If a sterile compounding entity is not registered as 503B or 503A, how will the FDA regard them?

If a sterile compounding entity is not registered as either a 503B (outsourcing facility) or 503A (traditional compounding pharmacy), the FDA will regard them as a manufacturer. This classification stems from the FDA's regulatory framework that distinguishes between compounding practices and manufacturing processes.

Entities that do not operate under the guidelines of 503B or 503A essentially step outside the intended legal boundaries for compounding pharmacies. The key difference is that manufacturers are typically subject to stricter regulations regarding the production of pharmaceutical products, including adherence to Good Manufacturing Practices (GMP). Therefore, without that registration, an entity engaged in sterile compounding is viewed as conducting manufacturing activities, which include producing drugs for wider distribution rather than tailored patient-specific medications.

This classification carries significant implications for the compounding entity in terms of regulatory compliance, as manufacturers are liable for meeting all FDA requirements applicable to pharmaceutical production and distribution, such as facility inspections, reporting, and quality control standards.

Other classifications, like being labeled as a hospital pharmacy or a volunteer facility, do not appropriately capture the regulatory expectations placed upon an unregistered compounding entity. Hence, the status of being regarded as a manufacturer accurately reflects the FDA’s oversight and the necessary compliance that comes with such