The Importance Of 503B Facilities In Drug Manufacturing Today

By James Calle

Precise product implementation is crucial due to the nature and function of compounding pharmacies, so it is vital that the highest standards are employed in their drug manufacturing processes. While it’s true that 503Bs are held to higher regulatory standards than 503As—large-scale compounding pharmacies are required to adhere to cGMP standards—both are largely required to adhere to both USP 795 and 797. Moreover, both are facing greater scrutiny due to the fact that their role in public health is still developing. The scrutiny signifies maturation and growth for the compounding pharmacy sector. As more people look to utilize personalized medicine out of their own homes, it is reasonable to assume that improved state and federal regulatory standards will be a subject of ongoing conversation.

As 503A and 503B pharmacies look to expand, the demand for several different products in multiple formats is a significant production challenge. Here, we share one of the best ways to ensure sterility in aseptic compounding operations and how compounding pharmacies can achieve the adaptability they need to scale their operation.