Some outsourcing facility licenses may require what to be listed as the responsible person?

• A. A physician
• B. A nurse
• C. A licensed pharmacist
• D. A pharmacist’s assistant

Answer: (C)

The key idea is who oversees and ensures compliance for an outsourcing facility’s compounding operations. The responsible person must have the authority and expertise to supervise sterile preparation, validate procedures, maintain quality systems, and ensure all regulatory requirements are met. A licensed pharmacist is uniquely qualified for this role because they hold the professional licensure and pharmacology/journal of practice knowledge needed to oversee compounding, review batch records, ensure adherence to standards (like USP <797>), and handle regulatory compliance.

Physicians may provide medical direction, but the regulatory and daily oversight of compounding quality is typically assigned to a pharmacist. Nurses and pharmacist’s assistants do not have the required licensure to supervise sterile compounding and regulatory compliance, so they are not usually listed as the responsible person.