Tag Archives: compounding pharmacies

Senate Finalizes Drug Compounding, Tracking Legislation

Congress gave final approval this week to new legislation to strengthen Food and Drug Administration authority to oversee large pharmacy compounders of sterile injectibles and to require more comprehensive tracking of prescription drugs moving through the global supply chain. The House passed the the Drug Quality and Security Act in late September, but Senate action […]
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Congress Clarifies Drug Compounding, Tracking Policies

Public outrage over deaths from contaminated injectables produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the U.S. market, managed to lift the stalemate on Capitol Hill long enough to generate agreement on reform legislation. After months of public hearings and negotiations, Democrat and Republican leaders of the House […]
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Congress, FDA Should Consider Tech Solutions for Safer Compounding

By Niels Erik Hansen Last fall’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risk of errors inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened nearly 700 people in […]
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Compounded Drug Crisis Spotlights Regulatory Confusion

Compounded drug crisis spotlights regulatory confusion The call for stiffer FDA regulation of compounded drugs has been reignited by a national fungal meningitis outbreak. Last week, the Centers for Disease Control and Prevention (CDC) reported 7 deaths linked to contaminated vials of steroid injectables from a Massachusetts compounding operation. 91 people have been taken ill, […]
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