WASHINGTON—A bill to regulate so-called compounding pharmacies is headed to the president for his expected signature, a little more than a year after tainted steroid injections from one such enterprise caused more than 750 cases of spinal meningitis.
Compounding pharmacies mix drugs for patients, but some mix drugs for thousands of patients and perform more like drug makers than corner drugstores.
Compounding pharmacies grabbed headlines last fall when it was learned that the New England Compounding Center of Framingham, Mass., sold thousands of doses of the steroid methylprednisolone acetate tainted by fungus, the Food and Drug Administration found. The steroid shots led to fungal meningitis that caused 64 deaths and sickened hundreds of people in 20 states. The center suspended operations in October 2012.
The legislation, which cleared the Senate on a voice vote on Monday and already passed in the House of Representatives, allows compounding pharmacies to declare themselves to be manufacturers, or, as the bill describes them, "outsourcers." By doing this, the pharmacies would voluntarily place themselves under full FDA regulation, meaning the agency will perform inspections and possibly find problems before they cause illness and death.
But the legislation doesn't draw a clear line delineating which, if any, compounders must be regulated by the FDA. Those not regulated by the FDA are supposed to be monitored by state pharmacy boards.
The FDA said it is pleased that the bill creates a new pathway in which a compounder canregister as an "outsourcing facility" subject to federal quality standards and oversight. "While this bill does not provide FDA with all the additional authorities it sought related to compounding pharmacies, it provides a regulatory framework for certain compounders who register with FDA," a spokesman said.
Some government officials said the measure is too watered down to prevent future disease outbreaks like the one last year.
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