The University of Wisconsin Health System (UW Health) was required to meet the complex needs of their patients with intrathecal pain pump compounded medications. The health system looked for a partner who could quickly integrate outsourced compounding services. An established regulatory-compliant program would enhance patient outcomes while increasing pharmacy, provider, and patient satisfaction.

Regulatory challenges are evolving and complex

Regulations for outsourced pharmacy needs are critical for safe patient care but pose significant challenges to health systems that utilize 503A pharmacies for outsourced compounded medications. 

The Joint Commission requires that outsourced pharmacies meet or exceed United States Pharmacopeia (USP) Chapter 797 standards. USP 797 presents unique challenges for Category 3 compounding of sterile preparations, including increased sterility testing, staff training and competencies, and significant facility investments. Health systems must ensure that standard operating procedures (SOPs) reflect these standards, which require intensive, time-consuming administrative and operational challenges. Read More >