December 6, 2012 — Cease and desist orders have been sent to three more compounding pharmacies in Massachusetts after the state Department of Health found safety violations.
Following a deadly outbreak of fungal meningitis, the state has been conducting “surprise” inspections of compounding pharmacies. The outbreak has been linked to contaminated injections of methylprednisolone acetate, a steroid shot used to treat back pain, which was produced by New England Compounding Center (NECC) in Framingham, Massachusetts.
The orders were sent to the following three compounding pharmacies:
- Oncomed Pharmaceutical Services of Massachusetts: Inspectors found problems with storage practices for chemotherapy drugs. The company has been ordered to cease all operations.
- Pallimed Solutions Pharmacy: The inspectors found improper components were used to make generic Viagra (sildenafil citrate). The company received a partial cease and desist order.
- Whittier Pharmacist, Inc.: The inspectors found problems with sterility procedures and sent the company a partial cease and desist order.
State regulators are working with officials from all three pharmacies. The companies are expected to re-open once they address the issues.
The Pharmacy Board of Massachusetts also announced the appointment of three new board members, who will fill three recent vacancies. In November, the director of the board, James Coffey, and his legal counsel, Susan Manning, were fired. State officials learned that the two had ignored a complaint from the Colorado Pharmacy Board that NECC was shipping drugs in bulk, in violation of their license.
Colorado sent the complaint in June — just three months before the outbreak was linked to more than 20,000 units of contaminated methylprednisolone acetate that NECC had shipped in bulk to 23 states.
Another vacancy on the board occurred when Sofia Pasedis, an executive from Ameridose, saw her term expire. Ameridose is owned by the same people as NECC. Both companies were shut down after the FDA found safety violations during recent inspections.
The three new board members were selected from a diverse background — executives from a rehabilitation center, major hospital system, and an insurance company.
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