WASHINGTON – State authorities who are supposed to oversee the type of specialized pharmacy at the heart of last fall’s deadly meningitis outbreak lack the most basic information about the companies they are supposed to regulate, according to a congressional report to be released Monday.

State boards of pharmacy generally don’t know which pharmacies in their state engage in compounding, the custom mixing of medications for individual patients. Nor do they know how much medication they make, how much of it is sterile and whether any products are sold across state lines. Only two states, Mississippi and Missouri, routinely track the number of compounding pharmacies in their states.

The report, by Rep. Edward Markey, D-Mass., follows up on a state-by-state examination last fall into safety issues raised when thousands of vials of steroid shots were sent to doctors’ offices and clinics in 23 states by the New England Compounding Center (NECC), based in Framingham, Mass. Some of the vials were contaminated, and the outbreak killed 53 people and sickened 680 others.

The report’s findings include state-by-state information on inspections, record-keeping and other aspects of compounding oversight. The information further demonstrates that states do not have the ability to effectively inspect, track or police activities within states or across state lines, Markey said.

“In states from coast to coast, compounding pharmacies are going untracked, unregulated and under-inspected, exposing patients everywhere to tainted drugs, disease and death,” he said in a statement.

Markey and many other Democrats in Congress support legislation to give the Food and Drug Administration more authority over compounders. That topic is likely to be a focus Tuesday during a scheduled hearing of a House Energy and Commerce subcommittee.

Republicans are expected to question FDA Commissioner Margaret Hamburg about why the agency didn’t take more forceful action against the NECC before the outbreak. Democrats on the panel want executives of the International Academy of Compounding Pharmacists, a major industry group, to testify about their two decades of lobbying Congress to limit FDA authority over compounders.

Last week, FDA officials released initial results of a targeted inspection of 30 compounding pharmacies that mix sterile drugs, considered the most high risk because any breakdown in the process can result in contamination. Federal inspectors found dozens of potentially dangerous safety problems, including unidentified black particles in vials of sterile solution, rust and mold in “clean rooms,” and workers wearing torn gloves.

Hospitals, clinics and doctor’s offices rely on a wide array of medications made by compounding pharmacies, including antibiotics, painkillers, and labor and delivery drugs, as well as medication for pets.

Sometimes compounders start with raw materials. Sometimes they repackage finished drugs into different forms and concentrations.

But unlike drugs made by pharmaceutical companies, compounded drugs are not FDA-approved. Compounders do not have to meet the same standards as drug companies, even though some are extremely large.

 

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