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 or 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 J. 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, recordkeeping 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 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 doctors’ 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 have grown so large that they resemble manufacturing-style operations, producing tens of thousands of doses and shipping them across state lines, often without individual prescriptions.
The FDA rarely inspects the facilities, unless the agency is responding to a complaint or a request from state authorities. State pharmacy boards are the primary regulators, but their oversight and expertise is uneven.
About a dozen states were considering legislation that would require stricter licensing requirements for compounders. Maryland and Virginia have passed bills requiring greater scrutiny of compounders that make sterile drugs.
The Markey report is based on information collected from states last month.
Among the other findings:
●The majority of states allow any pharmacy to compound without a specific compounding license or permit. Forty-seven states and the District of Columbia were unable to provide an exact number of pharmacies that are authorized to compound. Only Missouri and Mississippi require a license for basic drug compounding.
Three states — Arkansas, Maine and Oregon — ask that pharmacies indicate on their initial license application whether they plan to engage in compounding activities.
●None of the states said they track the volume of medications made by compounders or whether pharmacies sell compounded drugs across state lines.
●Thirty-seven state boards of pharmacy do not systematically track which pharmacies make sterile products. Among the 13 states that do are California, Massachusetts and New Jersey.
●When issues arise with pharmacies in other states, state boards do not consistently inform each other or the FDA.
As a result, a state may discover a serious problem with the drugs produced by a pharmacy in another state, take action to stop that pharmacy from shipping drugs into its state, but never notify the home state or any other state about the safety problem.
To address this lack of information, the Iowa pharmacy board is inspecting more than 600 out-of-state pharmacies that ship medications into Iowa, including compounders. The inspections have led to charges against five compounding pharmacies. The board is accusing the companies of failing to comply with regulations that require compounders to have prescriptions for specific patients, among other violations.
Carmen Catizone, executive director of the National Association of Boards of Pharmacy (NABP), which represents the state regulators and is helping Iowa with its inspections, said the report will help efforts underway to strengthen state oversight.
“Most of what they found we’re already pushing the states to do,” he said. “But we welcome any time we can get some help from Congress to identify these issues.”
The NABP is putting together an electronic database accessible to all state pharmacy boards that would share detailed information about every pharmacy, including the states where it is licensed, its products, and any disciplinary action by any state, Catizone said. He hopes to have it ready for the states by the end of the month and accessible to the public by the end of the summer.
Aaron Davis and Magda Jean-Louis contributed to this report.