As previously noted here, we expected FDA’s enforcement activities and scrutiny of compounding pharmacies to increase after last year’s deadly outbreak of fungal meningitis tied to steroid injections compounded by the New England Compounding Center (“NECC”).
Recently, FDA took steps to determine whether certain compounding pharmacies known to have produced high-risk sterile drug products in the past continue to have poor sterile drug production practices that pose a significant threat to public health. In a summary called, “2013 FDA Pharmacy Inspection Assignment,” FDA explained that it used a risk-based model to identify 29 pharmacies for priority inspections of their sterile drug production practices. FDA’s risk-based model identified a pharmacy for a priority inspection if there was a reported death or the pharmacy met at least two of the criteria for serious adverse event reports, historical inspection data, and product quality reports. During the 29 inspections, FDA identified two secondary pharmacies to inspect based upon their associations with initial priority inspections, for a total of 31 inspections.
The inspections were performed in 18 states from February to April. Ninety percent of the inspections were done in conjunction with state boards of pharmacy or other state officials. During each inspection of a pharmacy’s compliance with sterile production standards, what FDA refers to as “highly-skilled certified drug investigators” visually examined pharmacy’s practices and procedures by watching the production environment, production equipment, facility design, and personnel practices and behavior. FDA also questioned pharmacy technicians and gathered information on the pharmacy’s operations, standard operating procedures, and products. The agency took samples when an abnormality was noticed. Additionally, FDA investigated the pharmacy’s sterility and endotoxin failures and air flow studies.
All of the firms, except one that did not produce sterile drugs, received a FDA Form 483 containing FDA’s inspectional observations. Examples of FDA’s inspectional observations include, but are not limited to, lack of adequate air filtration systems and insufficient microbiological testing. According to FDA, it will take aggressive action, including enforcement action, under its existing legal authority to protect the public health. It noted, however, that if a compounding pharmacy is operating within the bounds of traditional pharmacy compounding, FDA may not be able to take enforcement action against them depending upon whether other provisions of the law are violated. In cases where FDA cannot take enforcement action, it will refer cases to state boards of pharmacy.
One pharmacy that was inspected, Nora Apothecary & Alternative Therapies, has announced a voluntary multi-state recall of all sterile drug products it compounded that have not reached the expiration date because of concerns FDA raised about its quality control processes that present a lack of sterility assurance.