What are outsourcing facilities classified as under the FDA?

Outsourcing facilities are classified as 503B facilities under the FDA. This classification refers to facilities that compound sterile drugs and are subject to specific regulations outlined in the Drug Quality and Security Act (DQSA). These facilities are permitted to produce larger batches of compounded medications without a patient-specific prescription, which distinguishes them from compounding pharmacies that operate under section 503A.

503B facilities are required to comply with more stringent FDA regulations concerning good manufacturing practices, reporting adverse events, and adhering to inspection protocols. These regulations are designed to ensure the safety, quality, and efficacy of compounded drugs, especially as they are intended for a broader patient population rather than individualized care.

In contrast, 503A facilities are traditional compounding pharmacies that make medications for specific patients based on a prescription and are not subject to the same level of federal oversight. Understanding this distinction is crucial for recognizing the regulatory landscape surrounding compounded medications and ensuring compliance with federal laws.