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Pharmacy board adopts new rules

Specialty pharmacies similar to the Framingham compounding company linked to the ­national fungal meningitis outbreak will be required to report to the state the volume of medications they are making and whether they have detected contamination in their laboratories, under emergency state regulations adopted Thursday.

Later in the day, federal regulators said they found contamination in two more New England Compounding Center ­products — preservative-free ­betamethasone, a steroid used to ease back pain, and cardioplegia solution, a medication used in heart surgery.

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A fungus previously found in another steroid the company makes, preservative-free methylprednisolone acetate, is believed to have infected 386 patients with meningitis and joint infections and killed 28. The fungus has been found in two of the three lots of the drug implicated in the outbreak, and testing of the third lot is ongoing.

Massachusetts’ new rules will give the state pharmacy board enhanced powers to more quickly shut down compounding pharmacies and quarantine their products because of safety concerns.

The rules, pushed by the ­administration of Governor ­Deval Patrick and unanimously approved by the Massachusetts Board of Registration in Pharmacy, will for the first time ­allow the state to track drugs made by compounding pharmacies to determine whether they are operating more like a manufacturing facility subject to licensing by the US Food and Drug Administration.

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“The compounding industry has evolved, and in some ways it has outgrown the current regulatory framework, not just the state but the federal regulatory framework,” Patrick said Thursday. He said officials are trying to understand “what the state role is and how we have to help close that gap.”

The regulations require pharmacies to report when they are the subject of an investigation by another state or federal authority, and establish penalties for violations of the rules.

State law requires compounders to have a patient prescription for each dose of medication produced, but officials have said New England Compounding was operating like a manufacturer, mass producing medications in violation of its state license.

The FDA, which licenses drug manufacturers, said on its website Thursday that it did not yet know “the clinical significance” of the bacterial contamination found in additional New England Compounding products.

Federal health officials have not received reports of laboratory-confirmed cases of bacterial infection in patients linked to the medications from New England Compounding, the FDA said.

But the findings “reinforce the FDA’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products,’’ the agency said.

All of the company’s drugs have been recalled, and it has ceased operations.

Federal officials previously said they were investigating whether contaminated products caused fungal infections in two patients, one treated with cardioplegia and another with a different drug made by New England Compounding.

The Globe reported this week that New England Compounding sent customers a “Quality Assurance Report Card” trumpeting the cleanliness of its labs, even as internal tests showed widespread contamination.

The state’s emergency regulations will now require compounders to report contamination problems to the pharmacy board within seven business days.

“By requiring reporting, we will be able to ensure that pharmacies act quickly and appropriately to address identified contamination,” said Iyah Romm, policy director of the Bureau of Healthcare Safety and Quality.

State health officials last month said they would require the 25 compounders that produce sterile injectable medications, similar to those made by New England Compounding, to sign an affidavit attesting to compliance with all laws and regulations.

Romm said the forms were signed by all except four pharmacies that indicated they are not doing any sterile compounding at this time. The emergency regulations will now require compounders to sign such affidavits at least every six months.

The regulations went into ­effect immediately, but Romm said there will be a 90-day comment period, including a public hearing, and the pharmacy board will then consider changes before taking a final vote.

Todd Brown, executive ­director of the Massachusetts Independent Pharmacists Association, a group that represents most compounders, said he hopes the new rules will help regulators weed out companies that aren’t following the law.

“The pharmacy board’s philosophy was to count on pharmacists and pharmacies to do the right thing, and unfortunately, New England Compounding was a wake-up call that said not everyone is going to do the right thing,” Brown said.

Sophia Pasedis, a board member who is the lead pharmacist for Ameridose LLC, a Westborough compounder that has the same owners as New England Compounding, did not attend Thursday’s meeting. Ameridose agreed to recall all of its drugs Wednesday after federal regulators raised questions about its safety tests.

The company agreed to temporarily close Oct. 10, to give state and federal investigators time to look into its business and operations, and state officials have not decided whether it will be allowed to reopen Monday when the agreement expires. State health secretary Dr. JudyAnn Bigby said the recall will be taken into account “as we look at what the next step should be there.”

Bigby’s agency also announced Thursday that Christian A. Hartman, a specialist in pharmacy practice and patient safety, would chair a special commission that will study potential changes to state laws and regulations to fill the regulatory gaps between state and federal oversight.

Hartman is founder and president of the American ­Society of Medication Safety ­Officers, and director of clinical quality and patient safety at Wolters Kluwer Health. The new 10-member state commission is slated to make recommendations to the Patrick ­administration by Dec. 31.

Before then, state lawmakers have scheduled a series of three public hearings this month to scrutinize the Department of Public Health and its oversight of pharmacies, as well as the scandal at the drug testing lab the department formerly ran.

Kay Lazar can be reached at klazar@globe.com; Carolyn Y. Johnson at cjohnson@globe.com; and Liz Kowalczyk at kowalczyk@globe.com
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