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Pharmacists request changes to emergency regulations

Pharmacy industry executives requested changes Tuesday to emergency state regulations adopted last month in the wake of the national fungal meningitis outbreak.

Under the new rules, specialty pharmacies similar to New England Compounding Center, the Framingham company whose contaminated drugs are blamed for the outbreak, are required to report to state regulators the volume of medications they are making and whether they have detected contamination in their laboratories.

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During a public hearing Tuesday, industry groups indicated they support these requirements but said other portions of the new regulations are unfair to pharmacists. The rules allow the state pharmacy board to shut down a pharmacy if it believes its products are a threat to public health and requires the board to hold a hearing within 21 days.

A hearing should be required in five business days, said David Miller, executive vice president of the International Academy of Compounding Pharmacists. Any longer could jeopardize the business and patients who need compounded medications, he said.

Miller and Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, also argued that regulators need to better define “adverse events” in the new rules. Pharmacies are required to report “all adverse events relating to preparation of medications in that pharmacy’’ within seven days.

Brown said this should include only serious adverse events that are caused by compounding -- the preparation of a drug -- not by other factors such as improper administration of a drug.

Miller and Brown said Massachusetts also should adopt regulations to oversee out-of-state pharmacies that sell drugs in Massachusetts, such as requiring them to register with the state. Only Massachusetts, Pennsylvania, and Georgia lack such oversight, Miller said.

Public health officials will review the comments and could revise the regulations.

Liz Kowalczyk can be reached at
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