Which federal designation allows an entity to provide non-patient-specific sterile compounded drug preparations?

• A. 501A Pharmacist
• B. 503B Outsourcing Facility
• C. 510K Medical Device
• D. 704C Pharmacy Permit

Answer: (B)

The ability to provide non-patient-specific sterile compounded drug preparations comes from the FDA-regulated outsourcing facility designation. An outsourcing facility compounds sterile products in bulk for use in hospitals and clinics, without a prescription tied to a single patient, and ships them to healthcare settings. They operate under current good manufacturing practices and are subject to FDA oversight and inspections, which supports consistent quality for products used across multiple patients. This setup is different from traditional compounding, which is patient-specific and typically overseen by state boards for pharmacist-initiated prescriptions. Devices regulation (510K) and unrelated permits don’t apply here.