Authentication of an outsourcing facility should include checks with which parties?

• A. FDA only
• B. The state licensing agency where the facility is located
• C. The state licensing agency in both the facility state and the receiving state
• D. No authentication required

Answer: (C)

Cross-state regulatory verification is essential when working with outsourcing facilities. While FDA registration shows federal oversight of a 503B facility, state boards of pharmacy regulate who may manufacture or distribute within their borders. Checking licensure with the state where the facility operates and with the state where the drugs will be used ensures the supplier is legally authorized in its home state and that the receiving state accepts suppliers from outside its jurisdiction. This dual verification helps protect patient safety, supports regulatory compliance across states, and aids with recall and accountability if issues arise. Relying on FDA status alone misses state-level requirements, and verifying only one state’s licensure could leave gaps where a facility is not properly authorized to operate or distribute in the other state. Skipping authentication altogether is not compliant with best practices for ensuring legitimate, licensed suppliers.