An Indianapolis compounding pharmacy has been cited for inappropriate procedures in a Food and Drug Administration report. The FDA conducted 31 inspections nationwide after a Massachusetts-based pharmacy distributing steroid shots contaminated with meningitis last year.
The FDA used a risk-based model to identify the pharmacies that needed inspection and investigated whether their practices may have posed a risk of producing “unsafe or poor quality sterile drugs.”
An inspection of Nora Apothecary and Alternative Therapies in Indianapolis says the pharmacy did not appropriately test its products or maintain a sterile environment.
Nora Apothecary and Alternative Therapies Owner and pharmacist Charles Lindstrom says he understands the FDA does not want another outbreak, but maintains his business has been upstanding since it opened in 1962.
“We recently passed the state board inspection after the FDA were here,” he says. “We are and have always been compounding prescription using the highest quality ingredients with the utmost care to ensure the health and safety of our patients.”
Lindstrom says the FDA inspection also held his facility to higher standards than those it is legally required to abide by. However, according to records from the Indiana Attorney General’s office, Nora Apothecary’s license was put on probation in 2007 because of discrepancies in how prescriptions were being distributed.
Because of last year’s outbreak and the most recent inspections, FDA Commissioner Margaret Hamburg is calling on Congress and states to pass new legislation to better oversee compounding pharmacies.
Officials with the State Board of Pharmacy, which oversees the facilities in Indiana, were not available for comment, but a statement released shortly after the meningitis outbreak says “The Board of Pharmacy works hard to ensure that our licensed facilities are thoroughly inspected.”