Inside its sprawling red brick offices, New England Compounding Center engaged in the most hazardous type of pharmacy drug making. The company bought unsterilized powders and turned them into liquid steroids and other medicine supposedly pristine enough to inject into a patient.
It’s called “high-risk compounding,” and doing this safely, industry specialists say, requires elaborate and expensive manufacturing processes, sensitive tests for sterility and potency, and exacting attention to detail.
At the center of the federal and state investigation into New England Compounding, whose steroids were contaminated with a fungus that led to an outbreak of meningitis that has killed 24 people nationally, is whether the company violated these procedures.
Injectable drugs made from raw ingredients are so susceptible to contamination that in 2009 the Food and Drug Administration highlighted them on a list of medicines that are especially risky for pharmacies to prepare.
The agency offered that list as “guidance to industry,’’ but did not have authority to enforce rules to ensure that pharmacies follow proper practices, FDA spokesman Steven Immergut said last week.
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