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State and Nation

October 16, 2012

Dirty shoes? How did steroids get contaminated?

— NEW YORK (AP) — Was it some moldy ceiling tiles? The dusty shoes of a careless employee? Or did the contamination ride in on one of the ingredients?

There are lots of ways fungus could have gotten inside the Massachusetts compounding pharmacy whose steroid medication has been linked to a lethal outbreak of a rare fungal form of meningitis.

The outbreak has killed at least 15 people and sickened more than 200 others in 15 states. Nearly all the victims had received steroid injections for back pain.

Federal and state investigators have been tightlipped about any problems they may have seen at the New England Compounding Center or whether they have pinpointed the source of the contamination. They did disclose last week that they found fungus in more than 50 vials from the pharmacy.

Company spokesman Andrew Paven said by email that criminal investigators from the Food and Drug Administration were at the pharmacy in Framingham, Mass., on Tuesday. The visit was part of a broad federal and state investigation of the outbreak, FDA spokesman Steven Immergut said in an email.

New England Compounding has not commented on its production process or what might have gone wrong, so outside experts can only speculate. But the betting money seems to be on dirty conditions, faulty sterilizing equipment, tainted ingredients or sloppiness on the part of employees.

The drug at the center of the investigation is made without preservative, meaning there's no alcohol or other solution in it to kill germs such as a fungus. So it's very important that it be made under highly sterile conditions, experts said.

Compounding pharmacies aren't as tightly regulated as drug company plants, but they are supposed to follow certain rules: Clean the floors and other surfaces daily; monitor air in "clean rooms" where drugs are made; require employees to wear gloves and gowns; test samples from each lot.

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