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October 28, 2012

Massachusetts shuts down second compounding pharmacy

The state of Massachusetts has shut down another compounding pharmacy over sterility concerns after a surprise inspection was carried out last week.

By Nikitha Ladda

The state of Massachusetts has shut down another compounding pharmacy over sterility concerns after a surprise inspection was carried out last week.

The inspection was prompted by the nationwide meningitis outbreak linked to the New England Compounding Center (NECC).

Department of Public Health Healthcare Safety and Quality director Dr Madeleine Biondolillo said inspectors visited Infusion Resources, a compounding pharmacy in Waltham that prepares sterile, injectable medications.

Biondolillo said in a statement on Sunday; "Inspectors noted significant issues with the environment in which medications were being compounded, which has called into question the company’s compliance with nationally-accepted pharmacy standards and Massachusetts regulations."

The pharmacy was last inspected when it opened in December 2009 and, at the time, it was found to be in compliance with all requirements for sterile compounding and since then, no complaints have been received.

"Inspectors noted significant issues with the environment in which medications were being compounded, which has called into question the company’s compliance with nationally-accepted pharmacy standards and Massachusetts regulations."

But, due to "a variety of notable findings" regarding the conditions of the medication production areas on Tuesday, inspectors have expressed concern for the sterility of products.

"On October 23rd, the Board of Pharmacy issued an immediate cease and desist and quarantine notice, preventing Infusion from dispensing any drugs or medications. And this weekend, DPH secured the voluntary surrender of Infusion’s Pharmacy License," added Biondolillo.

The news follows an announcement by state officials last week that the NECC, which is believed to be responsible for 23 deaths and 304 diagnoses of meningitis, sacrificed sterility procedures in order to ship drugs around the country more quickly.

The company even failed to wait for drug sterilisation results to come back for a batch of steroids implicated in the meningitis outbreak before shipping them.

The Department of Public Health said it is executing a series of aggressive actions to protect public safety and enhance oversight of this industry following the national meningitis outbreak.

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