South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which entity needs a 503B permit?

1. Independent pharmacies

2. Outsourcing facilities that must meet cGMP standards

3. Retail pharmacies selling compounded products

4. Pharmacies offering prescription drugs only

The correct answer is: Outsourcing facilities that must meet cGMP standards

The entity that requires a 503B permit is an outsourcing facility that meets current Good Manufacturing Practice (cGMP) standards. This classification was established under the Drug Quality and Security Act to allow certain facilities to compound sterile drugs for distribution. These outsourcing facilities are highly regulated and must comply with specific cGMP regulations to ensure the safety, quality, and effectiveness of their compounded products. Obtaining a 503B permit allows these facilities to produce larger batches of compounded medications for use in healthcare settings, and they must adhere to rigorous standards to maintain this certification. This contrasts with other types of pharmacies that operate under different regulations or permits. Independent pharmacies and retail pharmacies that sell compounded products generally do not need a 503B permit if they are compounding medications for individual patients as part of standard pharmacy practice. Likewise, pharmacies that only offer prescription drugs without compounding may not be involved with the compliance measures associated with 503B. Therefore, the need for a 503B permit is specifically tied to outsourcing facilities that compound sterile medications for broader distribution under strict manufacturing standards.