FDA not sold on pharmacy compounding bill

The Obama administration has some reservations about legislation that would expand federal authority over pharmacies that mix drugs.

The Drug Quality and Security Act, which is likely to come up for a vote in the Senate in coming weeks, is “a step,” Food and Drug Administration (FDA) Commissioner Margaret Hamburg said on Tuesday. But it doesn’t go all the way.  

“I don’t think it’s going to be as comprehensive as we initially had hoped,” she said at an event sponsored by Bloomberg Government.


“Believe me, it’s not that FDA is looking for a whole lot of new responsibilities, but when there is a health and safety problem like this where we think that we have the expertise and where clearly there should be national standards, we do believe that we should be given the authority that we need,” she said.

The bill was unveiled by House and Senate lawmakers in September, as a negotiated solution to outline which agencies have authority over various compound pharmacy clinics, where batches of drugs are mixed to create medications for individual patients.

It would give the FDA power to regulate large compounding facilities but leave smaller plants to be overseen by state boards of pharmacy.

Hamburg added that she hoped the upcoming Senate vote “will make a difference.”

The bill passed the House by a voice vote in late September.

Calls for new oversight of the pharmacies emerged after a large compound pharmacy based in Massachusetts, the New England Compounding Center, distributed tainted steroid injections that led to an outbreak of fungal meningitis. More than 750 cases were reported and 64 people were killed in the outbreak.

“That was the worst outbreak of its kind, but there have been problems with compounding for a very long time,” Hamburg said on Tuesday.