What describes an outsourcing facility in the context of sterile drug preparation?

• A. A facility located in multiple locations that compounds on demand
• B. A facility that distributes finished drugs nationwide
• C. A facility located at one geographical location that is engaged in anticipatory compounding of sterile drugs and complies with FDA section 503B of the FDC act
• D. A facility that only supplies non-sterile compounded products

Answer: (D)

Outsourcing facilities under FDA 503B are dedicated to sterile drug production in bulk for distribution to healthcare facilities, operating under cGMP and registered with the FDA. They’re designed to allow anticipatory compounding—stockting sterile products so hospitals and clinics can access ready-to-use medications—rather than just compounding individual prescriptions for a specific patient.

The description that fits best is a facility located at a single geographical location that engages in anticipatory compounding of sterile drugs and complies with FDA section 503B. This captures the essential characteristics: sterile, bulk compounding under 503B, with the ability to stock and distribute to healthcare providers.

Why the other descriptions don’t fit: a facility described as having multiple locations isn’t the defining feature, since outsourcing facilities can operate at several sites but that isn’t what defines them. A facility that distributes finished drugs nationwide speaks to manufacturers or distributors of finished dosage forms, not to 503B outsourcing facilities. A facility that only supplies non-sterile compounded products misses the key focus of 503B, which is sterile drug compounding.