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

WASHINGTON, Nov 18 (Reuters) - The U.S. Senate on Monday approved a bill designed to prevent the type of quality control problems that lead last year to a deadly outbreak of fungal meningitis that was traced to a tainted pharmaceutical mixed by a Massachusetts pharmacy.

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

The bill was passed earlier by the House of Representatives and is expected to be signed into law by President Barack Obama within days. It would also create a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medications into the drug supply.

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 legislation draws a distinction between traditional compounding pharmacies, which will continue to be regulated by state boards of pharmacy, and large-scale compounding 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.

These larger organizations, to be known as "outsourcing facilities," will be regulated by the FDA but be exempt from the full spectrum of regulations that apply to traditional pharmaceutical companies.

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.