(Updates with Enzi in fourth paragraph, Roberts in sixth.)
Nov. 15 (Bloomberg) -- 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.
Congress is investigating the oversight of compounding pharmacies that mix drugs on a large scale in anticipation of prescriptions, rather than adhering to their traditional role of responding to individual doctor’s orders. Lawmakers said they have received more than 10,000 pages of documents showing that the company at the center of this year’s U.S. meningitis outbreak, New England Compounding Pharmacy Inc., had a history of not complying with state and federal law.
“This case represents a catastrophic failure of regulatory agencies,” Senator Michael Enzi, a Republican from Wyoming, said at a hearing of the Senate’s health committee.
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