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Two years after meningitis outbreak, Massachusetts passes compounding overhaul

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New regulations take effect in December

Pharmacists who compound preparations within the Commonwealth of Massachusetts and those who ship compounded preparations into the state from elsewhere must adhere to new regulations starting this December. Gov. Deval Patrick of Massachusetts signed HB 4235, which effectively overhauls the regulation of pharmaceutical compounding in the state, on July 10. Sections of the law take effect in December. The entire law takes effect June 30, 2015.

The move to tighten regulations on compounding practice in the state began after 749 fungal infections were traced back to contaminated preservative-free methylprednisolone acetate compounded at New England Compounding Center in Framingham, MA. The infections, which reached 20 states, caused 61 deaths over 8 months. The new legislation addresses safety concerns raised by the outbreak.

“This is model legislation that other states should be taking a look at,” said Christian Hartman, PharmD, MBA, FSMSO, who is Senior Director at Wolters Kluwer Health in Boston. Hartman chaired the committee of experts that Patrick convened in late 2012 to make formal recommendations for the new law. Among the most significant provisions of the law are new licensing requirements and random inspections by trained agents.

New licensure requirements

Any pharmacy that compounds in the state of Massachusetts or ships compounded preparations into the state must obtain an appropriate license. Licenses include those for retail sterile compounding; retail complex nonsterile compounding; institutional sterile compounding; and out-ofstate, nonresident pharmacies.

“No matter who you are or where the product comes from, whether from inside or outside the state, it will need to meet the high-quality standards that we’ve put in place because that’s what the pharmacists and citizens of Massachusetts demand,” Hartman said.

Pharmacists must complete 20 hours of continuing education in order to renew licenses. Those involved in sterile compounding must dedicate 5 of the 20 hours to the subject. Pharmacists engaged in complex nonsterile compounding must dedicate 3 hours to the subject. Failure to meet these requirements can bring fines of up to $1,000.

Allocation of licensing fees

The law provides for most of the licensing fees to go to the state board of pharmacy to fund the implementation of the law, which includes hiring and training of inspectors.

“The board of pharmacy had a miniscule budget. If you don’t fund something, you can’t expect a high-quality service,” Hartman said. “Massachusetts greatly improved the budget and, under this law, will have specialized, trained clinicians, who will go out and inspect the pharmacies.”

Random inspections, fines

Before a retail sterile compounding pharmacy can renew its license, an inspector trained in U.S. Pharmacopeia chapters <795> and <797> will perform an unannounced inspection of the pharmacy and its sterile products.

“Inspectors will know <797> to a level of detail that they did not in the past,” said David Johnson, Executive Vice President of the Massachusetts Pharmacists Association. “Now everyone is on the same page. They are well trained, they know <797> inside and out, and that will be a help to those that want to do it right.”

The law gives inspectors the authority to fine pharmacies for violations or, in the case of violations that endanger the public, suspend the pharmacy’s license pending a hearing. Pharmacies whose licenses are suspended will have a hearing no more than 7 days later.

“We are very pleased that the board will now schedule a hearing within 7 days, and that the inspectors will now be more qualified to make a fair determination,” Johnson said.

Complete overhaul

The state Board of Registration in Pharmacy will also better reflect the expertise needed to govern the compounding industry. It will comprise 13 members, 8 of whom will be pharmacists from various practice settings with 7 consecutive years of practice in Massachusetts.

“I would certainly view this as an overhaul. We did not just look at the compounding industry,” Hartman said. “We looked at budgets, the composition of the board of pharmacy, their training, and their authority.” The new law reflects changes in all of these areas.

The new regulations will be felt in daily practice, but this is not negative, Hartman said. “Any organization, any pharmacy, needs to continuously evaluate and improve the way they provide the safest care for patients.”

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