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Hospitals Seek to Close Gray Area for Drug Compounders

Hospital pharmacists said compounding unique versions of medicines on a large scale creates a gray area between manufacturing and supplying drugs that Congress must clear up following the meningitis outbreak.

“The distinction between traditional pharmacy compounding and manufacturing appears to be a regulatory gray area,” Kasey Thompson, vice president of policy at the American Society of Health-System Pharmacists, said today in prepared testimony for a Senate committee hearing in Washington. “There may be a need for a special category” of oversight that falls between compounding and manufacturing, she said.