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Congress OK’s stiffening drug compounding rules

The New England Compounding Center in Framingham, Mass., shut down after being implicated last year in a meningitis outbreak from one of its steroid injections.
The New England Compounding Center in Framingham, Mass., shut down after being implicated last year in a meningitis outbreak from one of its steroid injections.Associated Press/file 2012

WASHINGTON — Congress took a step Monday toward increasing federal oversight of compounding pharmacies that custom mix medications in bulk, a year after a meningitis outbreak from contaminated steroid pain injections killed 64 people and sickened hundreds.

The Senate approved the bill by voice vote, sending it to the White House, where President Obama is expected to sign it. The legislation also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies, first through serial numbers on bottles and later through electronic codes. The House passed it in September.

More than 750 people were sickened by last year’s outbreak of deadly fungal meningitis and many continue to suffer debilitating pain and nerve damage. The sickness was eventually traced to a now-closed pharmacy in Framingham, Mass., the New England Compounding Center, where inspectors found mold, and other unsterile conditions. The company shipped more than 17,600 doses of the implicated steroid injection to 23 states.

Oversight of such large-volume compounders has been murky. Pharmacies that fill individual prescriptions from a doctor or another health professional are typically regulated by state boards, but the Food and Drug Administration regulates manufacturers of medicines. The compromise bill gives the FDA authority to inspect and close down large-volume compounders, but it doesn’t require the pharmacies to register with the FDA, as prescription drug manufacturers must do.


The bill attempts to sort out the legal gray area that allowed the Massachusetts pharmacy and similar businesses to skirt both state and federal regulations. The measure clarifies the FDA’s authority over compounding pharmacies that mass-produce medications, rather than fill doctors’ prescriptions.

Under the bill, pharmacies can voluntarily register with the FDA and submit to federal quality standards and inspections. FDA officials previously said requiring compounding pharmacies to register with the agency was crucial to prevent future outbreaks.


Experts who helped craft the bill predict that nearly all large compounding pharmacies will register with the FDA as a cost of doing business.

‘‘The success of the voluntary category will depend on hospitals, clinics, and doctors choosing to buy from these FDA-registered facilities,’’ said Allan Coukell, a drug safety expert with the Pew Charitable Trusts, which lobbied to pass the bill.

Some safety advocates, however, say the bill leaves the door open for more rogue pharmacies.

FDA officials told Congress last year that regulating businesses such as NECC has been a struggle because of a ‘‘patchwork’’ of conflicting court decisions over the federal agency’s authority to deal with pharmacies.

Traditional compounding pharmacies, generally small operations that fill individual doctors’ prescriptions, will continue to be regulated by state pharmacy boards.

The FDA will retain the power to shut down any mass-production, outsourcing pharmacy, registered or not, that does not meet quality standards or engages in illegal compounding, such as making and distributing copies of manufactured drugs.