West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Do the requirements for wholesale drug distributors in West Virginia include registration with the FDA as Outsourcing Facilities?

1. Yes, it is mandatory

2. No, only a distributor license is required

3. No, no registration is needed

4. Yes, for both in-state and out-of-state distributors

The correct answer is: Yes, it is mandatory

The requirement for wholesale drug distributors in West Virginia includes registration with the FDA as Outsourcing Facilities, which aligns with option A being the correct choice. Outsourcing Facilities are defined under the Drug Quality and Security Act and are required to register with the FDA to ensure they comply with specific provisions, particularly when they engage in the compounding of sterile drugs. This federal registration requirement is critical to maintaining oversight and ensuring that compounded drugs meet safety and quality standards. Therefore, for wholesale drug distributors operating in a manner that involves compounding and distributing sterile drugs, registration with the FDA as an Outsourcing Facility is mandatory. While options suggesting different views may highlight aspects of state licenses or distribution practices, they do not account for the specific federal regulation that applies in conjunction with state guidelines. The combination of both sets of regulations ensures comprehensive oversight in drug distribution practices.