For non-patient-specific sterile compounded drug preparations, which combination of conditions is typically required?

• A. The entity is registered with the FDA as a 503B outsourcing facility
• B. The entity is licensed by boards of pharmacy in states they ship into
• C. The entity must include a licensed pharmacist as the responsible person
• D. All of the above

Answer: (D)

Non-patient-specific sterile compounded drug preparations are typically produced by 503B outsourcing facilities, which are FDA-registered and operate under sterile cGMP to manufacture ready-to-use products for wide distribution. Because these products move across state lines, the facility must be licensed by the boards of pharmacy in the states it ships into, ensuring compliance with state laws where the drugs are used. In addition, there must be a licensed pharmacist designated as the responsible person to supervise the compounding operations, oversee quality control, and accept accountability for regulatory compliance. When you combine these elements—the FDA-registered 503B status, state board of pharmacy licensure for interstate distribution, and a licensed pharmacist as the responsible person—you get the typical setup for non-patient-specific sterile compounded preparations.