Infusion Resource, a Massachusetts compounding pharmacy that produces sterile injectable medications for patients recently discharged from the hospital, has voluntarily surrendered its pharmacy license following an unannounced inspection of its facilities by the Massachusetts Department of Public Health (“DPH”) on October 23, 2012. This was the first inspection of Infusion Resource since it began operations in December 1999, at which time it was found to be in compliance with sterile compounding requirements. Since then, no complaints have been received against the compounding pharmacy.
The DPH inspection of Infusion Resource’s facilities conducted the prior week found “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. Due to a variety of notable findings regarding the conditions of the medication production areas, inspectors expressed concern for the sterility of products. Additionally, there was an adjacent space set up for giving patients intravenous medications onsite. Infusion Resource does not have an appropriate clinic license to conduct these activities, which is a violation of state regulations.”
As a result of its inspection, the DPH issued a cease and desist and quarantine order against Infusion Resource on October 23, 2012, preventing it from dispensing any medications. Infusion Resource subsequently voluntarily surrendered its pharmacy license to the DPH, which stated “there is no current evidence of contaminated products at Infusion Resource.”
In response to the recent revelations regarding some compounding pharmacies located in Massachusetts, the DPH stated, “At Governor Patrick’s direction we are filing regulations to require compounding pharmacies in Massachusetts to submit frequent reports of production, volume and distribution of sterile, injectable medications. This reporting will allow us to better identify large-scale operations acting more as a manufacturer, which requires federal licensure and additional scrutiny. We are also launching a special commission to examine best practices in other states and potential changes to state law or regulations to help us keep pace with an evolving industry and close the regulatory grey area that exists between state and federal oversight.”
Why were Infusion Resource’s facilities not inspected by the DPH from December, 1999 until October, 2012, a period of almost 13 years? If a yearly inspection of Infusion Resource would have been done, would the problems recently revealed have been found earlier and corrective actions taken sooner?
If the initial compounding pharmacy miscreant, the New England Compounding Center (“NECC”) that is at the center of the recent fungal meningitis outbreak in the United States that has killed 25 and infected 354 people in 19 states as of October 29, 2012, been inspected yearly by the Massachusetts DPH, could the fungal meningitis cases have been prevented and the pain and suffering of those affected by the deadly disease and their families been avoided? If the compounding pharmacies in Massachusetts knew that they were subject to unannounced inspections of their facilities at any time, would they have allowed non sterile and other improper conditions to exist in their facilities?
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