2/12/2013 Entry Description
INDIANAPOLIS – The Indiana Board of Pharmacy agreed to revoke the New England Compounding Center’s license for its connection to the meningitis outbreak.
The Massachusetts-based pharmacy reached a voluntary revocation agreement on Friday with Indiana Attorney General Greg Zoeller’s office. The board approved the agreement Monday during its meeting in Indianapolis.
“Public health and safety is a top priority and today’s action was a necessary step to ensure this company, which put patients unnecessarily at risk, does not operate within our state’s borders going forward,” Zoeller said.
Zoeller said a license revocation means the company cannot operate in Indiana for at least seven years. The company could apply for a new license after that time, but the board would have to approve the license application.
In November, the Indiana Board of Pharmacy voted to indefinitely suspend NECC’s non-resident pharmacy license and the Attorney General’s office recently filed a licensing complaint against the company. Zoeller said the pharmacy failed to ensure its epidural steroid injections were safe for patients which led to devastating harm.
As of Feb. 4, the U.S. Centers for Disease Control (CDC) identified 10 deaths and 79 total cases of fungal meningitis in Indiana stemming from epidural steroid injections produced by NECC. Nationwide there were a total of 696 cases and 45 deaths across 20 states.
In September, the CDC in coordination with the Food and Drug Administration identified the NECC as the compounding pharmacy that produced the epidural steroid injections that caused the onset of meningitis in certain patients. Shortly after, NECC ceased production and initiated a recall of the drugs.
As a licensed non-resident pharmacy whose products were distributed and sold in Indiana, NECC is legally responsible for the “proper and safe storage and distribution of drugs and devices.”
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Contact Information: Name: Erin Reece Phone: 317.232.0168 Email: Erin.Reece@atg.in.gov Source found here |
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