Non-patient-specific sterile compounded drug preparations may be provided without a patient-specific prescription if which conditions apply?

• A. The entity is registered with the FDA as an outsourcing facility under section 503B
• B. The entity is licensed by boards of pharmacy in states they ship into, usually as a wholesaler with an outsourcing classification
• C. The entity must include a licensed pharmacist as the responsible person on this license
• D. All of the above

Answer: (D)

Non-patient-specific sterile compounded drug preparations can be supplied without a patient-specific prescription when the facility operates under the 503B outsourcing model, with three essential requirements. First, the entity must be registered with the FDA as an outsourcing facility under section 503B, which allows large-batch sterile product manufacturing for use in healthcare settings. Second, the facility must be licensed by the boards of pharmacy in the states it ships into, typically as a wholesaler with an outsourcing classification, ensuring state-level regulatory oversight. Third, there must be a licensed pharmacist designated as the responsible person on the license, providing professional supervision and accountability. When all of these conditions are met, non-patient-specific sterile products can be provided without individual prescriptions.