Over the past several weeks we have witnessed the unfortunate harm as a result of the contaminated products prepared at the New England Compounding Center (NECC). Given the broad nature of the meningitis outbreak, we can all expect changes within our own practices and regulatory oversight. I am confident that highly skilled medication safety experts such as ASMSO members will lead the changes needed to provide safe and effective medications for the patients we serve. I encourage all ASMSO members to become involved at a local, state, or national level to better define sterile compounding practices and provide guidance during these difficult times.
Enclosed are some useful resources to assist you with the management of this event and USP 797.
CDC Multistate Outbreak Investigation: http://www.cdc.gov/HAI/outbreaks/meningitis.html
NECC Customer List: http://www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325467...
USP 797 QA Management System: http://www.pharmacyonesource.com/applications/simplifi797/
USP 797 State Requirements: http://www.clinicaliq.com/797-state-survey
IJPC Gap Analysis http://www.ijpc.com/USP/IJPC%20USP%20797%20GAP%20Analysis.pdf
Christian Hartman, PharmD, MBA, FSMSO