In the wake of the 2012 fungal meningitis outbreak caused by drugs manufactured by the New England Compounding Center (NECC) in Framingham, Massachusetts there has been a call for greater oversight of compounding pharmacies in the U.S. This led to the passage of the Drug Quality and Security Act in 2013. The safety of patients is the first priority for all home infusion providers. The National Home Infusion Association (NHIA) believes the industry should do everything possible to prevent a repeat of the failures of NECC. Awareness and understanding of the issues surrounding the compounding of drugs is vital.
Oversight of sterile compounding falls primarily to the states and is typically governed by the individual state's Board of Pharmacy, however the Food and Drug Administration (FDA) also maintains authority to inspect pharmacies for insanitary conditions. In some states, the Board of Medicine (or similar entity) regulates sterile compounding that occurs in physician offices. Additionally, most pharmacies maintain active accreditation from an agency that performs rigorous inspections for compliance with state laws and internal policies. The majority of state laws and accreditation standards are based on the principles outlined in the U.S. Pharmacopeial Chapter <797> Pharmaceutical Compounding – Sterile Preparations.
The NHIA Compounding Advocacy Center is a clearinghouse of information on compounding pharmacy legislation and regulation for home infusion providers. NHIA urges you to sign up for the NHIA ListServ to get regular updates from the association on the issue.