In the nearly three years since the Drug Quality and Security Act of 2013 (DQSA) created a new level of fees, inspections and exemptions for registered outsourcing facilities, compounding pharmacy owners have been faced with the question of whether they should embrace the Food and Drug Administration’s registration and inspection procedures.
Their answer has been a resounding “no,” choosing instead to face the legal uncertainties and increased scrutiny under existing rules. Nationwide, only 63 outsourcing facilities have registered, and none of those are located in Georgia. (more…)
A change in the methods Food and Drug Administration (FDA) inspectors follow when inspecting compounding pharmacies could result in drastic regulatory outcomes. Since August 1, 2016, FDA investigators have been making preliminary assessments during inspections of non-outsourcing facilities on whether the facility is compounding human drugs in accordance with certain provision of Section 503A of the federal Food, Drug & Cosmetic Act (FD&C), as amended by the Drug Quality and Security Act of 2013.
Section 503A creates a safe harbor to allow human drug compounders who are not registered with the FDA as outsourcing facilities to compound drugs without having to comply with certain sections of the FD&C Act, including compliance with its Current Good Manufacturing Practices (CGMP). To make use of the safe harbor, the compounding pharmacy must meet certain conditions: (more…)