FDA preps for expanded drug oversight

The Food and Drug Administration (FDA) is getting ready to increase its powers to oversee major drug compounding centers.

On Monday, the FDA unveiled draft guidance for how large pharmacies can register as “outsourcers” and submit information about their products.


The effort is the first stage of implementation for the Drug Quality and Security Act, which President Obama signed into law last week.

The bill allows large drug compounding plants, which mix drug ingredients to make a custom blend of medicine, to register as an “outsourcing facilities” and be subject to FDA oversight. Those facilities will be inspected by the FDA and must meet a variety of conditions, but will be exempt from some approval rules.

“Today’s news really is an important step to having stronger drug quality and security laws so that Americans can have more confidence in the safety of the medicines they take,” FDA Commissioner Margaret Hamburg said.

Dangers posed by compounding facilities emerged last year, when an outbreak of fungal meningitis linked to the Massachusetts-based New England Compounding Center killed 64 people.

That outbreak helped lead to broad support for the Drug Quality and Security Act, which passed through the Senate on a voice-vote in November. The measure passed the House on a voice-vote in September.

The FDA had hoped for more authority from the bill.


Jane Axelrad, the associate director for policy at the FDA's drug evaluation center, said that the agency won’t be able to track compounding pharmacies that don’t choose to register.

“We can say that it will be difficult for us to identify a compounding pharmacy that chose not to register as outsourcers and that try to hide out in the category of traditional compounders,” she said. “In those cases we won’t be able to do proactive inspections of them. We’ll have to wait until we hear about them through either an adverse quality or report complaint.”

Hamburg added that the law “doesn’t provide the FDA with all the additional authorities we sought,” but is “definitely progress.”

Along with the guidance for pharmacists, the FDA is also releasing a formal notice that it is working on a list of drugs that “present demonstrable difficulties for compounding.”  The agency is asking the public to identify possible candidates for the list of drugs.