Massachusetts health inspectors have issued cease-and-desist orders on 11 compounding pharmacies and cited 21 others for minor deficiencies following a deadly outbreak of fungal meningitis linked to contaminated steroid shots made by New England Compounding Center (NECC), a Massachusetts specialty pharmacy. The shutdown orders and citations were issued after unannounced inspections of 40 pharmacies across the state.
Compounding pharmacies custom-mix FDA-approved drug ingredients based on doctors’ prescriptions for individual patients. However some specialty pharmacies, like NECC, mass produce custom drugs and distribute them across state lines. Drug companies are regulated by the FDA and must undergo routine inspections, but the oversight of pharmacies is left up to state pharmaceutical boards.
The fungal meningitis outbreak late last year raised serious concerns over how compounding pharmacies are regulated. A congressional investigation into the pharmacies is currently underway and legislation to increase federal oversight of the industry is expected soon.
Three lots – or about 18,000 – steroid shots manufactured by NECC were distributed to medical facilities in 23 states from late May through late September 2012. About 14,000 people received the shots, which were injected into the spine to treat back or neck pain, or into joints to treat joint pain. Nearly 700 people have become infected by the fungus and 45 have died after receiving the shots. Victims suffered from meningitis (a life-threatening inflammation in the membrane surrounding the brain and spinal cord), strokes, and peripheral joint infections.
Source: ABC News