If an outsourcing facility compounds prescription drug products, how must these products be compounded?

When an outsourcing facility compounds prescription drug products, it must do so in accordance with Current Good Manufacturing Practice (CGMP) requirements. CGMP encompasses regulations enforced by the FDA that provide guidelines for the minimum design, monitoring, and control of manufacturing processes and facilities. These are essential to ensure that drug products are consistently produced and controlled according to quality standards.

By adhering to CGMP, an outsourcing facility ensures the identity, strength, quality, and purity of its compounded products. Compliance with these standards is crucial in maintaining the safety and effectiveness of the medications compounding processes, which are susceptible to variations and quality risks if not properly regulated.

The other options, while relevant to some extent, do not provide the complete and necessary regulatory framework required for compounding. Standard operating procedures are important, but they must be developed within the broader context of CGMP. Compounding in bulk batches is a specific practice that can be a part of operations but is not a requirement for all compounding. Lastly, performing any compounding without regulatory oversight would not align with the established practices and expectations of maintaining drug quality and safety.