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December 5, 2012

Official: Meningitis outbreak could have been prevented

(Continued)

“It is a concern to us whenever we see a board that doesn’t have the same type of protections for citizens of pharmacies and compounding pharmacies outside its borders,” Miller said.

Brown said he has been in contact with legislators who have agreed to file legislation regarding the registration of out-of-state pharmacies in Massachusetts, though he declined to name lawmakers with whom he has been working.

Miller also raised concerns about the amount of time allowed before a pharmacy shut down by the board can have a hearing. The emergency regulations specify that a pharmacy is entitled to a hearing within 21 days of receiving a cease-and-desist order, but Miller said that could be very detrimental to both the business and patients looking to get their prescriptions filled. He recommended holding a hearing within five days.

“We’re placing our patients at risk with not being able to obtain their medications,” Miller said.

The emergency regulations adopted by the board require compounding pharmacies to report to the state the volume and distribution of drugs to determine whether they are acting more like a manufacturing facility that would be subject to Food and Drug Administration oversight.

The regulations also require pharmacies to report to the state when they are the subject of an investigation by another state or federal authority, and create stiffer penalties if pharmacies fail to comply with rules and regulations.

Brown suggested clarifying the definition of compounding, and limiting the requirement that pharmacies report “adverse events” to the state to those associated with compounding or when compounding products cause serious harm attributed to the accuracy, potency or sterility of the product.

Paul Garbarini, a pharmacist and attorney who represents pharmacies sanctioned by the board, also took issue with the requirement that pharmacists report pending criminal charges to the board.

“I think it flies in the face of common sense and fair play,” he said, suggesting convictions would be more relevant.

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