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August 23. 2014 10:58PM

NH restricts out-of-state compounding pharmacies

CONCORD - The state Board of Pharmacy last week voted not to renew manufacturing licenses for out-of-state compounding pharmacies that want to ship bulk products into New Hampshire.

It's the latest regulatory effort by New Hampshire officials to prevent the kind of contamination that led to a deadly fungal meningitis two years ago.

The multi-state outbreak, which caused 64 deaths and sickened 751 people, including 14 in New Hampshire, was traced to New England Compounding Center (NECC), a Massachusetts company that subsequently closed and filed for bankruptcy.

Tightened laws

Lawmakers last year passed new regulations for compounding pharmacies, including new labeling requirements and limitations on the quantities of compounded drugs that can be sent to providers.

The law also directed the pharmacy board to adopt new rules for pharmacies that do compounding, defined as the "preparation, mixing, assembling, packaging or labeling of a drug or device" as a result of a practitioner's prescription drug order or "in anticipation of a prescription drug orders based on routine ... prescribing patterns."

There are approximately 40 in-state and 153 out-of-state sterile compounding pharmacies licensed here, according to the Board of Pharmacy. The 4-2 vote last week by the board means those facilities can only make patient-specific medications.

And that sets New Hampshire in opposition to a new federal law that created a new category of compounding pharmacies called "outsourcing facilities." Under the Drug Quality and Security Act (DQSA), such facilities "may elect" to register with the Food and Drug Administration.

Robert Stout, vice president of the pharmacy board, has expressed concern that FDA guidelines call only for "risk-based inspections" of those facilities. And that, he said, creates a "loophole" that could lead to a repeat of the NECC crisis.

Stout was one of the four board members who voted to deny manufacturing licenses for compounding pharmacies. "People are under the impression that if they're a registered ... facility, they're under oversight to make sure that they're meeting the standards, when nothing could be further from the case today," he said.

Shortage concerns

The two board members who voted against denying the manufacturing licenses, Gary Merchant and John Genovese, did not return phone calls last week. But at the meeting, they expressed concern that the restrictions could lead to shortages of some compounded products.

Stout said he expects any such problems will be short-term, as providers and compounding pharmacies adjust to the new regulations.

Meanwhile, some New Hampshire hospitals are taking their own measures to ensure the safety of compounded medications.

Steven Klein is director of pharmacy at St. Joseph Hospital in Nashua. His hospital used to order certain compounded products from Ameridose - the sister company of NECC.

After the meningitis outbreak, St. Joseph officials "made the decision not to outsource anything," Klein said. "And now for the last two years, we're mixing everything ourselves."

Increased inspections

Since the NECC crisis, Klein said, the state pharmacy board has increased its inspections of compounding pharmacies here, including his hospital's operation. He said he welcomes the oversight.

Klein called the board's decision not to license the FDA's new outsourcing facilities "pretty wise."

"If you're going to approve something, you need to do your due diligence and actually inspect."

Regular visits

When St. Joseph used Ameridose products, hospital staff would visit the facility regularly to make sure it was up to standards, Klein said. He said the FDA currently doesn't have the resources to properly monitor all the compounding pharmacies around the country.

That's why he's comfortable with his hospital's decision to move all compounding in-house. "Everything we do here is for patient safety," he said.

In a media briefing about the new federal law last December, FDA officials acknowledged that the voluntary nature of the registration process for outsourcing facilities poses challenges.

Jane Axelrad, who led the agency's response to the NECC crisis, told reporters "it will be difficult for us to identify compounding pharmacies that choose not to register as outsourcers and then try to hide out in the category of traditional compounders."

Right direction

But that's going to be more difficult for companies to do here after the board's vote, Stout said last week. "This is another step in the right direction, to really tighten up a little bit of a loophole," he said.

Companies that previously were dual licensed as both pharmacies and manufacturers will be getting letters explaining the board's action. Such facilities are welcome to re-apply for licenses as nonresident compounding pharmacies, Stout said, "but then it's going to be all patient-specific."


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