West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Manufacturing is regulated by ____; compounding is regulated by ____ except for requirements for outsourcing facilities.

1. FDA, DEA

2. FDA, state boards

3. DEA, state boards

4. State boards, FDA

The correct answer is: FDA, DEA

The regulation of manufacturing and compounding in pharmaceuticals is a crucial distinction in pharmacy law. Manufacturing is primarily under the oversight of the FDA. This is because manufacturing involves the production of large quantities of medications that are intended for commercial distribution, which is subject to strict federal manufacturing regulations, safety, and efficacy standards. On the other hand, compounding—specifically, the preparation of customized medications for individual patients—is largely regulated by state boards of pharmacy. State boards establish the conditions under which compounding is permissible, ensuring that compounding practices meet necessary safety and quality standards for patient-specific needs. However, when it comes to outsourcing facilities, they fall under the jurisdiction of the FDA due to the scale of their operations and the potential impact on public health. Outsourcing facilities can produce larger quantities of compounded medications but must adhere to specific FDA regulations. Understanding this regulatory framework is essential for any pharmacy professional, as it defines responsibilities and standards of practice that must be maintained in both manufacturing and compounding processes.