The Food and Drug Administration is beefing up its oversight of pharmacies that create custom drugs in response to a 2012 meningitis outbreak linked to tainted medicines that left 64 people dead.
The FDA released regulations Tuesday for compounding pharmacies, which work with physicians to create specific drugs for individual patients, rather than mass producing pharmaceuticals for the public.
The agency has now set manufacturing standards, updated its list of drugs that are too risky to be altered and detailed the actions it can take to punish companies that don’t follow their regulations.
Compounding pharmacies that don’t follow the FDA’s rules can have their products seized and face criminal prosecution.
The agency said its rules give it broad latitude to act if it suspects a problem.
“Generally, FDA expects to employ a risk-based enforcement approach with respect to violative compounded drugs,” said the agency. “However, FDA emphasizes that it need not identify a particular safety problem before pursuing enforcement action.”
The agency’s expanded regulatory authority comes from the Drug Quality and Security Act passed by Congress last year after a fungal meningitis outbreak linked to a Massachusetts compounding pharmacy resulted in 751 reported infections across 20 states.
Sixty-four people are thought to have died from tainted steroid injections made at the New England Compounding Center in Framingham, Mass.
Unlike traditional pharmaceutical companies, compounding pharmacies have long avoided FDA scrutiny.
However, after the 2012 outbreak federal investigators discovered that a number of compounding pharmacies across the country were mass producing drugs and distributing them across states, leading lawmakers to expand the FDA’s authority over them.