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More Drug Shortages in Fungal Meningitis Aftermath

Compounding Pharmacy Safety continued...

Allen J. Vaida, PharmD, executive vice president of the ISMP, notes that compounding pharmacies are regulated by state boards of pharmacy. Those that also register as drug manufacturers, like Ameridose, are regulated by the FDA and, if they make controlled substances, by the Drug Enforcement Administration (DEA).

Many state boards of pharmacy require compounders to adhere to strict standards set by the U.S. Pharmacopeial Convention, a nonprofit scientific organization. But some do not, and states vary in how well they enforce these standards.

"With the advent of some of these compounding pharmacies getting more into the manufacturing realm -- actually making batches of pharmaceuticals, not specific patient prescriptions as is their traditional role -- they have more or less fallen through the cracks," Vaida says. "Issues now coming to light suggest there may not have been enough oversight. State boards are not equipped to do it, and the FDA is not equipped to do it on a mass basis."

Are New Laws Needed?

Drug shortages happen for many reasons. More than half occur when something goes wrong during commercial drug manufacture.

"When you're talking about a drug being sterile, you have to be 100% right, not 99% right," says Hill. "So manufacturers, if they identify a problem, they shut down the production line. And depending on how much of a drug they make, or if they are the only supplier, there is a shortage."

Drugmakers haven't always been quick to tell the FDA about such problems. That changed in October 2011, when President Obama issued an executive order requiring companies to immediately report production issues involving life-supporting drugs to the FDA.

With this kind of head start, the FDA can help relieve shortages by looking for other manufacturers who can make the drug. Or it can speed pending approvals for companies that already have asked to make the drug. In a news release, FDA Commissioner Margaret Hamburg, MD, says the FDA already has prevented 145 drug shortages this year.

Moreover, the July 2012 Food and Drug Administration Safety and Innovation Act established user fees for generic drugmakers that will allow the FDA to speed the approval process. It also expands the FDA's authority to inspect drug-making facilities.

But new legislation proposed by Rep. Edward Markey (D-Mass.) would vastly restrict what compounding pharmacies can manufacture and greatly increase FDA oversight.

Vaida says he's not sure additional legislation is needed.

"We haven't followed through or monitored compounding pharmacies as well as we could," he says. "Something has to come out of this [fungal meningitis outbreak]. Compounding pharmacies are going to have to be inspected, either by state boards -- given better resources and insisting on stricter requirements they have to follow -- or by the FDA if they are into drug manufacturing."

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