South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

For what purpose is an Outsourcing Facility (503B) permit required?

1. Compounding of non-sterile drugs

2. Compounding of sterile drugs registered with the FDA

3. Distributing non-prescription medications

4. Only for veterinary drugs

The correct answer is: Compounding of sterile drugs registered with the FDA

An Outsourcing Facility permit is specifically required for the compounding of sterile drugs registered with the FDA. This designation is part of the Drug Quality and Security Act, which established the distinction between traditional compounding pharmacies and outsourcing facilities to ensure a higher level of oversight for sterile compounding practices. Outsourcing Facilities are permitted to produce sterile compounded medications in large quantities without the need for individual prescriptions. The requirement for FDA registration is intended to enhance safety and quality control measures in the compounded drug supply, addressing risks associated with contamination and ensuring compliance with strict guidelines for sterile manufacturing. This role is critical, especially in providing compounded sterile preparations to healthcare entities, as it provides assurance to patients and providers that these drugs meet stringent quality standards established by regulatory authorities.