FDA & Medical Counsel explains, interprets, and advises clients on FDA compliance with the contours of the 2013 Compounding Quality Act, or DQSA, which sets out conditions for qualifying as a 503A, such as no office use and nominal out-of-state sales, but exempts traditional pharmacies from GMP, labeling, and NDA requirements. If a facility cannot meet those conditions, or otherwise violates the Food, Drug & Cosmetic Act, it must register as a 503B outsourcing facility and meet higher GMP, labeling, recordkeeping, and reporting standards; in exchange, however, a 503B may dispense for office use and with no limit on out-of-state sales. requirements for both 503A traditional pharmacies and 503B outsourcing facilities.
Since the enactment of DQSA, FDA has issued numerous Guidances For Industry setting out its positions on specific points of law, its expectations, and its enforcement priorities. There remain gray areas and significant pushback from industry. FDAmc can guide your facility through this ever-changing obstacle course.
Our practical, actionable advice is also based on FDA’s own enforcement history – a guidepost to achieving real world compliance. As the practices, precedent, and guidance surrounding the new law continue to evolve, so do our services.