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Are you Ready for Changes in Sterile Compounding Compliance?


Are You Ready for Changes to Compounding Compliance?


In late 2012, contaminated drugs from the New England Compounding Pharmacy in Framingham, Massachusetts, killed 64 and sickened more than 750 people nationwide.  NECC was found to be in violation of its state license and ultimately hit with a $200 million settlement. Since that event, regulatory bodies have ramped up scrutiny on hospital and health system pharmacies that compound medications for their patients.


New USP Standards


On June 1, the United States Pharmacopeia (USP) released revised standards that address the quality of compounded drugs. These updated USP standards are intended to ensure that healthcare practitioners have the guidance to consistently produce quality compounded drugs that are the right strength and quality for patients and are free of contaminants.


While enforcement of these new regulations is not slated to take effect until December 1, 2019, hospitals and health system pharmacies are under increasing pressure to be in compliance as soon as possible in order to meet the December 1 deadline.


Ronald T. Piervincenzi, PhD, CEO of USP stated, “We want to help ensure patient benefit and reduce risks. The updated USP standards will help ensure quality preparations for patients who rely on compounded medicines, while minimizing the risk of exposure to hazardous drugs for health care personnel.”


What Is Covered


The new and revised standards pertain to the USP General Chapters on compounded drugs and add a new standard for compounding radiopharmaceutical drugs:

  • USP <795> Pharmaceutical Compounding – Nonsterile Preparations
  • USP <797> Pharmaceutical Compounding – Sterile Preparations
  • USP <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing and Repackaging.


The revised standards recognize risks associated with non-sterile and sterile compounding and tighten controls in areas that directly affect the quality and safety of these compounded medicines.


The Time is Now to Prepare


As the USP enforcement date approaches, hospitals and health systems are urged to get ready for the upcoming deadline with a continuous readiness program that ensures success. While it can be challenging for hospital and health system pharmacies to implement these new standards, Comprehensive Pharmacy Services can help through their extensive training and experience in meeting USP compounding standards.


  • Expertise - CPS has delivered customized compounding consultative assessments for diverse compounding operations including:
    • Hospitals and infusion centers within one large health system including assessments for a health system with over 50 hospitals 
    • Small to medium hospital systems
    • Retail pharmacy compounding operations        
    • Day-to-day management of compounding operations for independent hospitals


  • Complete Site Assessment - Using CPS’ proprietary audit tool, CPS teams can help achieve:
    • General compliance with pharmaceutical compounding of sterile and non-sterile preparations
    • Current site registration/licensure for compliance with state regulations
    • Upgrading compounding work and storage areas, current facility design, equipment and engineering controls
    • Drafting or updating policies and procedures


  • Detailed Evaluation of Staff & Systems CPS expertise covers:
    • 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 safety practices from procurement to administration


Following assessment, CPS will deliver a written compliance report and provide a corrective action plan with detailed findings and recommendations to bring your compounding pharmacy into regulatory compliance.


The time is now to prepare for the December 1 deadline. Learn more about how CPS can help your organization be ready.

Posted: Wednesday, September 25, 2019

Tags: Blog