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U.S. Senate backs bill to regulate bulk drug compounding

WASHINGTON (Reuters) - The U.S. Senate on Monday approved a bill designed to prevent the type of quality control problems that led last year to a deadly outbreak of fungal meningitis traced to a tainted pharmaceutical mixed by a Massachusetts pharmacy.

The bill, known as the Drug Quality and Security Act, clarifies the law regarding drug compounding and creates a new category of compounding pharmacies known as "outsourcing facilities."

It also creates a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medications into the drug supply.

The bill was passed earlier by the House of Representatives and is expected to be signed into law by President Barack Obama within days.

Traditionally, pharmacists who compound medications mix tailored doses for individual patients in response to a specific prescription. Over the last decade the practice has mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.

The new law creates a category of compounding outsourcing facilities that will be able to sell to hospitals in bulk. The facility can choose to register with the U.S. Food and Drug Administration (FDA), in which case it will undergo regular inspections and be subject to tighter quality controls.

Some pharmacies may choose not to register with the FDA. Lawmakers are betting hospitals will choose to buy from companies that are regulated by the FDA.

"For the first time there is a category of compounding pharmacies that will be regularly inspected by the FDA, which should provide peace of mind to the hospitals purchasing these drugs," said Allan Coukell, who oversees medical programs at The Pew Charitable Trusts.

The bill is designed to provide greater oversight over pharmacies such as the New England Compounding Center in Framingham, Massachusetts, which was at the heart of the meningitis outbreak that killed more than 50 people.

Although they will be regulated by the FDA the outsourcing facilities will be exempt from the full spectrum of rules that apply to traditional pharmaceutical companies. Traditional pharmacies will continue to be regulated by state boards of pharmacy.

The bill will also create national standards to track and trace drugs amid growing concerns over counterfeit drugs. Last year, fake vials of Roche Holding AG's cancer drug Avastin appeared in the United States from Britain, where it was purchased from a Turkish wholesaler.

In the United States, dozens of states have some type of regulation designed to track a drug's pedigree, but the rules are inconsistent. This bill is designed to resolve the current patchwork of federal regulation by applying a uniform standard nationwide.

(Additional reporting by Ros Krasny in Washington; Editing by Gerald E. McCormick, Dan Grebler and Chris Reese)

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