Sterile Compounding

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.

Our Sterile Compounding Solution includes:

Independent Audit Services

  • A comprehensive audit and assessment of general compliance with pharmaceutical compounding of sterile preparations.
  • The assessment is based on the standards defined in United States Pharmacopeia Chapters <797>, and/or <800> and other applicable pharmacy practice standards and federal and state regulations.
  • Methodologies to determine compliance include direct observation, staff interviews, physical inspections of compounding records, primary engineering controls and other related clean room certification records.
  • Compliance Report (non-compliant indicators will be identified and overall levels of compliance with indicators will be scored), a Corrective Action Plan (recommendations for improvement are included as part of the Corrective Action Plan) and an executive level report.

Areas of focus include:

  • Compounding work and storage areas for appropriate ventilation, heating/cooling, lighting and sanitary condition
  • Personnel training, evaluation and competency assessment
  • Primary and secondary engineering controls
  • Physical plant and workflow design
  • Policies and Procedures
  • Hazardous drugs safety practices, environmental controls and monitoring

Continuous Readiness Program

  • Extended guidance and support by pharmacy practice specialists with robust program knowledge
  • Specialized assessment and ongoing assistance from industry-leading Sterile Compounding experts for extended term (multi-year agreement) with multi-year ongoing support and quarterly reviews and reports – not just a one-time consultation

Includes:

  • An annual audit of compounding practices and processes to validate current practices are compliant with the requirements of USP <797> and USP <800> and state regulations
  • Compliance Report (non-compliant indicators will be identified and overall levels of compliance with indicators will be scored), a Corrective Action Plan (recommendations for improvement are included as part of the Corrective Action Plan) and an executive level report
  • Monthly or quarterly follow up and consultative calls to evaluate status of Corrective Action Plan, improvements and barriers
  • Educational webinars on topics based on system-wide needs.

Assist Program

  • On-site support to deploy sterile compounding compliance initiatives and maintain action plans for each compounding location
  • Implementation guidance of the necessary steps to achieve compliance with USP <797>, USP <800> and state regulations through the combined use of monthly or quarterly on-site validation assessments and the generation of site-specific work plans
  • Monthly, or quarterly on-site validation assessment of corrective action to include:
    • Review of selected non-compliant USP Action Plan items
    • Evaluation of quality assurance and performance improvement plan and activities related to sterile compounding
    • Consultation with appropriate staff on initiatives and progress
  • Monthly on-site and remote planning meetings with staff and leadership to discuss plans, activities and updates.
  • Remote support from other Corporate Specialists for questions and consultation as needed
  • Compliance Report (non-compliant indicators will be identified and overall levels of compliance with indicators will be scored), a Corrective Action Plan (recommendations for improvement are included as part of the Corrective Action Plan) and an executive level report
  • Educational sessions and webinars (live or recorded) with topics based on system-wide needs.
  • Assistance with education and training, skills development and competency assessment
  • Construction plan modifications and provide continued support through completion of new pharmacy spaces, if applicable.
  • Tools and resources to assist with monitoring and maintaining a state of readiness for future sterile compounding inspections by regulators including:
    • Staff competency assessment
    • Environmental sampling plan
    • Cleaning program
    • Product standardization
    • Environmental monitoring program