “What’s the purpose of inspecting a facility if you’re not going to take appropriate action when you find conditions that pose a safety threat to patients?”

The FDA was not immediately available to comment on the Public Citizen charges.

In addition to August’s Specialty Compounding recall, there have been at least three other recent recalls involving sterile compounded products:
  • Earlier in August, Nexus Pharmaceuticals of Vernon Hills, Ill., voluntarily recalled two lots of benztropine mesylate, after visible particles were discovered in product vials. According to the company, the product was manufactured by Allergy Laboratories and distributed by Nexus.
  • In July, Beacon Hill Medical Pharmacy of Michigan recalled 46 products after the FDA raised questions about their sterility.
  • Also in July, Fresenius Kabi USA recalled four lots of benztropine mesylate injection, also due to the potential presence of glass particles in the vials.

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