U.S. Senate backs bill to regulate big drug compounders

Reuters

WASHINGTON, Nov 18 (Reuters) - The U.S. Senate on Mondayapproved a bill designed to prevent the type of quality controlproblems that lead last year to a deadly outbreak of fungalmeningitis that was traced to a tainted pharmaceutical mixed bya Massachusetts pharmacy.

The bill, known as the Drug Quality and Security Act, will give the Food and Drug Administration greater authority toregulate companies that compound sterile drugs and ship themacross state lines.

The bill was passed earlier by the House of Representativesand is expected to be signed into law by President Barack Obamawithin days. It would also create a national set of standards totrack pharmaceuticals through the distribution chain to helpthwart the introduction of fake medications into the drugsupply.

Traditionally, pharmacists who compound medications mixtailored doses for individual patients in response to a specificprescription. Over the last decade the practice has mushroomed,with some pharmacies selling thousands of doses of regularlyused mixtures without prescriptions for physicians to keep forfuture use.

The legislation draws a distinction between traditionalcompounding pharmacies, which will continue to be regulated bystate boards of pharmacy, and large-scale compounding pharmaciessuch as the New England Compounding Center in Framingham,Massachusetts, which was at the heart of the meningitis outbreakthat killed more than 50 people.

These larger organizations, to be known as "outsourcingfacilities," will be regulated by the FDA but be exempt from thefull spectrum of regulations that apply to traditionalpharmaceutical companies.

The bill will also create national standards to track andtrace drugs amid growing concerns over counterfeit drugs. Lastyear, fake vials of Roche Holding AG's cancer drugAvastin appeared in the United States from Britain, where it waspurchased from a Turkish wholesaler.

In the United States, dozens of states have some type ofregulation designed to track a drug's pedigree, but the rulesare inconsistent. This bill is designed to resolve the currentpatchwork of federal regulation by applying a uniform standardnationwide.

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