Congress Steps Up to Regulate Compounding Pharmacies

Congress is finally getting around to reducing the risk of contaminated drugs that too often, lately, have been manufactured by compounding pharmacies. You’ll recall the deadly outbreak of meningitis and the series of infections stemming from these semi-rogue operations that so far, aren’t subject to the same regulatory scrutiny as other manufacturers of pharmaceuticals.

Compounding pharmacists used to tailor drugs and doses for individual patients with specific prescriptions, but in recent years the business has mushroomed. Some compounding pharmacies sell thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.

As widely reported last week, including on Reuters.com, U.S. House of Representatives and Senate committees have agreed on legislation to empower the FDA to regulate companies that compound sterile drugs and ship them across state lines.

The legislation also would establish a national set of standards to track pharmaceuticals through the distribution chain in the hope of catching fake medication before it enters the drug supply.

The Drug Quality and Security Act separates traditional compounding pharmacies from those such as New England Compounding Center, which was responsible for the contaminated steroid that caused the fungal meningitis outbreak, and that shipped it across state lines. Such larger organizations, to be known as “outsourcing facilities,” would be regulated by the FDA but be exempt from the full spectrum of regulations that apply to traditional pharmaceutical companies.

Traditional compounding pharmacies would continue to be regulated by state boards of pharmacy.

The legislation is expect to pass quickly through the full House and Senate.

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