What compliance requirements must an outsourcing facility meet?

The compliance requirement that outsourcing facilities must meet includes adhering to Current Good Manufacturing Practice (CGMP) requirements and being subject to inspections by the Food and Drug Administration (FDA). This is crucial because outsourcing facilities, which compound sterile drugs, are required to maintain a high standard of quality to ensure patient safety and effectiveness of medications. CGMP regulations are designed to ensure that drug products are consistently produced and controlled according to quality standards.

Being subject to FDA inspections allows for regulatory oversight, ensuring that these facilities are following the required protocols that protect public health. This requirement is an integral part of ensuring that compounded preparations meet the necessary safety and efficacy standards expected in the pharmaceutical industry.

While compliance with state pharmacy statutes, obtaining licenses, and facilitating access to compounded drugs may be relevant considerations for pharmacies and other entities, the specific and critical compliance focus for outsourcing facilities centers around CGMP adherence and FDA regulatory oversight.