Under the Drug Quality and Security Act, which criteria define an outsourcing facility?

Under the Drug Quality and Security Act, which criteria define an outsourcing facility?

• A. It compounds sterile drugs
• B. It is registered with the FDA as outsourcing facility
• C. It complies with CGMP requirements and FDA inspections
• D. It meets all of the above

Answer: (D)

All of these criteria together define an outsourcing facility. Under the Drug Quality and Security Act, an outsourcing facility is a site that compounds sterile drugs, registers with the FDA specifically as an outsourcing facility, and operates under current good manufacturing practice (CGMP) with FDA inspections. Each piece matters: sterile compounding is the core service that the 503B pathway covers; registration with the FDA establishes the facility within the outsourcing framework and enables oversight and reporting requirements; and adherence to CGMP along with routine FDA inspections ensures the quality, safety, and consistency expected of manufacturing-like operations, not just traditional compounding. When all three are met, the entity is properly classified as an outsourcing facility.

All of these criteria together define an outsourcing facility. Under the Drug Quality and Security Act, an outsourcing facility is a site that compounds sterile drugs, registers with the FDA specifically as an outsourcing facility, and operates under current good manufacturing practice (CGMP) with FDA inspections. Each piece matters: sterile compounding is the core service that the 503B pathway covers; registration with the FDA establishes the facility within the outsourcing framework and enables oversight and reporting requirements; and adherence to CGMP along with routine FDA inspections ensures the quality, safety, and consistency expected of manufacturing-like operations, not just traditional compounding. When all three are met, the entity is properly classified as an outsourcing facility.