South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

True or False: An outsourcing facility must apply for a South Carolina pharmacy/manufacturer permit if it is not located in South Carolina.

1. True

2. False

3. Only if it plans to sell medications in South Carolina

4. Only if it compounds controlled substances

The correct answer is: True

An outsourcing facility must apply for a South Carolina pharmacy/manufacturer permit even if it is not located in South Carolina. This requirement is rooted in the need for regulatory oversight and ensuring that the facility complies with state laws regarding pharmacy practice and manufacturing standards. South Carolina, like many states, aims to protect its residents from pharmaceutical products that may not meet the necessary safety and efficacy standards, regardless of the facility’s physical location. If an outsourcing facility is compounding sterile drugs for distribution, it must adhere to South Carolina's regulations that govern such practices, which includes obtaining the appropriate permits. This is in line with the overarching goal to maintain safety in the distribution of medications, ensuring that all facilities, regardless of their geographical location, are held to the same regulatory standards when their products enter the South Carolina market. The requirement for a permit applies universally to protect public health and ensure that all pharmacies and manufacturers meet compliance requirements within the state.