Monday, April 1, 2013

MASS. Legislature to hold hearing on new regulations for compounding pharmacies | VOX6 BREAKING NEWS

Legislature to hold hearing on new regulations for compounding pharmacies | VOX6 BREAKING NEWS

Pols may doctor Gov. Deval Patrick’s pharmacy bill

 

Lawmakers will examine Gov. Deval Patrick’s compounding pharmacy bill and may add their own measures as they try to plug regulatory loopholes revealed by the deadly nationwide fungal meningitis outbreak tied to Framingham-based New England Compounding Center.
“There are a number of sections that absolutely make a lot of sense, but we’re going to come up with some ideas as well,” said state Rep. Jeffrey Sanchez (D-Jamaica Plain), the chairman of the Joint Committee on Public Health. “We’re doing this in as thoughtful a manner ... so that this never happens again.”
The meningitis outbreak has led to at least 730 
cases and killed 51 patients in 20 states, according to the Centers for Disease Control and Prevention.
Patrick’s bill, which one former federal official labeled “a great first step,” would tighten restrictions on Bay State compounding pharmacies by requiring that they obtain special licenses and by reducing the mandated number of pharmacists that sit on the 11-member Board of Pharmacy. The state also would hire more inspectors and install whistle-blower protections for employees.
“The Department of Public Health has made great strides to increase regulation of pharmacies over the past six months, and the governor’s legislation would further enhance our oversight of this industry,” said Department of Public Health spokesman Dave Kibbe in a statement.
Interim Department of Public Health Commissioner Lauren Smith, compounding pharmacists and a representative from the Massachusetts Hospital 
Association are all expected to testify as the committee looks at a dozen pharmacy-related bills in tomorrow’s hearing.
Last week, Woburn-based Pallimed Pharmacy recalled its sterile compounding products after a joint inspection by the state pharmacy board and the FDA revealed vials contaminated with unidentified “visible particulates.”
That news surprised Sanchez, who told the Herald a trade group had showed him around Pallimed in November, citing it as a standard-bearer for the industry.
“I’m blown away. Flabbergasted,” Sanchez said. “I’m speechless at this point.”
Pallimed spokesman Scott Farmelant said, “Pallimed has always embraced the best practices in its procedures in terms of providing the highest possible level of patient safety.”
 
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