The need for compliance has never been higher with state and federal regulators increasing inspections of compounding pharmacies and implementation of new requirements for hazardous drugs.

We partner with pharmacies across the country to assist in assessments of their operations so the sterile preparations they provide are safe for patients and meet state and federal requirements. We have the necessary tools you need to meet regulation requirements. CPS’ expert team of specialists are equipped with extensive training and experience to help you mitigate risk by guiding your program to meet USP 797 and 800 requirements.

CPS has delivered over 250 customized sterile compounding consultative assessments for diverse compounding operations:

  • 90 hospitals and infusion centers within one large health system
  • Small to medium hospital systems
  • Retail pharmacy compounding operations
  • USP 797 and 800 assessments for a health system with over 50 hospitals
  • Day-to-day management of compounding operations for over 150 independent hospitals

Using CPS’ proprietary audit tool:

  • General compliance with pharmaceutical compounding of sterile and non-sterile preparations
  • Current site registration/licensure for compliance with state regulations
  • Compounding work and storage areas, current facility design, equipment and engineering controls
  • Policies and procedures

Detailed Evaluation of Staff & Systems:

  • Personnel Training, Evaluation and Competency Assessment
  • Evaluation of Primary and Secondary Engineering Controls
  • Operational Review of physical plant
  • Procedures for pharmacy driven sterile compounding operation
  • Workflow design to optimize safety and efficiency
  • Quality management process review and management
  • Evaluation of hazardous drugs (HD) safety practices from procurement to administration