Ace the West Virginia MPJE 2026 – Pharmacist Pro Power-Up!

The correct answer emphasizes that outsourcing facilities must compound drugs in compliance with Current Good Manufacturing Practices (CGMP), pay a fee to the FDA, and are subject to FDA inspections. These requirements ensure that the compounded drugs are produced with a high level of quality and safety, aligning with regulatory standards set forth to protect public health.

Compounding under CGMP means that the facility adheres to rigorous manufacturing standards, which are critical for ensuring that drugs are consistently produced and controlled according to quality standards. The requirement to pay a fee to the FDA allows for the regulatory oversight necessary to monitor these facilities effectively. Furthermore, being subject to FDA inspections means that the facilities are held accountable to federal standards, promoting compliance and discouraging malpractice.

Other options suggest varying degrees of adherence to standards and inspections, but do not meet the complete and stringent criteria established in Section 503B of the Drug Quality and Security Act for outsourcing facilities. They may imply lesser oversight or incorrect fee structures, which would not fulfill the protective measures aimed at maintaining drug quality and safety in outsourced compounded medications.