FDA to promote use of registered drug compounders under new law

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U.S. health officials are hopeful that hospitals and other healthcare providers will show sufficient preference for using drug compounders that sign up for regulatory scrutiny under a new law that potentially risky medicines will no longer be supplied by unregistered compounding pharmacies.

The law was spurred by the deadly outbreak of fungal meningitis last year that killed 64 Americans and sickened more than 700 due to contaminated injections made and shipped by a Massachusetts drug compounder that was not under the oversight of the Food and Drug Administration.

FDA officials on Monday said the law, recently signed by President Barack Obama, gives it new muscle to oversee drug compounders by creating a pathway for them to officially register with the agency as an drug outsourcer.

Prior to the meningitis outbreak, drug compounding had been a long-used but little-known practice in which pharmacists traditionally alter or recombine drugs to meet the needs of specific patients with a doctor's prescription. But many had grown so large that they became more like manufacturers and distributors.

They had been primarily overseen by state authorities that are often ill-equipped for the job.

"We do appreciate that this new law gives us greater clarity and creates this new outsourcing facility category," FDA Commissioner Margaret Hamburg told reporters on a conference call on Monday.

Hamburg said she would liked to have seen Congress give the FDA even greater authority to regulate compounding pharmacies, but added, "We believe we can achieve a great deal with this new law."

Compounders that pay a fee to become registered outsourcers would be subject to FDA oversight, inspections of facilities and products and would be required to follow good manufacturing practices laid out by the agency.

The FDA plans to post a list of all registered outsourcers on its website and will promote their use by healthcare providers.

"We certainly plan to talk to all the various stakeholders so that they can understand the benefits of FDA-reviewed products," Hamburg said.

"We hope that all the ones that are making high-risk products will be registered with us," she added. "We hope this will be the standard of practice for where providers will seek these kinds of medicines for their patients."

Drugs that need to be sterile, including those that are injected, are among those considered to be high-risk products.

Many compounders that choose not to register with the FDA as official outsourcers will remain subject to oversight by state pharmacy boards until the FDA is alerted to a specific problem.

"It will be difficult for us to identify compounding pharmacies that choose not to register with us," said Jane Axelrad, associate director for policy for the FDA's Center for Drug Evaluation and Research. "We will not be able to do proactive inspections and will have to wait until we have a complaint."

But by encouraging hospitals and medical practices to work with drug compounders that do register for regulatory oversight, the FDA hopes to have greater impact.

"The more that register, the less need there would be to buy from facilities that are not registered," Axelrad said.