Who is responsible for regulating compounding pharmacies?

The responsibility for regulating compounding pharmacies primarily falls to both state and federal agencies. The State Boards of Pharmacy oversee the activities of pharmacies within their jurisdictions, establishing rules and regulations for compounding practices to ensure patient safety and proper standards. The Federal Drug Administration (FDA) also plays a significant role, particularly for interstate commerce and ensuring that compounded drugs meet safety and efficacy standards.

While out-of-state inspections and regulations may occur, especially when pharmacies engage in interstate distribution or are subject to FDA oversight, they are not solely responsible for all regulatory aspects of compounding pharmacies. It is the collaborative efforts of both state and federal agencies that ensure comprehensive regulation of compounding practices, which includes adherence to USP standards and state laws.

Therefore, the correct answer highlights the dual oversight role of both state and federal agencies in regulating compounding pharmacies to ensure public safety and compliance with legal standards.