Problems Found at More Compounding Pharmacies

December 6, 2012 — The Massachusetts Department of Health has issued warnings to three compounding pharmacies after finding problems with how they prepared or stored drugs. The department has begun “surprise” inspections after an outbreak of fungal meningitis was traced to New England Compounding Center (NECC), a compounding pharmacy located in Framingham, Massachusetts. Contaminated steroid injections, commonly used to treat back pain, have sickened more than 541 people and caused 36 deaths.

The following pharmacies have received cease and desist orders:

• Oncomed Pharmaceutical Services of Massachusetts: The company was ordered to cease operations because of problems with storage of chemotherapy medications.
• Pallimed Solutions Pharmacy: The company has been ordered to stop making sildenafil citrate (Viagra) because it was being made with improper components.
• Whittier Pharmacist Inc.: The pharmacy received a partial cease and desist order due to problems with procedures related to sterility of drugs.

All three pharmacies are working with state regulators and are expected to reopen once the concerns are addressed.

The Pharmacy Board of Massachusetts has also announced the appointment of three new board members, including executives from an insurance company, a rehabilitation center, and a major hospital system.

The new board members are replacing three board members who were fired or had their term expire. The most recent vacancy was left by Sophia Pasedis, an executive at Ameridose, the sister company of NECC. The FDA has shut down both NECC and Ameridose after finding safety violations.

The former president of the Massachusetts Pharmacy Board, James D. Coffey, and his legal counsel, Susan Manning, were fired in November for ignoring a complaint from the Colorado Pharmacy Board that NECC was shipping drugs in bulk. Had they addressed the complaint, it is likely that NECC would have been prevented from shipping more than 20,000 units of contaminated injections to 23 states. Neither Manning nor Coffey forwarded the complaint to the Massachusetts Department of Public Health.