Bill could tighten federal oversight of pharmaceutical compounding

Over the last 10 decade, the practice has grown much bigger, leading some to call for FDA involvement

Under the bill currently being discussed, compounding pharmacies could be subject to oversight by the FDA much like traditional drug manufacturers.
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The Food and Drug Administration could gain more wide-ranging control over large-volume compounding pharmacies under federal legislation that has gained bipartisan support in the House and Senate. The legislation was prompted by a deadly meningitis outbreak last year linked to a Massachusetts facility.

Traditionally, the practice of pharmacy compounding involves the combining of two or more drugs by a pharmacist that results in the production of medication that is tailored to special medical needs of individual patients, according to the FDA. An example of which would be the creation of a medication made without a certain dye for patients who would have an allergic reaction to it.  

However, over the last 10 years, the practice has grown much bigger, with some pharmacies selling thousands of doses of regularly-used drug compounds without prescriptions for physicians to keep for future use.

Currently, state pharmacy boards oversee pharmacies, including compounding pharmacies that mix customized medicines. However, the newly-compounded drugs, which lawmakers said accounted for around four billion prescriptions each year in the U.S., are not subject to FDA-approval.

Ilisa Bernstein, acting director of the FDA's Center for Drug Evaluation and Research, said compounding, if done improperly, could result in contamination or even produce medication that doesn't measure up in terms of strength, quality and purity.

"Because patients who use these compounded medications may have serious underlying health conditions," she said in an article on the FDA'S website. "These flawed methods pose special risks."

In testimony during a hearing before a House subcommittee in July, Kasey Thompson, the vice president of policy, planning and communications at the American Society of Health-System Pharmacists said his organization believes large compounding outsourcers should be required to be inspected by the FDA. 

"The evolution of the compounding outsourcing industry has outpaced the ability of state and federal laws to keep up, creating legal and regulatory gray areas between state and federal government," he testified. 

Under the bill currently in the Senate Committee on Health, Education, Labor, and Pensions, compounding pharmacies can register as outsourcing facilities and be subject to oversight by the FDA much like traditional drug manufacturers are monitored. Those that choose to remain traditional pharmacies would continue to be regulated primarily by state boards of pharmacy.

Iowa Sen. Tom Harkin, the chairman of that committee, said Wednesday that the bill calls for an "unprecedented tracing system that will track prescription drugs from manufacturing to distribution."

Under the new system, federal regulators would be able to track what the compounding pharmacies are making, receive reports about problems with  any of the compounded drugs, and have the authority to conduct safety inspections.

The bill was prompted by the 2012 meningitis outbreak tied to the now-shuttered New England Compounding Center in Framingham that killed at least 64 people and sickened 750 more. Inspections subsequently found unsanitary conditions at the company's facility.

Deaths and injuries linked to the New England Compounding Pharmacy have been reported in 20 states, according to the federal Centers for Disease Control and Prevention.

Sen. Lamar Alexander, R-Tenn. praised the bill, saying in a statement that it would "help prevent Tennessee families from living through another nightmare like last year's tragic meningitis outbreak." Last year's outbreak killed 16 Tennessee residents.

Al Jazeera and wire services 

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