Lab that made tainted steroid shots to get 'CSI' treatment (+video)

"In those cases you just say: 'OK, we're only going to use this drug for five days.' You limit the shelf life," she says, to prevent any microbial contaminants from going into population overdrive.

How materials were stored and how long were they in storage are two issues that investigators look into, says Edmund Elder Jr., director of the Zeeh Pharmaceutical Experiment Station at the University of Wisconsin in Madison.

According to Food and Drug Administration records, one of the agency's concerns about NECC in 2006 was that it repackaged sterile, injectable drugs – a process that exposes the sterile drug to contamination as vials are opened and the contents are transferred to syringes. The FDA warning letter also raised related storage issues.

Beyond process issues, the company also has come under scrutiny for the large amounts of drugs it produces.

"We're finding out that volume out of this pharmacy was astronomical," says Mr. Kastango says. The numbers suggest that its operation had crossed the divide between compounding to match prescriptions and out-and-out manufacturing, he adds.

The fungus involved in the NECC case can crop up in homes, soils, water supplies, or the air, says Dr. Elder, who has participated in investigations of previous incidents at compounding pharmacies. It can enter a lab on shoes, on the lab coat of someone outside taking a break and not changing into clean lab garb after returning, or though air ducts, adds Mr. Kastango, pointing to past examples.

Investigators typically aim to pinpoint the pathway by which a contaminant entered the product. But they also eye a pharmacy's environmental-monitoring effort, which is supposed to check for the presence of potential contaminant organisms within the facility. Such efforts are included in a detailed set of international standards, which is the foundation for federal regulations as well as regulations in many states. The standards also call for periodic checks of employees – swab-testing hands and lab suits, for instance.

Inside a facility, some small amount of contamination may be present, specialists say. The key is to make sure minimal contamination remains minimal.

Reflecting on incidents he's helped investigate, Elder draws an analogy to a catastrophic airliner crash: "You can have single things go wrong in any flight, and the plane still lands in the end. But if you have multiple things go wrong, and the pilots involved don't react appropriately, we see a catastrophic event."

"It's not necessarily one thing that went wrong, but a number of different things that went wrong that sometimes have built up over time," he adds."Someone took a shortcut, nothing happened, so that becomes their normal way of operating."

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