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5 Flash Points As FDA Gets Earful On Compounding Guidance

Law360 (May 25, 2018, 8:44 PM EDT) -- The U.S. Food and Drug Administration’s move to dramatically curtail large-scale compounding of lower-cost drugs is stoking fiery debate about benefits for patient safety and possible drug shortages. 

The debate played out in dozens of letters submitted by influential lobbying groups and various drug compounders. At issue is draft guidance the FDA floated in March to explain when big compounders known as “outsourcing facilities” can make products — ostensibly for patients with special medical needs — using bulk ingredients, as opposed to costlier FDA-approved products....
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