A guide to how compounding activities need to change in the wake of the meningitis outbreak associated with the New England Compounding Center.
As all pharmacists should be aware, our profession was shattered by the tragic meningitis outbreak that began in late 2012 and was caused by the New England Compounding Center’s national distribution of sterile products tainted by a fungus. Not only did this exact a significant toll on individuals who received these products, including patient deaths, it also led to questions about lapses in state regulations for compounding pharmacies and the role of health-system pharmacists who purchased outsourced products such as those produced by the NECC.
In the aftermath of this tragedy, new legislation has been passed that aims to balance the rights of pharmacists to compound medications for patients' legitimate medical needs with controls at the state and national level designed to provide oversight of compounding facilities. The new federal legislation, signed into law in November 2013, is called the Drug Quality and Security Act. It refers to 2 types of compounding pharmacies. Section 503A allows for traditional local compounding, such as we have always had. Section 503B, which is new, codifies a licensure process for “outsourcing facilities,” or sterile compounders. This section applies to national companies that prepare compounded medications in advance of a patient prescription. While licensure is completely voluntary, those facilities that apply for it must fulfill a number of requirements, including paying a fee, complying with Good Manufacturing Practices, and being open for FDA inspections.
The legislation will help improve pharmacy practice. However, it requires each practice site to conduct a full inspection of its current operations. This is one of the most important steps to ensure continued optimal patient care. While performing this process, there are a few requirements that should be taken into account.
While none of this will be easy, it is essential for pharmacists to retain ownership over compounding and to provide our patients with confidence that we are exercising appropriate oversight of the drug supply chain.
How has your department responded to the new compounding regulations? I would enjoy hearing what you have done.