Compounding Pharmacies Cited
Written by Faith Anderson on February 6, 2013
Compounding Pharmacies Required to Make Changes
The Massachusetts Department of Public Health (DPH) reports that pharmacies that have been ordered to cease operations will be required to submit a written plan of corrective action to the state’s Board of Pharmacy. They must then implement the corrective measures and pass re-inspection before being allowed to continue operations. According to DPH, eight of the 11 pharmacies have submitted corrective plans at this point. “While these results are troubling, this process has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts,” said DPH interim Commissioner Dr. Lauren Smith. On February 1, Republicans in the House of Representatives established a deadline for the U.S. Food and Drug Administration to produce documents associated with the fungal meningitis crisis, saying the agency has produced few documents and that those it has provided “raise new and troubling questions” about the FDA’s oversight of NECC.
Contact a Skilled Attorney for Legal Help
The deadly meningitis outbreak was caused by tainted steroid injections mixed by the New England Compounding Center and distributed to approximately 14,000 patients throughout the United States. The fungal meningitis crisis, which the U.S. Centers for Disease Control and Prevention (CDC) reports resulted in 45 deaths nationwide, led NECC to recall more than 17,000 vials of methylprednisolone acetate injections believed to be contaminated by a fungus. FDA officials who investigated the compounding pharmacy following the deadly outbreak reported unsterile conditions and found fungus in a number of sealed, supposedly sterile, vials of medications set to be distributed to healthcare centers throughout the country. The latest wave of compounding pharmacy inspections indicates that the issue of potentially contaminated drugs being mixed at unsterile compounding pharmacies remains a serious problem. If you believe you have been adversely affected by a tainted pharmaceutical drug, contact an experienced attorney in your area for legal help.