Indiana Attorney General Greg Zoeller's office today filed an emergency petition asking the Indiana Board of Pharmacy to suspend the license of the Massachusetts compounding pharmacy linked to the meningitis outbreak. On Thursday, the Indiana State Department of Health said there were now 43 cases of fungal meningitis and three deaths in Indiana stemming from a tainted steroid injection produced by the New England Compounding Center.
Here's the news release from the Indiana Attorney General's office:
INDIANAPOLIS – Attorney General Greg Zoeller’s office today filed an emergency petition asking the Indiana Board of Pharmacy to suspend the license of the Massachusetts pharmacy linked to the meningitis outbreak.
On Thursday, the Indiana State Department of Health (ISDH) confirmed 43 cases of fungal meningitis and three deaths stemming from a tainted steroid injection produced by the New England Compounding Center (NECC) based in Framingham, Mass. As a licensed non-resident pharmacy whose products are distributed and sold in Indiana, NECC is legally responsible for the “proper and safe storage and distribution of drugs and devices.”
“It is tragically clear that this out-of-state pharmacy presents an immediate danger to public health and safety,” Zoeller said. “Our office will use all available resources to ensure Indiana patients are protected from any more harm and to pursue a formal administrative action against the company’s ability to operate in our state.”
The Indiana Board of Pharmacy will consider the petition for summary suspension at its next meeting which begins at 8:30 a.m. on Nov. 5. The meeting will be held in Room W064 of the Indiana Professional Licensing Agency, Indiana Government Center South, 402 W. Washington St., in Indianapolis.
If the suspension is granted, the NECC could not operate in Indiana for 90 days which would give the Attorney General’s Office time to file a formal licensing complaint before the pharmacy board. Once an administrative complaint is filed, the board could then determine the appropriate disciplinary action.
According to ISDH, there are now 1,502 people in Indiana who have been exposed to the contaminated medication through an epidural or joint injection. Patients exposed in Indiana have been contacted by their healthcare provider.
“These are uncharted waters, but we are learning more about these infections every day,” said Joan Duwve, M.D., Chief Medical Officer at ISDH. “The State Health Department has been working diligently with the Centers for Disease Control and Prevention to assist Indiana medical providers with the screening, diagnosis, and treatment of infections related to use of these contaminated products. We will continue to do so until this outbreak is resolved.”
In September, the U.S. Centers for Disease Control and Prevention (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 of Oct. 25, the CDC had indentified 328 cases of fungal meningitis across 18 states stemming from NECC’s tainted steroid injections. The cause of contamination of the steroid injections is still under investigation.
In-state pharmacies, including those engaging in sterile compounding, are subject to inspection by the Board of Pharmacy’s Compliance Officers. The board’s administrative rules and inspections of sterile compounding facilities address, among other things: policies and procedures; engineering controls/physical requirements; personnel training; labeling and documentation/records and reports; and quality assurance measures.
Non-resident pharmacies registered in Indiana are required by Indiana Code to comply with the laws and rules of the state in which they are domiciled. In order to be registered as an Indiana non-resident pharmacy, an applicant must submit numerous documents and fulfill various duties, including verification of the pharmacy’s licensure in its home state. The Indiana Board of Pharmacy relies on other state boards of pharmacy to regulate licensees in their jurisdiction.