is currently being given a careful look by regulatory officials. Legally, pharmaceutical compounding performed by prescribers falls under the purview of state medical boards. Much like performing arthroscopic surgery, there are no black and white regulations that apply to these services. Pharmacy boards across the country have held cross-practice forums on the matter, but remain on the outer boundaries of formal decision making.
These circumstances create a unique regulatory environment where enforcement is typically based on reporting of negative outcomes or complaints. When enforcement occurs, regulatory agencies are often unaware of the scope of standards that apply to the practice. Federal requirements established by the Drug Quality and Security Act (DQSA) also apply to physician-based compounding, but communication between state and federal agencies is still contingent upon reporting.
ITL Consulting provides a spectrum of services to physician-based compounding businesses from 'hands-on' to regulatory counsel. Since 2013 when the DQSA was signed into law by the Obama administration, we have kept a keen eye on this unique environment and have observed specific regulatory and enforcement trends. As we continue to monitor and engage in the DQSA implementation process, we continue to provide our professional association affiliates guidance in their advocacy efforts and help our physician-based compounding clients successfully navigate their evolving landscape.