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Lawmakers: Cure for safety concerns is new regulation

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Safety problems at a Massachusetts compounding pharmacy could lead to new regulations here in New Jersey.

In October, a fungal meningitis outbreak linked to steroid injections prepared at the New England Compounding Center killed dozens and sickened hundreds in 19 states; as of Dec. 1, New Jersey had 37 cases.

Massachusetts responded by closing the center and toughening regulations governing compounding pharmacies. Now, New Jersey lawmakers are proposing action here.

State Sen. Jeff Van Drew (D-Cape May Court House) is co-sponsoring a bill with Sen. Kevin O'Toole (R-Wayne) to require compounding pharmacies to gain accreditation from the Pharmacy Compounding Accreditation Board, a clearinghouse for safe pharmacy practices. An identical bill was introduced in the Assembly by Assemblyman Herb Conaway Jr. (D-Delran), a medical doctor.

Van Drew said the long-term solution for compounding pharmacy safety is for the federal government to enact new regulations. But he said it's not clear when Congress will act, "so we thought, at least in New Jersey, we could set a standard."

Compounding pharmacies prepare customized medications for patients, who may require a smaller dosage to safely take the drug, or who might be allergic to one of its components.

Van Drew said he was first drawn to the issue when a constituent contacted him about her husband, who received one of the tainted injections. When he investigated, Van Drew found the compounding pharmacy industry isn't regulated by the Food and Drug Administration, even though larger compounding pharmacies more closely resemble drug manufacturers than local drug stores.

Kate Greenwood, a research fellow and lecturer in law at Seton Hall Law School, said the federal Food and Drug Administration's jurisdiction over compounding pharmacies has been a "hotly disputed question." She believes the FDA's enabling legislation — the Food, Drug and Cosmetic Act — allows the FDA to regulate compounding pharmacies like the one in Massachusetts.

"Legally, they have jurisdiction over compounding pharmacies that have crossed the line from compounding to manufacturing," she said.

But Greenwood said the issue has been muddied by a mix of sometimes contradictory court rulings. For instance, a 1997 revision of the Food, Drug and Cosmetic Act clarified the FDA's jurisdiction, but was later struck down due to a provision restricting advertising. Since then, federal circuit courts have disagreed on whether the non-advertising parts of the law still stand; the FDA, meanwhile, has left regulation to the states.

Another problem is the wide definition of compounding pharmacies. The label could mean a local pharmacist mixing a better-tasting version of a drug for a child, but it also includes large manufacturers, like the New England Compounding Center that ship drugs across the country.

Large or small, compounding pharmacies in New Jersey are only supposed to compound if they get a prescription, according to Neal Buccino, a spokesman for the Division of Consumer Affairs, which oversees the state's Board of Pharmacy.

Massachusetts has a similar requirement, but it was ignored by the New England Compounding Center, according to a preliminary report by that state's Department of Public Health. The report found the center wouldn't wait for prescriptions, but instead sent shipments to health care facilities, along with names of potential patients.

Greenwood said interstate shipment of compounded drugs heightens the danger.

"The problem is that compounding pharmacies will go to the state with the most lax regulation or the most lax enforcement, because the industry is now shipping interstate," she said.

In an e-mail, Buccino said 47 New Jersey pharmacies are licensed to perform sterile compounding, in addition to a number of hospitals. Those pharmacies are required to abide by the standards of the U.S. Pharmacopeial Convention, and are subject to unannounced inspections by the Division of Consumer Affairs, he said. The office has increased the frequency of inspections in the wake of the Massachusetts case, and is also reviewing its inspection protocol, he added.

Currently, only six New Jersey pharmacies are accredited by the Pharmacy Compounding Accreditation Board, which performs on-site surveys and ensures staff, equipment and ingredients are up to par. Joe Cabaleiro, the board's executive director, said New Jersey would be the first state to require his organization's seal of approval.

"Our board has asked us to not get involved in legislation" by promoting it, he said, "but certainly we would respond to New Jersey's needs, if they were to enact it."

Van Drew said he thinks PCAB's accreditation system would be a good way to create accountability without creating an extra layer of bureaucracy.

"There are so many challenges before us already that I'm also trying to think out of the box and look at ways of not overwhelming state government with responsibilities they might not otherwise have," he said. But he also called this "the beginning of a process," and he said he's willing to listen to alternate proposals.

David Ball, a spokesman for the International Academy of Compounding Pharmacists, said the group was a co-founder of PCAB, and said it already "strongly encourages" members to gain accreditation, though he noted that PCAB isn't the only accrediting board.

"So mandating one particular accreditation could be unfair to those who have received another, similar accreditation," he said. "We welcome the state of New Jersey's review of its regulation, however, and will provide whatever information or assistance is requested."

E-mail to: jaredk@njbiz.com

On Twitter: @jaredkaltwasser

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