What are outsourcing facilities required to comply with?

Outsourcing facilities are required to comply with Current Good Manufacturing Practice (CGMP) requirements as established by the FDA. These regulations are essential to ensure the quality, safety, and efficacy of compounded medications produced by these facilities. CGMP standards encompass various aspects of the manufacturing process, including the proper design, monitoring, and control of manufacturing processes and facilities. Compliance with CGMP is critical to preventing contamination, mix-ups, and errors in the production of pharmaceuticals and ensuring that the final products meet the intended specifications for quality.

While state-level regulations, local business licenses, and employee training guidelines may also be important for the operation of an outsourcing facility, they do not specifically encompass the comprehensive set of standards provided by CGMP. CGMP serves as a baseline for manufacturing practices and is a federal requirement that must be adhered to by outsourcing facilities engaged in compounding sterile drugs for distribution. Thus, adherence to CGMP is a foundational aspect of compliance for these facilities in the pharmaceutical supply chain.