What distinguishes a 503B facility from a 503A facility?

A 503B facility is distinguished primarily by its ability to mass-produce compounded medications. This characteristic allows a 503B facility to manufacture larger batches of compounded drugs that can be distributed to healthcare facilities without being tied to specific patient prescriptions. This is significant because it enables hospitals and clinics to maintain a supply of compounded medications for patient care needs.

In contrast, a 503A facility compounds medications specifically for individual patients based on a physician’s prescription. As a result, 503A facilities operate under different regulatory standards that focus on patient-specific needs rather than larger distribution.

While 503B facilities do have requirements for regulatory compliance, the nature of their operations necessitates a more robust level of oversight, including the need to register with the FDA and adhere to Current Good Manufacturing Practices (CGMP). Thus, the ability to mass-produce compounded medications highlights the critical difference between these two types of facilities, making option C the correct answer.