Regulations eyed in meningitis outbreak
(CBS News) The Centers for Disease Control said Thursday that 14,000 people may have received the tainted steroid shots that sometimes led to meningitis. Idaho has become the 11th state to report an infection.
There are now 170 cases and 14 people have died.
The New England Compounding Center, NECC, shipped more those 17,000 vials of the drug blamed for the outbreak to 23 states.
On Thursday, Dr. Madeleine Biondolillo, the safety director of the Massachusetts Department of Health said: "Certainly NECC was not operating as far as the investigation has seen so far, in accordance with the Massachusetts licensing regulation."
That's because Massachusetts law says compounding pharmacies, which mix custom made medicines, must have a prescription for every patient for each dose they send out. It appears NECC shipped the tainted vials of steroid to medical facilities in bulk without these prescriptions.
The NECC released a statement to CBS News, saying: "Our intent has always been to comply with all regulations, and cooperate with all regulatory agencies."Fungal meningitis toll rises to 170 infected, 14 dead
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Also on Thursday, government health officials acknowledged there is a regulatory gap when it comes to compounding pharmacies.
For instance, Massachusetts does not have the authority to track how many vials of a drug are produced.
At the federal level, the Food and Drug Administration does not have clear authority to examine records in a compounding pharmacy. The FDA is seeking more authority.
Pharmacist Eric Kastango served on a panel creating federal safety standards for the compounding pharmacy industry, and defended the FDA's efforts.
"The FDA has worked very hard over the last several years to try to promulgate regulations to clearly define when does a compounding pharmacy exceed its authority and become a manufacturer under the purview of the FDA," Kastango said.
The CDC has found that so far the main fungus responsible for the meningitis is called exserohilum. This organism has never been found to cause meningitis before and a panel of infectious disease experts has been called in to figure out how to diagnose and treat it.
Editor's note: This story was updated to include a statement from the NECC which was received after Dr. LaPook's report aired on the CBS Evening News with Scott Pelley.
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