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Drug Compounding: Many Considerations
The tug-of-war pitting patients against pharmaceutical companies against pharmacists selling competing compound drug mixtures to the public has lately gained greater urgency. Pharmaceuticals manufacturers contend that once their branded medications have been approved by the FDA, compounded concoctions that replicate them should not be permitted, as they are not subject to the same high safety standards and inspection requirements of the branded drugs. Consumers and pharmacists, among others, claim such arguments mask a different Big Pharma goal: the pursuit of high profits at the expense of patient access to affordable medications.
Now, a nationwide outbreak of fungal meningitis, likely caused by one component of a compounded drug, is altering the dialog. The suspect product in this instance is an injectable steroid, preservative-free methylprednisolone acetate (80mg/ml), which was produced by New England Compounding Center (NECC), in Framingham, MA. It was distributed across the country to pain clinics, which administered it to an estimated 13,000 patients. As of Oct. 9, 11 people who received these steroid injections had died of fungal meningitis, and 119 more had reportedly been sickened. Still more were anxiously waiting to see if they would develop symptoms of this non-contagious form of the disease.
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The DOJ's Corporate Enforcement Policy: One Year Later
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