Massachusetts cracks down on compounding pharmacies

Bottles containing injectable steroids distributed by the New England Compounding Center, suspected in a meningitis outbreak.

Story highlights

  • The pharmacies must partially or totally stop operations
  • The state conducted surprise inspections after a meningitis outbreak
  • Nearly 700 cases and 45 deaths are blamed on the outbreak, the CDC says

Massachusetts health officials on Tuesday ordered 11 compounding pharmacies to completely or partially shut down, after unannounced inspections were conducted in the wake of a fungal meningitis outbreak.

The state's Department of Public Health began inspecting 40 sterile compounding pharmacies after the multistate outbreak last fall was linked to steroid injections distributed by the Massachusetts-based New England Compounding Center (NECC).

"Over the course of the unannounced inspections, partial or complete cease and desist orders were issued to 11 pharmacies for a range of violations," the health department said Tuesday.

Eight of the 11 have submitted corrective plans, officials said. They must implement the corrective measures, including renovations if necessary, and pass re-inspection.

Twenty-one other pharmacies were cited for minor deficiencies that have since been corrected or were "being addressed through corrective measures," the department said in a statement.

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Some 696 illnesses and 45 deaths in 20 states were blamed on the injections as of Monday, the Centers for Disease Control and Prevention said, noting the deaths are from "all causes among persons who meet the case definition and may not be directly attributed to a fungal infection."

FDA warns patients to be vigilant about drugs from compounding center

The public health department in October permanently revoked NECC's license to operate as well as the licenses of its three principal pharmacists. According to its report, state and federal investigators "identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public's health at risk."

Federal authorities also launched a criminal investigation into practices at the company.

A second compounding pharmacy surrendered its license after inspectors reported "significant" issues that could affect sterility, state health officials said.

Following the outbreak, Massachusetts Gov. Deval Patrick's administration launched "a series of aggressive initiatives" aimed at preventing a recurrence.

Those include new regulations requiring sterile compounding pharmacies to report volume and distribution to the state for the first time; the hiring of additional inspectors; and legislation filed earlier this month creating additional regulations and requirements.