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Second Mass. compounding pharmacy surrenders license

By William Hudson, CNN
updated 8:00 AM EDT, Wed October 31, 2012
State officials have found a second Massachusetts pharmacy in violation of state regulations.
State officials have found a second Massachusetts pharmacy in violation of state regulations.
STORY HIGHLIGHTS
  • Investigators found "significant" issues in an inspection of Infusion Resource
  • The company surrendered its pharmacy license over the weekend
  • It has recalled all compounded products dispensed in the past month
  • The inspections are conducted in the wake of a multistate meningitis outbreak

(CNN) -- A second Massachusetts compounding pharmacy surrendered its license after state inspectors found "significant" issues that could affect sterility, state health officials said.

The pharmacy, Infusion Resource, was also found to have a center for giving intravenous medications to patients in violation of state regulations, which require a clinic license, Dr. Madeleine Biondolillo, director of the Massachusetts Department of Public Health Bureau of Healthcare Safety and Quality, said Sunday.

The state Board of Pharmacy immediately issued a cease and desist notice to Infusion Resource after the October 23 inspection revealed the violations, she said. Over the weekend, the Department of Public Health "secured the voluntary surrender of Infusion's pharmacy license."

The company, which compounds antibiotic and nutritional IV medications for home use, said in a statement it has since recalled all compounded products dispensed in the past month, effecting 38 patients.

"No issues were cited related to the integrity of our products nor to the quality of our compounding practices," said Bernard Lambrese, Infusion Resource CEO, in a statement.

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"It is correct that Infusion Resource does not have a clinic license from the Commonwealth of Massachusetts. The space in our facility is intended for patient education, validation of patient and caregiver skills, medication counseling, medication education, teaching and training."

What is a compounding pharmacy?

Massachusetts Gov. Deval Patrick said last week the state would immediately begin unannounced inspections of all Massachusetts pharmacies and require that they submit annual reports detailing what they produce and distribute.

That announcement came in the wake of the fungal meningitis outbreak that has caused 25 deaths and 354 illnesses, linked to the Massachusetts-based New England Compounding Center. Seven of those illnesses are peripheral joint infections that specifically affect a joint such as a knee, hip, shoulder or elbow.

Infusion Resource is not linked to the outbreak.

The incident began unfolding September 24, when the department was notified about a cluster of six rare fungal meningitis cases in Tennessee. The patients shared several risk factors, including having received an epidural injection of a steroid -- methylprednisolone acetate -- that had been compounded at the NECC in Framingham.

The department soon learned that the suspect product had been distributed to more than 14,000 patients in 23 states.

FDA: Drug maker had internal warnings months before meningitis outbreak

The Department of Public Health has asked two other companies -- Ameridose and Alaunus Pharmaceutical -- to cease all pharmacy operations based on their shared ownership and leadership with NECC.

"NECC's transparency in dealing with the board since inception in 1998 demonstrates its good faith intention to operate in compliance with the requirements of its license," said Paul Cirel, a Boston-based lawyer representing the compounder, in a statement last week.

"Furthermore, the company's intention and best efforts at compliance are equally applicable in every other state in which it has been licensed."

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