Article from Boston Globe Notes That New England Compounding Center is under Investigation by State and Federal Authorities After Meningitis Outbreak

Compounding pharmacy oversight is questioned after meningitis outbreak

By Liz Kowalczyk and Kay Lazar

| Globe Staff October 06, 2012

Compounding pharmacies started as small mom-and-pop stores that mixed hard-to-find medications for local doctors and their patients who had allergies, difficulty swallowing, or otherwise could not take mass-produced drugs.
But amid growing drug shortages in the pharmaceutical industry, some large compounders such as the New England Compounding Center stepped in and ­expanded their business far beyond the industry’s homespun roots.
The Framingham company, whose products are implicated in a nationwide outbreak of fungal meningitis that sickened more people Friday, listed dozens of products online and apparently took thousands of orders from doctors, clinics, and hospitals in at least 23 states, a transformation that regulators have not kept pace with, critics and even some industry executives said.
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Hundreds at risk in meningitis outbreak Health officials are now trying to track down people in 23 states who got epidural steroid injections. NBC’s Robert Bazell reports.

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Meningitis Outbreak Is Growing As More Are Being Reported Sick

Rare US meningitis outbreak grows; 4 dead, 22 sick

MIKE STOBBE, Associated Press Copyright 2012 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

MIKE STOBBE, Associated Press, TRAVIS LOLLER, Associated Press

Updated 5:18 a.m., Thursday, October 4, 2012

Read more: http://www.sfgate.com/news/article/Rare-US-meningitis-outbreak-grows-4-dead-22-sick-3916606.php#ixzz28KotOAqR

Some say FDA oversight needed State boards lack staff to fully monitor

Duane Marsteller and Walter F. Roche Jr.

The Tennessean

The fungal meningitis outbreak centered on Nashville has renewed debate over who should regulate specialty pharmacies that compound medicines.

While they fall under the purview of state pharmacy boards, critics contend those state agencies are often too understaffed and underfunded to adequately monitor such facilities. They want the U.S. Food and Drug Administration to take a greater regulatory role.

But the FDA has said it will do that only on a case-by-case basis — such as the meningitis outbreak that surfaced in Nashville and has since spread to four other states.

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