Which entity licenses outsourcing facilities?

• A. Federal agencies
• B. State boards of pharmacy
• C. Local health departments
• D. Private certification bodies

Answer: (B)

Outsourcing facilities are licensed by the state boards of pharmacy. They operate as pharmacies under state law, so the licensing authority rests with the state board rather than federal agencies or local health departments. The FDA requires these facilities to register as 503B outsourcing facilities and to comply with CGMP and inspections, but licensing to operate is a state-level responsibility. Private certification bodies may certify compliance, but they do not grant licenses.