Tuesday, April 30, 2013


Health Canada Reviews Compounding Regulations Following Drug Scare
After reports of more than 1,000 patients receiving diluted chemotherapy treatments, Health Canada has implemented an interim solution to cover gray areas in the oversight of small compounding facilities, allowing admixing to continue under strict direction.

International Regulatory Compliance Blog--Compounding Laboratories & Pharmacies – How Safe Are Your Products?


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Will Senate fix compounding pharmacy oversight this time?


The first time most people heard of a “compounding pharmacy” was last fall, when people started dying after getting routine shots produced by one such operation in the Boston area. By early this month, the death toll stood at 53, or 50 more than the marathon bombings.

Among the dead was Douglas Wingate, 47, a Virginia account executive whose only complaint was a pinched nerve in his shoulder. He got a steroid shot and became a victim of a meningitis outbreak tied to tainted injections made by the New England Compounding Center.

More than 700 people in 20 states have been sickened, and many are still suffering.

In the aftermath of this public health disaster, Republicans and Democrats in Congress are debating two questions: Has the Food and Drug Administration failed to use its existing authority to oversee compounders such as NECC? Or does the FDA need broader powers?

The answers are yes, and yes. The FDA repeatedly dropped the ball. And the agency’s authority does need to be clarified and expanded.

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BREAKING NEWS: TN governor signs bill easing compounding--No Requirement Anymore for Patient-Specific Prescription


Gov. Bill Haslam has quietly signed into law a bill that eliminates a Tennessee requirement that pharmacists have a patient-specific prescription before dispensing a specially compounded drug.
The measure, which was backed by the Tennessee Pharmacists Association and sponsored by two legislators who are licensed pharmacists, comes in the wake of a nationwide fungal meningitis outbreak blamed on a Massachusetts drug compounding firm.
Alexia Poe, spokeswoman for the governor, said state Health Department officials worked with legislators to put in safeguards to ensure patient safety.
Those provisions include a requirement that pharmacists doing compounding filequarterly reports with the state on the volume of compounded drugs they are producing. That reporting requirement, however, does not apply to hospital pharmacies.
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How a Shadow Drug Industry Tries to Avoid Regulation

How a Shadow Drug Industry Tries to Avoid Regulation