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Better FDA Oversight is Needed for Prescription Safety

But one segment of the pharmaceutical industry has been carved out of the FDA inspection process. Compounding pharmacies, which create customized medications from scratch, are regulated by state boards, and sometimes not closely enough. Most are professionally run operations that serve an essential role in medicine. But as two recent incidents have proved, it is too easy for rogue drug manufacturers to exploit an oversight vacuum and jeopardize patients’ safety.

An outbreak of deadly fungal infections identified in September was traced to the New England Compounding Center in Massachusetts. Regulators said the place was operating more like a drug manufacturer than a traditional compound pharmacy, which works with physicians to produce small quantities of medications. The contaminated drugs that were mass produced by the Massachusetts firm sickened more than 700 persons and killed 58 others.

More recently, illnesses in four states have been linked to the Main Street Family Pharmacy in Tennessee. Regulators have cited the operators with multiple violations, including the discovery of spiders in the “clean room” where sterile drugs are compounded.

This risky behavior must end. Fortunately, a bipartisan group in…

Click Here to Read the Full Article.


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