South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is the primary responsibility of an Outsourcing Facility under the FDA?

1. Manufacturing non-sterile compounded drugs

2. Compounding sterile drugs

3. Selling over-the-counter medication

4. Only providing medications to healthcare providers

The correct answer is: Compounding sterile drugs

The primary responsibility of an Outsourcing Facility under the FDA is to compound sterile drugs. This distinction is crucial as Outsourcing Facilities are specifically designed to produce compounded sterile drug products that can be distributed to healthcare providers without requiring individual patient prescriptions, provided they adhere to certain regulatory standards. These facilities must comply with Good Manufacturing Practices (GMP) and are subject to more stringent oversight compared to traditional compounding pharmacies. This regulatory framework is established to ensure the safety and quality of sterile preparations, addressing significant public health concerns related to compounded medications. The other options do not accurately reflect the role of Outsourcing Facilities. Manufacturing non-sterile compounded drugs falls outside their designated responsibilities, as well as selling over-the-counter medications which are typically handled by retail pharmacies and do not require the specialized compounding procedures. Similarly, while Outsourcing Facilities do provide medications to healthcare providers, their primary function is focused on the compounding of sterile products rather than exclusively serving as distributors.