Compounding Law Five Years Later

摘要

It has been five years since the passage of the Drug Quality and Security Act (DQSA) meant to address safety concerns about compounded drugs. The Food and Drug Administration (FDA) is still laboring to fulfill the law's provisions, which were intended to allow the agency to walk the fine line between assuring public safety while ensuring access to legitimately and safely compounded drugs. It is a tough balancing act, especially given the FDA's chronic funding shortage, which impedes regulation development, inspections, and enforcement. At hearings in front of the House Energy and Commerce Committee on January 30, FDA Commissioner Scott Gottlieb, MD, admitted that the FDA's compounding regulatory program "is a program where we do operate by, in some cases, begging, borrowing, and stealing from other aspects of the agency".