A U.S. Senate committee on Wednesday passed bipartisan legislation that would fundamentally change how large-scale pharmacy compounding is practiced in this country.
Also Wednesday, the Senate’s Health, Education, Labor and Pensions Committee issued a report showing that poor compounding practices have persisted even since last fall, when a meningitis outbreak linked to contaminated steroid injections killed 55 people and sickened about 700.
Sen. Pat Roberts of Kansas urged senators to support the bill, noting that the report showed “the status quo is unacceptable.”
“Saying that the current law is satisfactory or preferable to anything we might do is nonsense,” Roberts said. “Fifty-five people have died.”
The compounding bill now goes to the Senate floor for consideration in June or July.
The bill is the first piece of federal legislation to require stricter regulation of compounding since Kansas City pharmacist Robert Courtney pleaded guilty a decade ago, admitting that he had diluted thousands of doses of chemotherapy medication.
The Kansas City Star first exposed concerns about the safety of compounded drugs in a 2002 series.
Compounding is a traditional part of pharmacy practice in which pharmacists create customized medications from scratch, but without having to meet the same safety and quality standards that large drug manufacturers must follow.
The new law would clarify that the Food and Drug Administration is responsible for enforcing safety and manufacturing standards for large compounders, such as the one in Massachusetts that produced contaminated steroid injections that led to last fall’s meningitis outbreak.
Traditional compounding in smaller settings, such as neighborhood pharmacies, would continue to be regulated by state boards.
But as Wednesday’s committee report suggested, compounding manufacturers, which produce large amounts of drugs without prescriptions and then ship them across state lines, still need attention.
Inspectors found that at least 48 companies produced and sold drugs that were contaminated, were compounded in unsafe conditions or otherwise broke state licensing rules. State pharmacy boards have ordered 11 compounders to stop producing some or all drugs, while 10 compounders have issued national recalls because of contamination concerns.
A nurse in March spotted fungus floating in a vial of compounded intravenous medication, prompting the New Jersey pharmacy board to require a recall. The next month, FDA inspectors in Florida spotted “black particles of unknown origin” floating in seven vials of an injectable steroid.
Also Wednesday, senators gave committee approval to a bill that would improve the ability of the FDA to track medications through the supply chain, from the company that made the drug to wholesale distributors to the pharmacist who dispensed it.
Sen. Barbara Mikulski of Maryland said that both the compounding and the drug tracking bills are important for the nation’s health.
“It’s bipartisan,” she said. “It’s common sense. It’s achievable. It’s affordable. It’s doable. And it meets a compelling human need.”