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[ATG] Massachusetts pharmacy agrees to stop operating in Indiana, board to vote Monday
Start Date: 11/1/2012Start Time: 12:00 AM
End Date: 11/1/2012End Time: 11:59 PM
Entry Description

INDIANAPOLIS The Massachusetts pharmacy linked to the meningitis outbreak agreed on Wednesday to an indefinite summary suspension of its license to do business in Indiana, according to Attorney General Greg Zoeller.

Last week, Zoeller’s office filed an emergency petition asking the Indiana Board of Pharmacy to suspend the license of the New England Compounding Center (NECC) which is based in Framingham, Mass. The Indiana Board of Pharmacy will consider and vote on the new agreement for indefinite summary suspension at its meeting Monday beginning at 8:30 a.m. The meeting will be held in Room W064 of the Indiana Professional Licensing Agency, Indiana Government Center South, 402 W. Washington St., in Indianapolis.

“The agreement by the New England Compounding Center to have their pharmacy license suspended is encouraging,” Zoeller said. “The tragic and fatal consequences of the company’s actions regarding the sterility of their drugs cannot be overlooked and our office will use all resources available to make sure they are held accountable.” 

On Thursday, the Indiana State Department of Health (ISDH) confirmed 48 cases of fungal meningitis and three deaths in the state stemming from a tainted steroid injection produced by NECC. 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.”

If the board votes to accept the agreement, the company could not operate in Indiana and the Attorney General’s Office will move forward with filing 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.

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. 31, the CDC had indentified 377 cases of fungal meningitis and 28 deaths across 19 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.



Contact Information:
Name: Erin Reece
Phone: 317.232.0168
Entry Type:
Press Release
Entry Category:
  • Announcements
  • Category:
  • Family & Health
  • Government
  • Residents
  • Agency Name
    Attorney General

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