Reports from the FDA and the Massachusetts Board of Registry in Pharmacy detail license violations by the New England Compounding Center and unsanitary conditions at its facility.
Initial reports from state pharmacy regulators and the FDA indicate that the New England Compounding Center (NECC) violated the terms of its license and maintained its facilities in a manner that left the medications it produced vulnerable to contamination. Three lots of methylprednisolone acetate, an injectable steroid used to treat back pain, produced at the NECC’s Framingham, Massachusetts, facility have been linked to 338 cases of fungal meningitis in 18 states and 25 deaths as of October 26, 2012.
In a report
released on October 23, 2012, the Massachusetts Board of Registry in Pharmacy note that the NECC had distributed large batches of medication rather than receiving a prescription for each individual patient before distribution, as required by its license. According to the report, NECC staff showed investigators lists of patients generated by a clinical facility and sent to NECC to obtain medication and suggested that these lists were considered be equivalent to authorized prescriptions from a physician. The report notes that this practice does not accord with Massachusetts regulations.
The pharmacy board report also enumerates “serious health and safety deficiencies related to the practice of pharmacy” discovered during inspections of the NECC facility. The report notes that NECC distributed 2 of the 3 recalled lots of methylprednisolone acetate before receiving sterility testing results. (According to NECC records, no contamination was discovered in sterility testing, but the adequacy of its testing methods is under investigation.) In addition, NECC failed to keep its medications in an autoclave for a minimum of 20 minutes during final sterilization, as mandated by proper standards, and failed to test its autoclaves to ensure that they were in proper working order.
The pharmacy board report as well as an FDA form
released on October 26, 2012, details a number of findings of contamination of NECC medications as well as conditions at the NECC facility that could lead to contamination. Out of a bin of 321 vials of recalled methylprednisolone acetate at the facility, inspectors noticed “greenish black foreign matter” in 83 vials and “white filamentous material” in 17 vials. Although the NECC’s sterility test of a single 5 ml vial of the steroid had returned a sterile result, FDA tests found microbial growth in 50 of 50 vials tested.
The FDA report lists the results of the NECC’s own monitoring of its facility for bacteria and mold in recent months, which in some instances identified levels that required action. “There was no investigation conducted by the firm when levels exceeded their action limits and there was no identification of the isolates,” the report reads. “No documented corrective actions were taken to remove the microbial contamination (bacteria and mold) from the facility.”
Possible sources of contamination observed at the NECC facility included:
Residual powder was observed on powder hoods, which could lead to contamination of compounded medications.
“Tacky” mats, which remove potential contaminants from shoes before one enters clean rooms, were soiled with debris.
A pool of water was observed around a boiler adjacent to clean room that could provide an environment for contaminant growth.
Condensation and discoloration was observed on parts of various autoclaves used to sterilize equipment used in formulating medications.
Dark particulate and white filamentous matter was observed covering the louvers of the HVAC return located near an autoclave used to sterilize formulated bulk drug suspensions.
Yellow and greenish residue was observed lining the return of a weigh station hood used to weigh active ingredients and other raw materials used in formulating sterile drug preparations.
A recycling center neighboring the NECC facility and sharing its owners produced a significant amount of dust, which could have entered the compounding facility’s HVAC system.