FDA Urges Compounding Pharmacies to Register

The Food and Drug Administration sent thousands of letters to hospitals calling on them to encourage compounding pharmacies to register with the agency, following a federal law that established voluntary registration.

FDA Commissioner Margaret Hamburg wrote to the hospitals and other medical providers that may buy medicines from the pharmacies, which mix drugs and until recently have been regulated relatively lightly. By registering, the pharmacies would submit to FDA inspection and other good-manufacturing requirements.

One such compounding pharmacy, New England Compounding Center in Framingham, Mass., was responsible for as many as 750 fungal meningitis cases including 64 deaths a little over a year ago. NECC, which made the steroid injections implicated in the illnesses, shut down operations after the outbreak began in October 2012.

In response to the illnesses, Congress last fall passed and President Barack Obama signed a bill setting out the voluntary registration method. Those that don't register are regulated by state pharmacy boards, and their status under federal law remains murky.

The FDA on Thursday published a list of 14 compounding pharmacies that seek to be registered as "outsourcing" compounders and fully regulated by the agency. Of the 14, FDA inspectors have previously found sterility and other problems with drugs at five, and issued warning letters to two others.

The total number of such pharmacies isn't clear, but it is widely believed there are at least hundreds of such entities. They vary from strictly local operations that mix medicines only by prescription to large multistate entities that sell thousands of doses annually.

In her letter to hospitals, Dr. Hamburg wrote to encourage them to "consider requiring compounders from which you purchase compounded sterile drugs...to register with the Food and Drug Administration as outsourcing facilities."

Some government officials with expertise on compounding pharmacies have expressed concern that the new law's voluntary provisions are too weak to have much impact in improving the sterility of compounded drugs.

Dr. Hamburg also wrote to state officials in all 50 states, urging them to persuade compounders that are based outside their states but sell drugs in their states to consider registering with the FDA.

Alan Coukell, who oversees medical programs at the Pew Charitable Trusts, said the fact that 14 pharmacies are seeking FDA regulation is a good sign, because "we're just at the beginning of this registration process."

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