Monday, April 29, 2013

Draft bill gives FDA authority over some pharmacies

The Food and Drug Administration would gain greater authority over pharmacies that compound sterile drugs and ship them across state lines under proposed legislation announced on Friday.
The proposal from a bipartisan group of U.S. senators comes in the wake of a meningitis outbreak last fall that killed 53 people and sickened more than 700. The outbreak was linked to a tainted steroid distributed by the New England Compounding Center.
The proposal would draw a distinction between traditional compounding pharmacies, which make drugs based on specific prescriptions for individual patients, and those such as NECC, which make products without prescriptions for physicians to keep for future use.
"By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak," Iowa Democrat Tom Harkin, chairman of the Senate health committee that developed the draft legislation, said in a statement.
The bill would create a new class of drugmaker that would be regulated by the FDA but would be exempt from the full raft of regulations that apply to traditional pharmaceutical companies.

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