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Bacteria found in more drugs from Mass. pharmacy

Duane Marsteller, The Tennessean
The door of the New England Compounding Center in Framingham, Mass., is seen Thursday after Rep. Ed Markey, D-Mass., had a news conference outlining a plan to more closely regulate compounding pharmacies.
  • Previous contaminations found New England Compounding Center drugs were fungal
  • This time two drugs had strains of bacteria found in soil
  • Tests are still being conducted to see if those medicines also have fungal contamination

Federal investigators say they found contamination — this time, bacterial — in two more drugs produced by a Massachusetts specialty pharmacy whose fungus-tainted steroid shots have been linked to a massive meningitis outbreak.

Tests found several different strains of bacillus in a steroid and a medicine used in heart surgery that were produced by New England Compounding Center, the federal Food and Drug Administration and U.S. Centers for Disease Control and Prevention said Thursday.

The bacteria are commonly found in soil. The CDC said it has not received any reports of infections from the medications.

The bacteria were in three lots of the steroid betamethasone and one lot of cardioplegia solution, which is used to slow or stop the heart during surgery.

The CDC said it is still testing those lots for fungal contamination similar to those found in three lots of methylprednisolone acetate, another steroid, made by NECC. Those lots are considered the likely source of a fungal meningitis outbreak that so far has sickened 386 people and killed 28 in 19 states.

The latest test results "reinforce the FDA's concern about the lack of sterility in products produced at NECC's compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products," the agency said.

Because operations like New England Compounding, which produce large amounts of compounded drugs, fall through federal regulatory cracks and often are subject only to state rules, a Massachusetts lawmaker is proposing to require that big companies register with the FDA and be subject to the same requirements as major pharmaceutical companies.

"Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory," said Rep. Edward Markey, D-Mass., adding that his bill would end "this regulatory black hole by giving the FDA new clear authority to protect patients."

A bill similar to Markey's was proposed in 2007, but it never passed.

New England Compounding Center, based in Framingham, Mass., voluntarily ceased operations and recalled all of its products last month.

(Contributing: Walter F. Roche Jr., The Tennessean)

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