What New Bulk Substance Rules Mean For The Drug Industry

Law360, New York (March 28, 2017, 4:48 PM EDT) -- The spotlight on compounding pharmacy safety shows no signs of fading following a 2012 fungal meningitis outbreak stemming from tainted spinal steroids that killed more than 60 people and sickened hundreds more. The legal fallout from drugs produced at the New England Compounding Center’s Framingham, Massachusetts, facility has been described as the biggest criminal case ever brought in the U.S. over contaminated medicine.

The industry is still subject to ongoing regulatory updates compounding pharmacies must monitor, including changes in the U.S. Food and Drug Administration inspection methods and the recently proposed rule adding new bulk drug substances that can be used...

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